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HORIZON SCANNING P UPATE JULY 2010 - Keele University€¦ · 6 Studies With Vitamin D Phase II...
Transcript of HORIZON SCANNING P UPATE JULY 2010 - Keele University€¦ · 6 Studies With Vitamin D Phase II...
© Arthritis Research UK 2010
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HORIZON SCANNING: PAEDIATRIC RHEUMATOLOGY
UPATE JULY 2010
The object of these Horizon Scanning reports is to highlight recently completed and ongoing clinical trials, research recommendations and new and emerging health technologies. After feedback from a pilot Horizon Scanning exercise and following consultation with the MCRN/ARC Paediatric Rheumatology CSG lead, these Horizon Scanning reports only highlight ongoing clinical trials or those completed since 2008. This follow up report includes trials registered since December 2009 for five of the Topic Specific Groups (TSGs): Dermatomyositis; Juvenile-idiopathic arthritis and associated uveitis; Juvenile systemic lupus erythematosus; and Vasculitis. In addition, two further TSGs - Bone Health and Non-inflammatory - are included in this report outlining studies ongoing or completed since 2008. Details of all material included in this report are shown in the appendix, sorted according to TSG. Further details of each study can be obtained via the links given to the relevant webpage.
CONTENTS
SEARCH METHODOLOGY 2 RESULTS 3 ABBREVIATIONS 4 APPENDIX: CLINICAL TRIALS 5
A1. Bone Health……………………………………………………………………………………………. 5 A1a: Calcinosis, Hyper- & Hypo-Calcaemia 5 A1b: Dysplasia & McCune Albright syndrome 6 A1c: Osteogenesis imperfecta 9 A1d: Osteopetrosis 11 A1e: Osteoporosis 13 A1f: (Juvenile) Paget’s disease 18 A1g: Rickets & Hypophophatasia 18
A2. Dermatomyositis……………………………………………………………………………………. 22 A3. Juvenile Idiopathic Arthritis and JIA-associated Uveitis………………………………… 23 A4. Juvenile onset Systemic Lupus Erythematosus……………………………………….. 25 A5. Non-inflammatory………………………………………………………………………………….. 28
A5a: Chronic pain syndrome, Complex regional pain syndrome & Fibromyalgia 28 A5b: Hypermobility, Joint hypermobility syndrome & ehlers-Danlos 32
A6. Scleroderma…………………………………………………………………………………………… 33 A7. Vasculitis……………………………………………………………………………………………….. 34
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SEARCH METHODOLOGY
Databases Searched Clinical trials databases: MetaRegister of Clinical Trials (active registers); ClinicalTrials.gov; UKCRN Portfolio Database; Australia and New Zealand Horizon Scanning Network (ANZHSN); MRC Clinical Trials Unit; Nederlands Trials Register; German Clinical Trials Register. Keywords searched Keywords and phrases were used separately or in combination; truncation was used where possible/applicable.
Bone health: Calcinosis, Hypercalc[a]emia, Hyperphosphatasemia, Hypocalc[a]emia, Hypophosphatasia, Juvenile Paget’s disease, McCune Albright syndrome, Osteogenesis imperfecta, Osteopetrosis, Osteoporosis (juvenile idiopathic, glucocorticoid-induced/steroid-induced, disuse, pseudoglioma syndrome), Polyostotic fibrous dysplasia, Rickets (vitamin D deficiency, hypophosphataemic; pseudo-D deficiency; hereditary vitamin D resistant rickets), Skeletal dysplasia;
Dermatomyositis;
JIA, Juvenile idiopathic arthritis, juvenile rheumatoid arthritis, juvenile chronic arthritis, Oligoarticular juvenile arthritis, Pauciarticular juvenile arthritis, Polyarticular juvenile arthritis, Still's disease, JIA associated uveitis, Idiopathic uveitis, Autoimmune uveitis;
[Juvenile-onset] systemic lupus erythematosus, SLE, lupus nephritis;
Non-inflammatory: Chronic pain syndrome, Complex regional pain syndrome, Ehlers-Danlos, Fibromyalgia, Hypermobility, Joint Hypermobility Syndrome;
Scleroderma, Systemic sclerosis;
Vasculitis, Kawasaki Disease, Mucocutaneous Lymph Node Syndrome, Behcet’s Syndrome, Wegener’s Granulomatosis, Microscopic Polyangiitis (MPA), Microscopic Polyarteritis, Polymyalgia rheumatic, Renal limited vasculitis, Cryoglobulinaemic vasculitis, Cogan’s syndrome, Takayasu’s Arteritis, Churg-Strauss Syndrome, Polyarteritis Nodosa, ANCA associated vasculitis, Henoch Schonlein purpura;
Child, Children, Childhood, Adolescent, Juvenile, Paediatric. Date limits For Bone Health and Non-inflammatory TSGs: trails completed or ongoing in 2008-July 2010. For the remaining five TSGs: trails registered since December 2009. Age limits Studies involving individuals of 18 years of age and under were included in the report.
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RESULTS
A total of 132 completed or ongoing clinical trials were identified across the seven topic areas included within paediatric rheumatology. These are tabulated in the appendix divided into sections:
A1: Bone Health (n = 78, since January 2008);
A2: Dermatomyositis (n = 2, since December 2009);
A3: Juvenile idiopathic arthritis and JIA-associated uveitis (n = 8, since December 2009);
A4: Juvenile-onset systemic lupus erythematosus (n = 10, since December 2009);
A5: Non-inflammatory (n = 25, since January 2008);
A6: Scleroderma (n = 1, since December 2009);
A7: Vasculitis (n = 8, since December 2009). For clarity each section is subdivided according to type of intervention: behavioural, education & exercise including physiotherapy; device; drug including biologics; procedure; other interventions including CAM; and no intervention, observational. Within each division, studies have been classified according to age group involved: ≤18 years (child) or all age groups (child and adult (including senior)) or age group unknown, and then arranged in descending chronological order of anticipated completion-date. (Trials where the end date was not specified are included based update the last update status e.g. recruitment complete etc, and follow-up time points if applicable.) Unless otherwise stated in the table trials involve participants of both genders. Each clinical study has a weblink which can be followed for further details. Where there was uncertainty regarding whether a study should be included or not (usually due to its focus), the decision aired on the side of caution and the trial was included in the feedback.
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ABBREVIATIONS
Adt Adult (18-65 years) ANCA Anti-neutrophilic Cytoplasmic Antibody Child Child (birth-17 years) Comp Completed CRPS Chronic Regional Pain Syndrome CT Controlled trial CT ID Clinical Trials Identifier DM Dermatomyositis F-only Females only Grps Groups HPV Human Papillomavirus Invite Invite only JIA Juvenile Idiopathic Arthritis M-only Males only MMR Measles, Mumps and Rubella MTX Methotrexate n Enrollement N/K Not known RA Rheumatoid Arthritis RCT Randomized controlled trial. Rec Recruiting Recruit Recruitment Sen Senior (66+ years) SLE Systemic Lupus Erythematosus Susp Suspended. TCM Traditional Chinese Medicine Term Terminated TMJ Temporomandibular Joint Wtdwn Withdrawn
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FULL TEXT APPENDIX
SECTION B: CLINICAL TRIALS Clinical trials identity number (CT ID): Prefix of NCT denotes National Clinical Trials Identifier and ISRCTN an International Standard Randomized Controlled Trial Number; UKCRN – UK Clinical Research Network; ACTRN – Australian New Zealand Clinical Trials Registry; NTR – Nederland Trial Register; DRK – German clinical Trials Register. Note: Where no end date was given the following were used: completion date for primary outcome measure – italics; last update – preceeded with a ?; start date + final timepoint of outcomes – preceeded with a >.
A1: BONE HEALTH
A1A: CALCINOSIS, HYPER- & HYPO-CALCAEMIA
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
All age groups
Study of 1.25 Mmol/L Calcium Dialysate on Mineral Metabolism in Haemodialysis Patients. Phase II: RCT (active), Safety/Efficacy Study NCT00744302
Physiological (1.25 mmol/L ) calcium dialysate
Hyperparathyroidism; Hypercalcemia
Active, NR
180 14-65 years
Child Adt
Apr-06 Dec-09 Sun Yat-sen University
http://ClinicalTrials.gov/show/NCT00744302
Age group unknown
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast® Phase IV: Single Group Assignment, Safety Study NCT00668200
Reclast® Paget's Disease of the Bone; Hypocalcemia
Rec 300 N/K
May-08 Jan-10 Novartis Pharmaceuticals
http://ClinicalTrials.gov/show/NCT00668200
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Studies With Vitamin D Phase II NCT00001151
1,25-Dihydroxychole-calciferol
Hypocalcemia; Rickets Comp 200 N/K
Mar-76 Oct-09 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
http://ClinicalTrials.gov/show/NCT00001151
No intervention: observational
All age groups
Studies of Inherited Diseases of Metabolism NCT00001345
Hypercalcemia; Hyperparathyroidism; Multiple Endocrine Neoplasia
Rec N/K Child Adt Sen
Apr-93 ? Last
update jul-10
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
http://ClinicalTrials.gov/show/NCT00001345
Studies of Elevated Parathyroid Activity NCT00001277
Hyperparathyroidism; Hypocalcemia; Hypoparathyroidism; Parathyroid Neoplasm
Rec N/K Child Adt Sen
Mar-91 ? Last
update Jul-10
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
http://ClinicalTrials.gov/show/NCT00001277
Resistance to Vitamin D or Parathyroid Hormone NCT00001242
Hypocalcemia; Osteomalacia; Pseudohypoparathyroidism; Pseudopseudohypoparathyroidism; Rickets
Rec N/K >1 year
Child Adt Sen
Sep-89 ? Last
update Jul-10
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
http://ClinicalTrials.gov/show/NCT00001242
A1B: DYSPLASIA & MCCUNE ALBRIGHT SYNDROME
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
≤18 years
Faslodex in McCune Albright Syndrome Phase II: Single Group Assignment, Safety/Efficacy Study NCT00278915
Fulvestrant Puberty, Precocious; McCune-Albright Syndrome
Active, NR
30 <10 years
Child
F-
only
Nov-05 Dec-16 AstraZeneca http://ClinicalTrials.gov/show/NCT00278915
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Arimidex in McCune Albright Syndrome Phase II: Single Group Assignment, Safety/Efficacy Study NCT00055302
Arimidex 1 mg McCune-Albright Syndrome
Active, NR
30 <10 years
Child
F-
only
Aug-02 Mar-15 AstraZeneca http://ClinicalTrials.gov/show/NCT00055302
A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI Phase IV: RCT (dose comparison), Safety/Efficacy Study NCT00299000
Galsulfase Mucopolysaccharidosis VI; Maroteaux-Lamy Syndrome; prevention of progressive skeletal dysplasia
Active, NR
4 <1 year
Child
Sep-07 Dec-09 BioMarin Pharmaceutical
http://ClinicalTrials.gov/show/NCT00299000
Effects of Letrozole on Precocious Puberty Due to McCune Albright Syndrome Phase I NCT00006174
Letrozole McCune Albright Syndrome; Polyostotic Fibrous Dysplasia; Precocious Puberty
Comp 25 1-8 years
Child
F-
only
Aug-00 May-09 National Institute of Dental and Craniofacial Research (NIDCR)
http://ClinicalTrials.gov/show/NCT00006174
All age groups
Effect of Risedronate on Bone Morbidity in Fibrous Dysplasia of Bone Phase II/III: RCT (placebo), Efficacy Study NCT00445575
Risedronate; Placebo
Fibrous Dysplasia of Bone
Rec 156 ≥8 years
Child Adt Sen
Jul-07 Jul-14 Institut National de la Santé et de la Recherche Médicale, France; ZonMw: The Netherlands Organisation for Health Research & Development Cliniques universitaires Saint-Luc- Université Catholique de Louvain Charite University, Berlin
http://ClinicalTrials.gov/show/NCT00445575
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Other interventions including CAM
All age groups
Histamine Responsiveness in McCune-Albright Syndrome Prospective, Case Control NCT00318097
Histamine skin test McCune-Albright Syndrome
Rec 30 <40 years
ChildAdt
Nov-03 Children's Mercy Hospital Kansas City; KBR
http://ClinicalTrials.gov/show/NCT00318097
Age group unknown
Studies on Abnormal Bone From Patients With Polyostotic Fibrous Dysplasia and McCune Albright Syndrome NCT00001973
Genetics Polyostotic Fibrous Dysplasia
Comp N/K N/K
Dec-96 Dec-08 National Institute of Dental and Craniofacial Research (NIDCR)
http://ClinicalTrials.gov/show/NCT00001973
No intervention, observational
≤18 years
Prospective observational cohort study of children with hips dislocated at rest UKCRN ID 8037
Hip Dysplasia Active 500 0-18 mths
N/K Jan-14 International Hips Dysplacia Institute
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8037
All age groups
Evaluation and Treatment of Skeletal Diseases NCT00024804
Bone Disease Rec N/K Any age
Child Adt Sen
Sep-01 Last update Jul-10
National Institute of Dental and Craniofacial Research (NIDCR)
http://ClinicalTrials.gov/show/NCT00024804
Screening and Natural History of Patients With Polyostotic Fibrous Dysplasia and McCune-Albright Syndrome NCT00001727
Polyostotic Fibrous Dysplasia
Rec 200 ≥1 year
Child Adt Sen
Aug-98 Last update
National Institute of Dental and Craniofacial Research (NIDCR)
http://ClinicalTrials.gov/show/NCT00001727
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A1C: OSTEOGENESIS IMPERFECTA
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
≤18 years
Growth Hormone Therapy in Osteogenesis Imperfecta Phase III: Single Group Assignment, Efficacy Study NCT00001305
Humatrope; GRH; Nutropin
Dwarfism; Osteogenesis Imperfecta
Rec 60 1-15 years
Child
Nov-91 Sep-26 Eunice Kennedy Shriver National Institute of Child Health and Human Development
http://ClinicalTrials.gov/show/NCT00001305
An Efficacy and Safety Trial of Intravenous Zoledronic Acid in Infants Less Than One Year of Age, With Severe Osteogenesis Imperfecta Phase III: Single Group Assignment, Safety/Efficacy Study NCT00982124
Zoledronic Acid Osteogenesis Imperfecta
Rec 20 <12 mths
Child
Oct-07 Nov-12 Shriners Hospitals for Children; Novartis
http://ClinicalTrials.gov/show/NCT00982124
Repeated Infusions of Mesenchymal Stromal Cells in Children With Osteogenesis Imperfecta Phase I: Parallel Assignment (active), Safety/Efficacy Study NCT01061099
Mesenchymal Stromal Cells
Osteogenesis Imperfecta Type II; Osteogenesis Imperfecta Type III
Rec 12 <19 years
Child Adt
Feb-10 Sep-12 Children's Hospital of Philadelphia
http://ClinicalTrials.gov/show/NCT01061099
Pamidronate to Treat Osteogenesis Imperfecta in Children Phase III: Randomized, Parallel Assignment, Safety/Efficacy Study NCT00005901
Pamidronate (Aredia) Osteogenesis Imperfecta
Rec 60 <16 years
Child
Jun-00 Jun-10 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
http://ClinicalTrials.gov/show/NCT00005901
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children Phase III: RCT (placebo), Safety/Efficacy Study NCT00106028
Risedronate sodium (Actonel); Placebo
Osteogenesis Imperfecta
Active, NR
143 4-15 years
Child
Nov-04 Mar-10 Warner Chilcott http://ClinicalTrials.gov/show/NCT00106028
10
Prevention of Post Operative Bone Loss in Children RCT (placebo), Efficacy Study NCT00655681
Pamidronate; Saline Osteoporosis; Cerebral Palsy; Spina Bifida; Osteopenia; Osteogenesis Imperfecta
Rec 28 4-18 years
Child Adt
Sep-07 Feb-10 University of New Mexico; Thrasher Research Fund
http://ClinicalTrials.gov/show/NCT00655681
All age groups
Bisphosphonate Therapy for Osteogenesis Imperfecta Phase IV: Parallel Assignment, Safety/Efficacy Study NCT00159419
Alendronate; Pamidronate
Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone
Rec 30 3-21 years
Child Adt
Aug-99 Aug-08 Indiana University School of Medicine
http://ClinicalTrials.gov/show/NCT00159419
Other interventions including CAM
≤18 years
A Pilot study of Whole Body Vibration in Children with Osteogenesis Imperfecta RCT (active), Safety/Efficacy Study ACTRN12609000898257
Juvent vibration plate; standard care
Osteogenesis Imperfecta I-IV
Active, NR
30 2-18 years
Child
Jan-09 ? >Jan-10
Surgical Synergies Pty, Ltd; The Children’s Hospital at Westmead, Sydney
http://www.anzctr.org.au/trial_view.aspx?ID=307998
No intervention: observational
All age groups
Evaluation and Intervention for the Effects of Osteogenesis Imperfecta NCT00001594
Dwarfism; Osteogenesis Imperfecta
Rec 100 <25 years
Child Adt
Jan-97 Latest update Jul-10
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
http://ClinicalTrials.gov/show/NCT00001594
Age group unknown
Carrier Frequency of a Recurring Mutation Causing Recessive Type VIII Osteogenesis Imperfecta in African-Americans and Contemporary West Africans Retrospective NCT00605579
Osteogenesis Imperfecta
Rec N/K N/K
Jan-08 N/K Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
http://ClinicalTrials.gov/show/NCT00605579
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A1D: OSTEOPETROSIS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Device
All age groups
T-cell Depleted Alternative Donor Transplantation Phase II: Single Group Assignment, Efficacy Study NCT00968864
CliniMACS® (T cell depletion)
Osteopetrosis and other conditions
1
Rec 60 <30 years
Child Adt
Aug-09 Jun-19 Carolinas Healthcare System
http://ClinicalTrials.gov/show/NCT00968864
Drug including biologics
All age groups
Risk-Adapted Allogeneic Stem Cell Transplantation For Mixed Donor Chimerism In Patients With Non-Malignant Diseases Phase II/III: Parallel Assignment, Safety/Efficacy Study NCT01019876
Fludarabine; Cyclophosph-amide 200; Cyclophosph-amide 40; Cyclophosph-amide 30
Bone Marrow Failure; Osteopetrosis; Fanconi Anemia; Severe Combined Immune Deficiency
Rec 50 <30 years
Child Adt
Jun-02 May-13 Columbia University
http://ClinicalTrials.gov/show/NCT01019876
Procedure
≤18 years
Hematopoietic Stem Cell Transplantation for Malignant Infantile Osteopetrosis Phase II/III: Single Group Assignment, Efficacy Study NCT01087398
Stem Cell Transplantation [with Busulfan, Cyclophosphamide, Thymoglobulin, Fludarabine (Conditioning regimen) and Cyclosporin, Methotrexate (GVHD prophylaxis)]
Osteopetrosis Rec 10 <6 years
Child
Sep-09 Jul-11 Tehran University of Medical Sciences
http://ClinicalTrials.gov/show/NCT01087398
1 Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Chronic Myeloid Leukemia Chronic Myeloid Leukemia; Myelodysplastic Syndrome; Lymphomas; Bone Marrow
Failure; Hemoglobinopathy; Immune Deficiency
12
Stem Cell Transplantation for Children Affected With Osteopetrosis Single Group Assignment, Safety/Efficacy Study NCT00145587
Stem Cell Transplantation [Miltenyi Biotec CliniMACS device and systemic chemotherapy and antibodies]
Osteopetrosis Comp 28 Child
Jul-04 Feb-09 St. Jude Children's Research Hospital
http://ClinicalTrials.gov/show/NCT00145587
All age groups
Allogeneic Transplantation For Severe Osteopetrosis Phase II/III: Single Group Assignment, Safety/Efficacy Study NCT00775931
Stem Cell Transplantation + total Lymphoid Irradiation with either drug conditioning for transplantation-donor graft or for cord blood transplant
Severe Osteopetrosis
Rec 23 <45 years
Child Adt
Oct-08 Oct-15 Masonic Cancer Center, University of Minnesota
http://ClinicalTrials.gov/show/NCT00775931
Unrelated Hematopoietic Stem Cell Transplantation(HSCT) for Genetic Diseases of Blood Cells Phase I/II: Parallel Assignment NCT00730314
Hematopoietic stem cell transplantation
Sickle Cell Disease; Thalassemia; Anemia; Granuloma; Wiskott-Aldrich Syndrome; Chediak Higashi Syndrome; Osteopetrosis; Neutropenia; Thrombocytopenia; Hurler Disease; Niemann-Pick Disease; Fucosidosis
Rec 25 <21 years
Child Adt
Aug-08 Aug-12 Children's Hospital Los Angeles
http://ClinicalTrials.gov/show/NCT00730314
Reduced Intensity AlloTransplant For Osteopetrosis Phase II: Single Group Assignment, Safety/Efficacy Study NCT00638820
Stem Cell or Umbilical Cord Blood Transplantation; (Drug: Campath, Busulfan, Clofarabine; Procedure: Total Lymphoid Irradiation)
Osteopetrosis Term 3 <45 years
Child Adt
Sep-07 May-08 Masonic Cancer Center, University of Minnesota
http://ClinicalTrials.gov/show/NCT00638820
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A1E: OSTEOPOROSIS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy
≤18 years
Influence of External Factors on Skeletal Growth in Youth Single Group Assignment NCT00633828
Daily School physical education
Fractures; to understand the patho-physiology of osteoporosis
Active, NR
500 6-8 years
Child
Aug-99 Dec-15 Malmö University Hospital
http://ClinicalTrials.gov/show/NCT00633828
Adequate Dairy Intake on Weight Change in Girls RCT (active), Efficacy Study NCT01066806
Counseling on increasing calcium intake; normal calcium intake
Obesity; osteoporosis
Rec 274 13-14 years
Child
F-
only
Jul-08 Jul-13 Creighton University; National Institutes of Health (NIH)
http://ClinicalTrials.gov/show/NCT01066806
The effects of vitamin D supplementation on bone density in vitamin D insufficient teenagers: randomised controlled trial RCT (placebo) ACTRN12608000299303
Vitamin D; Placebo Osteoporosis N/K 670 15-17 years
Child
Jun-08 > Jun-10
Menzies Research Institute, Australia
http://www.anzctr.org.au/trial_view.aspx?ID=82894
Effect of High-Calcium Milk and Weight-Bearing Exercise on Bone Mineral Status of Pre-Pubertal Girls Randomized, Factorial Assignment NCT00979511
Milk and exercise Osteoporosis Active, NR
120 7-9 years
Child
F-
only
Feb-09 Apr-10 Nutrition Center of the Philippines; Nestle foundation
http://ClinicalTrials.gov/show/NCT00979511
All age groups
A randomised controlled trial of a brief walking intervention. RCT ISRCTN95932902
Brief walking intervention (including education, pedometer); usual care
Chronic conditions where activity shown to have positive effect including fibromyalgia and osteoporosis
Active 400 16-65 Years
Child Adt
Dec-09 May-11 Coventry University
http://www.controlled-trials.com/ISRCTN95932902
14
Dietary Supplement
≤18 years
Fructooligosaccharide and Calcium Absorption in Adolescent Girls Phase I/II: RCT (placebo), Efficacy Study NCT01005927
Fructooligo-saccharide
Osteoporosis Rec 26 10-12 years
Child
F-
only
Jan-09 Oct-09 Purdue University; Abbott Nutrition; GTC Nutrition
http://ClinicalTrials.gov/show/NCT01005927
All age groups
Zinc to Improve Bone Health in People With Thalassemia (The Think Zinc Study) Phase II: RCT (placebo), Efficacy Study NCT00480415
Zinc Supplements Thalassemia; associated osteoporosis
Active, NR
60 6-30 years
Child Adt
Apr-06 Dec-09 National Heart, Lung, and Blood Institute (NHLBI); Children's Hospital & Research Center Oakland; Children's Hospital of Philadelphia; University of California, San Francisco
http://ClinicalTrials.gov/show/NCT00480415
Drug including biologics
≤18 years
Growth Hormone Therapy and Bone Quality in Pediatric Osteoporosis Phase III: RCT (active), Efficacy Study NCT00757393
Humatrope + Vitamin D + Calcium + Exercise program; Vitamin D + Calcium + Exercise program
Osteoporosis Not yet Rec
28 5-16 years
Child
Sep-08 Jan-12 The Hospital for Sick Children
http://ClinicalTrials.gov/show/NCT00757393
15
The efficacy and safety of zoledronate in children and adolescents with chronic neurological conditions and osteoporosis: a crossover trial with long term follow up. Cross-over (active), Safety/Safety Study ACTRN12610000281099
First 6 months: Calcium 600mg + Vitamin D 400 IU; at 6 & 18 months Zoledronate IV + Calcuim & Vitamin D supplementation.
Osteoporosis associated with chronic neurological conditions.
Not yet rec
10 4-18 years
Child
Apr-10 ? >Oct-
12
Princess Margaret Hospital for Children, Subiaco, Australia
http://www.anzctr.org.au/trial_view.aspx?ID=335325
An Efficacy and Safety Trial of Intravenous Zoledronic Acid Twice Yearly in Osteoporotic Children Treated With Glucocorticoids for Chronic Inflammatory Conditions Phase III: RCT (placebo), Safety/Efficacy Study NCT00799266
Zoledronic acid; Placebo
Osteoporosis Rec 92 5-17 years
Child
Dec-08 Sep-10 Novartis http://ClinicalTrials.gov/show/NCT00799266
Prevention of Post Operative Bone Loss in Children RCT (placebo), Efficacy Study NCT00655681
Pamidronate; Saline Osteoporosis; Cerebral Palsy; Spina Bifida; Osteopenia; Osteogenesis Imperfecta
Rec 28 4-18 years
Child Adt
Sep-07 Feb-10 University of New Mexico; Thrasher Research Fund
http://ClinicalTrials.gov/show/NCT00655681
Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-Walking Children With Cerebral Palsy Phase III: RCT (placebo), Safety/Efficacy Study NCT00822029
Fosamax; Placebo
Osteoporosis; Cerebral Palsy
Not yet Rec
40 10-18 years
Child Adt
Feb-09 Aug-09 Centre Hospitalier Universitaire de Nice
http://ClinicalTrials.gov/show/NCT00822029
Effect of Different Doses of Budesonide on Markers of Bone Metabolism in Children With Asthma Phase IV: RCT (active), Safety Study NCT00487773
Budesonide; D3 vitamin; Montelukast sodium; Salbutamol
Asthma; affect on bone condition
Comp 96 5-18 years
Child Adt
Sep-07 Sep-08 Medical Universtity of Lodz
http://ClinicalTrials.gov/show/NCT00487773
Safety and Efficacy of Alendronate (Fosamax) in Children With Osteoporosis Phase II: RCT (placebo), Safety/Efficacy Study NCT00259857
Alendronate Osteoporosis Comp 22 5-15 years
Child
Oct-03 Mar-08 Medical University of South Carolina
http://ClinicalTrials.gov/show/NCT00259857
16
All age groups
Aripiprazole and Prolactin Study Phase IV: Single Group Assignment, Efficacy Study NCT01085383
Aripiprazole Hyperprolactinemia Not yet Rec
35 16-25 years
Child Adt
Apr-10 Mar-13 University of Oxford; National Institute for Health Research, United Kingdom
http://ClinicalTrials.gov/show/NCT01085383
Trial of Lithium Carbonate for Treatment of Osteoporosis-pseudoglioma Syndrome Single Group Assignment, Safety/Efficacy Study NCT01108068
Lithium Osteoporosis Pseudoglioma syndrome
Not yet Rec
30 4-64 years
Child Adt
Jul-10 Jul-12 University of Maryland
http://ClinicalTrials.gov/show/NCT01108068
Study of Alendronate Sodium in Juvenile Osteoporosis Single Group Assignment, Safety/Efficacy Study NCT00920075
Alendronate (Fosamax)
Juvenile Osteoporosis; Low Bone Density; Fractures
Invite 25 8-21 years
Child Adt
Jun-09 Sep-10 Medical University of South Carolina; Merck
http://ClinicalTrials.gov/show/NCT00920075
Flixonase Safety in Patients With Allergic Rhinitis (AR) Retrospective, Cohort Study NCT01077609
Intermittent, sub-chronic and chronic Flixonase use; Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase
Rhinitis, Allergic, Perennial; outcomes include proxies for osteoporosis
Active, NR
N/K 4-85 years
Child Adt Sen
Jan-08 Jul-10 GlaxoSmithKline http://ClinicalTrials.gov/show/NCT01077609
Fosamax for Childhood Cancer Survivors Phase III: RCT (active), Efficacy Study NCT00391404
Alendronate; Placebo
Osteoporosis Rec 100 > 15 years
Child Adt Sen
May-06 Oct-08 Chinese University of Hong Kong
http://ClinicalTrials.gov/show/NCT00391404
Bisphosphonate Therapy for Osteogenesis Imperfecta Phase IV: Parallel Assignment, Safety/Efficacy Study NCT00159419
Alendronate; Pamidronate
Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone
Rec 30 3-21 years
Child Adt
Aug-99 Aug-08 Indiana University School of Medicine
http://ClinicalTrials.gov/show/NCT00159419
17
Age group unknown
The role of local glucocorticoid generation in idiopathic osteoporosis UKCRN ID 6204
Glucocorticoids Idiopathic osteoporosis
Comp 75 N/K N/K Oct-09 Queen Elizabeth Hospital, Birmingham
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=6204
No intervention, observational
≤18 years
The Bone-Fat-Pancreas Axis in Children Cross-Sectional, Cohort Study NCT01041898
Bone Mineral Density; Body Fat Distribution; Insulin Homeostasis
Active, NR
32 5-10 years
Child
F-
only
Dec-09 Jun-11 University of Alabama at Birmingham
http://ClinicalTrials.gov/show/NCT01041898
The Role of Impact Activity in Peripubertal Bone Accrual Prospective Cohort study NCT00619047
Bone Mineral Density
Comp 131 10-12 years
Child
F-
only
Jan-02 Aug-08 State University of New York - Upstate Medical University
http://ClinicalTrials.gov/show/NCT00619047
All age groups
Spine Quantitative Computed Tomography (QCT) Cross-sectional, Case Control NCT00762879
Juvenile Idiopathic Arthritis; to assess osteoporosis
Rec 230 5-21 years
Child Adt
Apr-08 Jan-11 Children's Hospital of Philadelphia
http://ClinicalTrials.gov/show/NCT00762879
Evaluation and Treatment of Skeletal Diseases NCT00024804
Bone Disease Rec N/K Any age
Child Adt Sen
Sep-01 Last update Jul-10
National Institute of Dental and Craniofacial Research (NIDCR)
http://ClinicalTrials.gov/show/NCT00024804
18
A1F: (JUVENILE) PAGET’S DISEASE
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
Age groups unknown
Impact on Reducing the Incidence of Low Serum Calcium by Providing Educational Materials on the Need to Take Daily Supplemental Calcium and Vitamin D to Patients With Paget's Disease Treated With Reclast® Phase IV: Single Group Assignment, Safety Study NCT00668200
Reclast® Paget's Disease of the Bone; Hypocalcemia
Rec 300 Child Adt Sen
May-08 Jan-10 Novartis Pharmaceuticals
http://ClinicalTrials.gov/show/NCT00668200
Bisphosphonate Therapy for Osteogenesis Imperfecta Phase IV: Parallel Assignment, Safety/Efficacy Study NCT00159419
Alendronate; Pamidronate
Osteogenesis Imperfecta; Osteoporosis; Paget Disease of Bone
Rec 30 3-21 years
Child Adt
Aug-99 Aug-08 Indiana University School of Medicine
http://ClinicalTrials.gov/show/NCT00159419
A1G: RICKETS & HYPOPHOPHATASIA
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Dietary Supplement
≤18 years
Effects of Vitamin D Dose and Genotype of the Binding Protein in Infants and Children Randomized, Dose Comparison, Safety/Efficacy Study NCT01050387
Vitamin D Vitamin D Deficiency Not yet Rec
120 0.5-6 years
Child
Jan-10 Dec-13 Yale University; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Thrasher Research Fund
http://ClinicalTrials.gov/show/NCT01050387
19
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children RCT (placebo), Safety/Efficacy Study NCT00944606
Vitamin D; Placebo candy
Hypovitaminosis D Not yet Rec
80 5-14 years
Child
Jul-09 Aug-10 University of New Mexico
http://ClinicalTrials.gov/show/NCT00944606
Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips Phase IV: Randomized, Cross-over Study NCT00846677
Dietary Supplement: Vitamin D, cholecalciferol; Dietary Supplement: Vitamin D, cholecalciferol
Healthy Comp 50 < 4 week
s
Child
Jan-09 Sep-09 McGill University http://ClinicalTrials.gov/show/NCT00846677
All age groups
Hypophosphatemic Rickets in Norway Cohort NCT01057186
Alfacalcidol; phosphate
Hypophosphatemia, Familial; Rickets
Rec 80 Child Adt
Dec-09 Dec-12 Haukeland University Hospital
http://ClinicalTrials.gov/show/NCT01057186
Randomised placebo controlled study of vitamin D during pregnancy and infancy RCT (placebo) ACTRN12610000483055
Vitamin D; Placebo Serum 25[OH] vitamin D concentration; hypercalcaemia
Active Child Adt
Jun-10 > Feb-11
University of Auckland; University of Otago
http://www.anzctr.org.au/trial_view.aspx?ID=320842
Drug including biologics
≤18 years
Proton Pump Inhibitor Therapy and Bone Density in Premature Infants Case Control NCT00888017
Proton pump inhibitor therapy; no therapy
Osteopenia; Prematurity
Rec 97 New born (24-36
week gest.)
Child
Apr-09 Apr-11 University of Utah
http://ClinicalTrials.gov/show/NCT00888017
Safety and Efficacy of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP) Phase II: RCT (dose comparison), Safety/Efficacy Study NCT00952484
ENB-0040 Hypophosphatasia Active, NR
12 5-12 years
Child
Sep-09 Jul-10 Enobia Pharma http://ClinicalTrials.gov/show/NCT00952484
20
Safety Study of ENB-0040 in Severely Affected Infants With Hypophosphatasia (HPP) Phase I/II: Single Group Assignment, Safety/Efficacy Study NCT00744042
ENB-0040 Hypophosphatasia Comp 6 ≤36 mth
Child
Sep-08 May-10 Enobia Pharma http://ClinicalTrials.gov/show/NCT00744042
Safety and Efficacy Study of ENB-0040 in Juvenile Patients With Hypophosphatasia (HPP) Phase II: Single Group Assignment (historical), Safety/Efficacy Study NCT00894075
ENB-0040 Hypophosphatasia Wtdwn 8 5-12 years
Child
Jul-09 Apr-10 Enobia Pharma http://ClinicalTrials.gov/show/NCT00894075
Effects of GH on Body Proportions and Final Height in X-Linked Hypophosphatemic Rickets Phase I: RCT (active), Safety/Efficacy Study NCT00473187
Somatropin Hypophosphatemic Rickets; Growth Disorders; Somatropin Therapy
Active, NR
3-10 years
Child
Aug-04 Aug-09 University of Rostock
http://ClinicalTrials.gov/show/NCT00473187
Kabul Vitamin D Supplementation Trial Phase III: RCT (placebo), Efficacy Study NCT00548379
Vitamin D; placebo Pneumonia; Vitamin D Deficiency; incidence of rickets also investigated
Active, NR
3048 1-11 mths
Child
Nov-07 Jul-09 London School of Hygiene and Tropical Medicine; Wellcome Trust; Aga Khan University; Maywand Hospital, Kabul
http://ClinicalTrials.gov/show/NCT00548379
All age groups
Effectiveness of Paricalcitol in Reducing Parathyroid Hormone Levels in X-Linked Hypophosphatemic Rickets Phase III: RCT (placebo), Efficacy Study NCT00417612
Paricalcitol; Placebo Hypophosphatemia, Familial; Hyperparathyroidism
Rec 30 ≥ 9 years
Child Adt Sen
Jan-07 Jan-12 National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
http://ClinicalTrials.gov/show/NCT00417612
Calcimimetics in Hypophosphatemic Rickets Single group assignment, Efficacy Study NCT00844740
Cinacalcet Familial Hypophosphatemic Rickets
Invite 10 5-21 years
Child Adt
Feb-09 Jun-10 Children's Mercy Hospital Kansas City
http://ClinicalTrials.gov/show/NCT00844740
21
Effect of Cinacalcet on Parathyroid Hormone Secretion in Children and Adolescents With Hypophosphatemic Rickets Phase I: Single Group Assignment, Safety/Efficacy Study NCT00195936
Cinacalcet Hypophosphatemic Rickets, X-Linked Dominant
Rec N/K ≥ 5 years
Child Adt Sen
Jun-05 ? Latest update Oct-07
Children's Mercy Hospital Kansas City
http://ClinicalTrials.gov/show/NCT00195936
Age group unknown
Studies With Vitamin D Phase II NCT00001151
1,25-Dihydroxychole-calciferol
Hypocalcemia; Rickets
Comp 200 N/K Mar-76 Oct-09 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
http://ClinicalTrials.gov/show/NCT00001151
No intervention: observational
≤18 years
Utility of a Urine Screening Tool for Vitamin D Deficiency in Infants and Toddlers Cross-sectional,Cohort Study NCT01105689
Vitamin D Deficiency Rec 150 6 mth – 3
years
Child
Mar-10 N/K Nemours Children's Clinic
http://ClinicalTrials.gov/show/NCT01105689
All age groups
Resistance to Vitamin D or Parathyroid Hormone NCT00001242
Hypocalcemia; Osteomalacia; Pseudo-hypoparathyroidism; Pseudopseudo-hypoparathyroidism; Rickets
Rec N/K ≥1 year
Child Adt Sen
Sep-89 Latest update Jul-10
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
http://ClinicalTrials.gov/show/NCT00001242
Serum FGF-23 and Vitamin D Deficiency Prospective, Case Control NCT01102751
Osteomalacia; vitamin D deficiency; hypophosphatemic rickets; healthy
Comp 9-44 years
Child Adt
N/K ? latest update Apr-10
Istanbul University
http://ClinicalTrials.gov/show/NCT01102751
22
A2: DERMATOMYOSITIS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
≤18 years
Phase III Clinical Trials in New Onset Juvenile Dermatomyositis: Steroids Treatment versus Steroids plus Cyclosporine Treatment versus Steroids plus Methotrexate Treatment. RCT (active) NTR667
Steroids; steroids + MTX; steroids + ciclosporin
New onset juvenile dermatomyositis
Active 160 <18 years
Child
Jun-06 Jun-13 N/K http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=667
All age groups
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases Phase IV: Parallel Assignment (active), Safety/Efficacy Study NCT01151644
Anti-pandemic H1N1 influenza vaccine
RA; Spondyloarthritis; SLE; Dermatomyositis (DM); DMixed Connective Tissue Disease; Systemic Vasculitis; Systemic Sclerosis (SSc); Sjögren's Syndrome; Antiphospholipid Syndrome; JIA; Juvenile SLE; Juvenile DM
Active not rec
5000 Child Adt Sen
Apr-10 Dec-10 University of São Paulo; Fundação de Amparo à Pesquisa do Estado de São Paulo
http://ClinicalTrials.gov/show/NCT01151644
23
A3: JUVENILE IDIOPATHIC ARTHRITIS AND JIA-ASSOCIATED UVEITIS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Device
≤18 years
Effect of Functional Treatment on Mandibular Asymmetric Growth Retrospective, Case-Only NCT01113177
Distraction splint therapy
Temporomandibular Joint Disorder; JIA patients with unilateral TMJ arthritis
Rec 35 5-18 years
Child
Jun-94 Dec-10 University of Aarhus; Aarhus University Hospital
http://ClinicalTrials.gov/show/NCT01113177
All age groups
Ultrasound Assessment of Steroid Joint Injections in Juvenile Idiopathic Arthritis Prospective, Case-Only NCT01114243
Ultrasound imaging
Arthritis Not yet rec
75 <21 years
Child Adt
May-10 May-12 Stanford University
http://ClinicalTrials.gov/show/NCT01114243
Use of Thermal and 3D Imaging to Quantify Arthritis Prospective, Cohort Study NCT01044823
Other: 3D and thermal imaging
Rheumatoid Arthritis; Juvenile Rheumatoid Arthritis
Not yet rec
230 Child Adt Sen
Jan-10 Mar-11 University of Pittsburgh; National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
http://ClinicalTrials.gov/show/NCT01044823
Drug including biologics
≤18 years
BeSt for kids: comparing treatment strategies in juvenile idiopathic arthritis. RCT (active) NTR1574
Sulfasalazine, MTX, etanercept; MTX, prednisone, etanercept; etanercept + MTX
JIA Active 180 ? ≤18
years
Jun-09 Jun-13 Leiden University Medical Center
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1574
24
Immunogenicity and duration of immunity in immunosuppressed children vaccinated with Human papillomavirus vaccine Single Group Assignment, Safety/efficacy Study ACTRN12608000260325
HPV vaccine Rheumatic diseases such as SLE and JIA
Active 150 5-18 years
Child
Apr-07 > Apr-12
The Children’s Hospital at Westmead; Center for Infectious Diseases and Microbiology; Women’s and Children’s Hospital, Australia
http://www.anzctr.org.au/trial_view.aspx?ID=82817
VAART-onderzoek (VAccination in ARTritis). RCT NTR1008
MMR booster vaccination
JIA N/K 280 4-8 years
Child
Aug-07 Aug-10 University Medical Center Utrecht; Wilhelmina Children’s Hospital
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1008
Other interventions including CAM
All age groups
Investigation of clinical, serological and genetic factors in the development of arthritis and rheumatic diseases? UKCRN ID 7881
Arthritic and rhematic diseases including reumatoid arthitis, JIA, psoraitic arthitis, systemic sclerosis and chronic pain
Active 8000 Child Adt Sen
N/K Dec-20 University of Manchester; Arthritis Research Campaign
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=7881
No intervention: observational
All age groups
New Candidate Criteria for Diagnosis of Macrophage Activation Syndrome Retrospective, Case-Only NCT01095146
Macrophage Activation Syndrome (MAS); Lymphohistiocytosis, Hemophagocytic. MAS most frequently the result of Systemic onset juvenile idiopathic arthritis
Invite 50 Child Adt Sen
Mar-10 Jan-12 Amrita Institute of Medical Sciences & Research Center
http://ClinicalTrials.gov/show/NCT01095146
25
A4: JUVENILE-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy
All age groups
Iyengar Yoga for Young People With Rheumatoid Arthritis RCT (cross-over), Safety/Efficacy Study NCT01096823
Behavioral: Iyengar Yoga
Rheumatoid Arthritis
Rec 70 16-35 years
Child Adt
Jun-09 May-11 University of California, Los Angeles
http://ClinicalTrials.gov/show/NCT01096823
Drug including biologics
≤18 years
Immunogenicity and duration of immunity in immunosuppressed children vaccinated with Human papillomavirus vaccine Single Group Assignment, Safety/efficacy Study ACTRN12608000260325
HPV vaccine Rheumatic diseases such as SLE and JIA
Active 150 5-18 years
Child
Apr-07 > Apr-12
The Children’s Hospital at Westmead; Center for Infectious Diseases and Microbiology; Women’s and Children’s Hospital, Australia
http://www.anzctr.org.au/trial_view.aspx?ID=82817
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance] Prospective, Cohort Study NCT01145352
Enbrel (etanercept) JIA Rec 300 Child Aug-09 Dec-11 Wyeth http://ClinicalTrials.gov/show/NCT01145352
All age groups
BILAG Biologics Prospective Cohort: The Use of Novel Biological Therapies in the Treatment of Systemic Lupus Erythematosus (SLE) Cohort Study ISCRN ID 8251
Biological agents SLE Active 440 ≥5 years
Child Adt Sen
N/K Oct-15 University of Manchester; Roche Products Limited
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8251
26
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases Phase IV: Parallel Assignment (active), Safety/Efficacy Study NCT01151644
Anti-pandemic H1N1 influenza vaccine
RA; Spondylo-arthritis; SLE; Dermatomyositis (DM); DMixed Connective Tissue Disease; Systemic Vasculitis; Systemic Sclerosis; Sjögren's Syndrome; Antiphospholipid Syndrome; JIA; Juvenile SLE; Juvenile DM
Active not rec
5000 Child Adt Sen
Apr-10 Dec-10 University of São Paulo; Fundação de Amparo à Pesquisa do Estado de São Paulo
http://ClinicalTrials.gov/show/NCT01151644
Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis Phase III: Single Group Assignment, Safety/Efficacy Study NCT01042457
Mycophenolate mofetil
Lupus Nephritis Rec 30 16-60 years
Child Adt
Jun-08 Jun-10 Chulalongkorn University
http://ClinicalTrials.gov/show/NCT01042457
Other interventions including CAM
All age groups
Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment Propsective, Case-Only NCT01060410
Genetic: Polymorphism Analysis; Drug: Cyclophosphamide; Other: Pharmacokinetic analysis
SLE; Adverse Effects
Rec 100 Child Adt Sen
May-10 Jun-12 Sun Yat-sen University; First Affiliated Hospital, Sun Yet-Sen University
http://ClinicalTrials.gov/show/NCT01060410
Age groups unknown
Functional consequences of disease susceptibility genes in Systemic Lupus Erythematosus (SLE)
Genetic: polymorphism analysis
SLE Active 200 N/K N/K May-18 Hammersmith Hospital; Imperial College London
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4827
27
No intervention, observational
All age groups
Autoimmunity in Sisters of Lupus Patients Prospective, Family-Based NCT01076101
SLE Rec 800 ≥10-≤35
years
Child Adt
F-
only
Dec-09 Dec-11 North Shore Long Island Jewish Health System; National Institute of Allergy and Infectious Diseases
http://ClinicalTrials.gov/show/NCT01076101
Age groups unknown
Validation of BILAG2004 index for assessment of disease activity in systemic lupus erythematosus (SLE) UKCRN IN 2869
SLE Active 250 ? ≥16
years
N/K Jul-12 University of Birmingham; Arthritis Research Campaign
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=2869
28
A5: NON-INFLAMMATORY
A5A: CHRONIC PAIN SYNDROME, COMPLEX REGIONAL PAIN SYNDROME & FIBROMYALGIA
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Behavioural, education & exercise including physiotherapy
≤18 years
Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents RCT, Efficacy Study NCT01118988
Mentorship Irritable Bowel Syndrome; Functional Abdominal Pain; Fibromyalgia; Complex Regional Pain Syndrome; Myofacial Pain; Chronic Daily Headaches; Migraine Headaches; Chronic Pain
Rec 56 12-18 years
Dec-09 Apr-11 University of California, Los Angeles
http://ClinicalTrials.gov/show/NCT01118988
Coping Skills Training for Adolescents With Fibromyalgia Phase III: RCT (active), Efficacy Study NCT00086047
Coping Skills Training; Education
Fibromyalgia Rec 116 11-18 years
Jul-04 Dec-09 National Institute of Arthritis and Musculoskeletal and Skin Diseases
http://ClinicalTrials.gov/show/NCT00086047
Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population Parallel Assignment, Efficacy Study NCT00909194
Psycho-educational Seminar and Relaxation Technique
Juvenile Primary Fibromyalgia Syndrome
Comp 132 12-18 years
F-
only
Jul-07 Dec-08 University of Kentucky
http://ClinicalTrials.gov/show/NCT00909194
Qigong vs. Aerobic Exercise in the Treatment of Childhood Chronic Musculoskeletal Pain Phase II: RCT (active), Safety/Efficacy Study NCT00312234
Aerobic exercise; Qigong exercise
Muscular Disease; Fibromyalgia
Rec 30 8-18 years
Aug-05 The Hospital for Sick Children
http://ClinicalTrials.gov/show/NCT00312234
All age groups
A randomised controlled trial of a brief walking intervention. RCT ISRCTN95932902
Brief walking intervention (including education, pedometer); usual care
Chronic conditions where activity shown to have positive effect including fibromyalgia and osteoporosis
Active 400 16-65 Years
Child Adt
Dec-09 May-11 Coventry University
http://www.controlled-trials.com/ISRCTN95932902
29
Age group unknown
Guided imagery in patients with fibromyalgia. RCT (active) NTR2172
Guided imagery; group conversation
Fibromyalgia Active 70 N/K Nov-09 Dec-10 Fonds NutsOhra http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2172
Drug including biologics
≤18 years
A Study for Adolescents With Fibromyalgia Syndrome Phase IV: Single Group Assignment NCT01089621
Duloxetine Fibromyalgia Susp 20 13-17 years
Child
Mar-10 May-14 Eli Lilly and Company
http://ClinicalTrials.gov/show/NCT01089621
Pregabalin In Adolescent Patients With Fibromyalgia Phase IV: Single Group Assignment, Safety Study NCT01020526
Pregabalin Fibromyalgia Not yet Rec
162 12-18 years
Child Adt
Jul-10 Sep-13 Pfizer http://ClinicalTrials.gov/show/NCT01020526
Adolescent Fibromyalgia Study Phase IV: RCT (placebo), Safety/Efficacy Study NCT01020474
Pregabalin; Placebo
Fibromyalgia Rec 162 12-16 years
Child
Apr-10 Jan-13 Pfizer http://ClinicalTrials.gov/show/NCT01020474
Low Dose Naltrexone for the Treatment of Juvenile Primary Fibromyalgia Syndrome Single Group Assignment, Safety/Efficacy Study NCT00855972
Low Dose Naltrexone
Fibromyalgia Wtdwn 40 7-17 years
Child
Aug-10 Dec-11 Stanford University
http://ClinicalTrials.gov/show/NCT00855972
The Norwegian Study of Chronic Fatigue Syndrome in Adolescents: Pathophysiology and Intervention Trial Phase II: RCT (placebo), Efficacy Study NCT01040429
Clonidine; Lactose capsula
Chronic Fatigue Syndrome; Myalgic Encephalomyelitis
Rec 120 12-18 years
Child Adt
Feb-10 Aug-11 Oslo University Hospital
http://ClinicalTrials.gov/show/NCT01040429
Clinical Trial Testing the Safety and Efficacy of Fluoxetine in Juvenile Fibromyalgia Phase III: Single Group Assignment, Safety/Efficacy Study NCT00115804
Fluoxetine Juvenile Primary Fibromyalgia Syndrome (JPFS); Fibromyalgia
Active, NR
15 13-18 years
Child Adt
Jun-05 Jun-10 University of Cincinnati; Arnold, Lesley, M., M.D.
http://ClinicalTrials.gov/show/NCT00115804
30
Clinical response to intravenous immunoglobulin inpatients with complex regional pain syndrome (CRPS) RCT (placebo) ISRCTN63918259
Immunoglobulin IV; placebo
CRPS Comp 16 ≥16 years
Child Adt
Nov-05 Aug-08 Department of Health, UK.
http://www.controlled-trials.com/ISRCTN63918259
A Study on Health - Related Quality of Life in Patients With Rheumatic Diseases Taking Tramadol 37.5mg/Acetaminophen 325mg Tablets NCT00642837
Tramadol/acetaminophen
Rheumatic Diseases including Complex Regional Pain Syndrome
Comp 982 ≥12 years
Child Adt Sen
Sep-07 May-08 Janssen Korea, Ltd., Korea
http://ClinicalTrials.gov/show/NCT00642837
Age group unknown
Double-blind randomised placebo-controlled cross-over study to investigate the effectiveness of intramuscular magnesium on pain and dystonia in Complex Regional Pain Syndrome type 1. RCT (placebo) NTR1873
Intramuscular magnesium sulphate
Complex regional pain syndrome type 1; Dystonia
Active 40 N/K Jul-09 Oct-10 Leiden University Medical Center
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1873
Pharmacokinetic-pharmacodynamic modeling of S(+)-ketamine in fibromyalgia RCT (active) NTR1343
S(+) –ketamine Fibromyalgia Comp 24 N/K Feb-10 Jul-10 Leiden University Medical Center
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1343
Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia Phase IV: RCT (placebo), Efficacy Study NCT01014585
Milnacipran; Placebo
Fibromyalgia Comp 425 N/K Nov-09 May-10 Forest Laboratories; Cypress Bioscience, Inc.
http://ClinicalTrials.gov/show/NCT01014585
The influence of different flow rates of intrathecal baclofen infusion on dystonia and pain in Complex Regional Pain Syndrome type 1 RCT (active) NTR1269
Intrathecal baclofen infusion
Complex regional pain syndrome 1; Dystonia
Comp 14 N/K Apr-08 Oct-08 Leiden University Medical Center
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1269
31
Other interventions including CAM
≤18 years
Effectiveness and cost-analysis of a three-week multimodal inpatient pain treatment for children and adolescents suffering from chronic pain RCT ISRCTN91385238
Multimodal inpatient pain program (including CBT, physiotherapy, music therapy)
Chronic pain (CRPS excluded)
Active 120 9-18 years
Child
Nov-09 Nov-11 Vodafone Foundation Institute, Germany
http://www.controlled-trials.com/ISRCTN91385238
No intervention, observational
All age groups
A Prevalence Study of Chronic Widespread Pain (CWP) Among Patients With Rheumatoid Arthritis (RA) and Control Population in Tallinn and Harjumaa County Cross-sectional, Case Control Study NCT00721318
Chronic Widespread Pain Active, NR
6000 ≥16 years
Child Adt Sen
May-08 May-10 Estonian Society for Rheumatology
http://ClinicalTrials.gov/show/NCT00721318
Genetics of Fibromyalgia Retrospective, Family-Based Study NCT00071162
Fibromyalgia; Irritable Bowel Syndrome; Chronic Fatigue Syndrome; Depression
Active, NR
560 ≥12 years
Child Adt Sen
Sep-99 ? Last
update Mar-09
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
http://ClinicalTrials.gov/show/NCT00071162
32
A5B: HYPERMOBILITY, JOINT HYPERMOBILITY SYNDROME & EHLERS-DANLOS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
All age groups
Celiprolol in Patients With Ehlers-Danlos Syndrome, Vascular Type Phase III: RCT (active), Efficacy Study NCT00190411
Celiprolol Ehlers-Danlos Syndrome (Type IV, Autosomal Dominant); Gene Map Locus 2q31
Active, NR
100 15-65 years
Child Adt
Oct-03 Oct-10 Assistance Publique - Hôpitaux de Paris; Aventis Pharmaceuticals
http://ClinicalTrials.gov/show/NCT00190411
No intervention, observational
≤18 years
The Clinical Characteristics of Children with Generalised Joint Hypermobility and thier Relationship to Adverse Outcomes ACTRN12610000054011
Joint Hypermobility; Ehlers-Danlos Syndrome
Active 150 6-18 years
Child
Mar-07 > Mar-12
Children’s Hospital at Westmead, Australia
http://www.anzctr.org.au/trial_view.aspx?ID=334991
All age groups
Manifestations of Heritable Disorders of Connective Tissue Prospective, Cohort Study NCT00270686
Ehlers-Danlos Syndrome; Marfan Syndrome; Stickler Syndrome
Rec 300 ≥12 years
Child Adt Sen
Jun-03 Dec-12 National Institute on Aging (NIA)
http://ClinicalTrials.gov/show/NCT00270686
Is joint hypermobility a risk factor for the deployment of chronic musculoskeletal pain in adolescence? UKCRN ID 5880
Joint hypermobility Active 5000 N/K N/K Apr-10 University of Bristol
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=5880
33
A6: SCLERODERMA
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
All age groups
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases Phase IV: Parallel Assignment (active), Safety/Efficacy Study NCT01151644
Anti-pandemic H1N1 influenza vaccine
RA; Spondyloarthritis; SLE; Dermatomyositis (DM); DMixed Connective Tissue Disease; Systemic Vasculitis; Systemic Sclerosis (SSc); Sjögren's Syndrome; Antiphospholipid Syndrome; JIA; Juvenile SLE; Juvenile DM
Active not rec
5000 Child Adt Sen
Apr-10 Dec-10 University of São Paulo; Fundação de Amparo à Pesquisa do Estado de São Paulo
http://ClinicalTrials.gov/show/NCT01151644
34
A7: VASCULITIS
Title Phases: trial design (control) CT ID
Interventions Conditions Recruit n Age (Grp)
Start Date
End Date
Sponsors URL
Drug including biologics
All age groups
Plasma Exchange and Glucocorticoid Dosing in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial UKCRN ID 8278
Plasma exchange + glucocorticoid
ANCA associated vasculitis
Active 500 ≥15 years
Child Adt Sen
N/K Jan-17 Addenbrooke’s Hospital
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=8278
Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases Phase IV: Parallel Assignment (active), Safety/Efficacy Study NCT01151644
Anti-pandemic H1N1 influenza vaccine
RA; Spondyloarthritis; SLE; Dermatomyositis (DM); DMixed Connective Tissue Disease; Systemic Vasculitis; Systemic Sclerosis (SSc); Sjögren's Syndrome; Antiphospholipid Syndrome; JIA; Juvenile SLE; Juvenile DM
Active not rec
5000 Child Adt Sen
Apr-10 Dec-10 University of São Paulo; Fundação de Amparo à Pesquisa do Estado de São Paulo
http://ClinicalTrials.gov/show/NCT01151644
A randomised clinical trial of mycophenolate mofetil versus cyclophosphamide for remission induction in ANCA associated vasculitis RCT (active) ISRCTN15366107
Mycophenolate mofetil; cyclophosphamide
ANCA associated vasculitis; Wegener’s Granulomatosis; microscopic polyangiitis
Comp 140 ≥5 years
Child Adt Sen
Mar-07 Jan-10 Cambridge University Hospitals NHS Foundation Trust (UK)
http://www.controlled-trials.com/ISRCTN15366107
Age groups unknown
The use of abatacept in ANCA associated vasculitis Phase II/III UKCRN ID 5785
Abatacept ANCA associated vasculitis
Comp 112 N/K N/K Jun-08 Addenbrooke’s Hospital, UK; Bristol Myers Squibb
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=5785
35
Other interventions including CAM
All age groups
Research on the Blood- Cooling - Toxin - Removing - Stasis - Dispersing Protocol Evaluation of Hench-schonlein Purpura Phase II: RCT (placebo), Efficacy Study NCT01104428
TCM: “Ziying" granules; Placebo
Purpura, Schoenlein-Henoch
Rec 256 Child Adt
Nov-09 Dec-11 Liaoning University of Traditional Chinese Medicine
http://ClinicalTrials.gov/show/NCT01104428
No intervention, observational
All age groups
Canterbury anti-neutropil cytoplasmic antibody (ANCA) associated vasculitis observational study Longitudinal, Natural History Study ACTRN12608000012370
ANCA associated vasculiitis; Wegeners granulomatosis
Ongoing 75 Child Adt Sen
Jan-08 N/K University of Otago; Canterbury Health Laboratories
http://www.anzctr.org.au/trial_view.aspx?ID=82497
Age groups unknown
Investigation of the Role of Complementary Proteinase 3 in the Development of PR3-ANCA-Associated Vasculitis UKCRN ID 4141
PR3-ANCA-associated vasculitis
Comp 90 N/K N/K Feb-09 University of Birmingham
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=4141
Endothelia injury and repair in vasculitis of the young UKCRN ID 6428
Vasculitis Active 150 N/K N/K Aug-10 Institute of Child Health; Arthritis Research Campaign; Nuffield Foundation
http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=6428