horizon scanning p upate july 2010 - keele university€¦ · 6 studies with vitamin d phase ii...

© Arthritis Research UK 2010

1

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

2

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.

3

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.

4

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/NCT00744302


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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)


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)


Studies of Elevated Parathyroid Activity NCT00001277

Hyperparathyroidism; Hypocalcemia; Hypoparathyroidism; Parathyroid Neoplasm

Rec N/K Child Adt Sen

Mar-91 ? Last

update Jul-10



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



A1B: DYSPLASIA & MCCUNE ALBRIGHT SYNDROME



Start Date

End Date

Sponsors URL


≤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






7

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


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)


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






8

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


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)


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)


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









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A1C: OSTEOGENESIS IMPERFECTA



Start Date

End Date

Sponsors URL


≤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


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


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


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)


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






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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


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



≤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


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)


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)








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A1D: OSTEOPETROSIS



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



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


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


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


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


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


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






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A1E: OSTEOPOROSIS



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


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)


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


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


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


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



≤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





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


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


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


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


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









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


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


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


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





Rec 30 3-21 years

Child Adt









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



≤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


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


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


Evaluation and Treatment of Skeletal Diseases NCT00024804

Bone Disease Rec N/K Any age

Child Adt Sen

Sep-01 Last update Jul-10









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A1F: (JUVENILE) PAGET’S DISEASE



Start Date

End Date

Sponsors URL


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





Rec 30 3-21 years

Child Adt



A1G: RICKETS & HYPOPHOPHATASIA



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





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


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


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



≤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


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


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


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)


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








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


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)



≤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


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



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







22

A2: DERMATOMYOSITIS



Start Date

End Date

Sponsors URL


≤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://www.trialregister.nl/trialreg/admin/rctview.asp?TC=667



23

A3: JUVENILE IDIOPATHIC ARTHRITIS AND JIA-ASSOCIATED UVEITIS



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


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


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)



≤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







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


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



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



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









25

A4: JUVENILE-ONSET SYSTEMIC LUPUS ERYTHEMATOSUS



Start Date

End Date

Sponsors URL


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



≤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


Child

Apr-07 > Apr-12

The Children’s Hospital at Westmead; Center for Infectious Diseases and Microbiology; Women’s and Children’s Hospital, Australia


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








26



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



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



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


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







27


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


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





28

A5: NON-INFLAMMATORY

A5A: CHRONIC PAIN SYNDROME, COMPLEX REGIONAL PAIN SYNDROME & FIBROMYALGIA



Start Date

End Date

Sponsors URL


≤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


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


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


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


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








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


≤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


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


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


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.










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.


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


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


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


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.


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












31


≤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)


Child

Nov-09 Nov-11 Vodafone Foundation Institute, Germany



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


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)






32

A5B: HYPERMOBILITY, JOINT HYPERMOBILITY SYNDROME & EHLERS-DANLOS



Start Date

End Date

Sponsors URL


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



≤18 years

The Clinical Characteristics of Children with Generalised Joint Hypermobility and thier Relationship to Adverse Outcomes ACTRN12610000054011

Joint Hypermobility; Ehlers-Danlos Syndrome


Child

Mar-07 > Mar-12

Children’s Hospital at Westmead, Australia


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)


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








33

A6: SCLERODERMA



Start Date

End Date

Sponsors URL


All age groups




Active not rec

5000 Child Adt Sen




34

A7: VASCULITIS



Start Date

End Date

Sponsors URL


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





Active not rec

5000 Child Adt Sen



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)


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









35


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



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


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


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









horizon scanning p upate july 2010 - keele university€¦ · 6 studies with vitamin d phase ii...

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