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Current Studies

Clinical trials are vital in developing and evaluating new treatments for children with rheumatologic diseases.

Studies currently being conducted by the PRCSG include:

Title	Sponsor

A randomized, double-blind, placebo controlled, single-dose study to assess the initial efficacy of canakinumab (ACZ885) with respect to the adapted ACR Pediatric 30 criteria in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestation	Novartis

A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations	Novartis

An open label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestation	Novartis

A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	Hoffman-La Roche, LTD

Compassionate Use Study of Adalimumab in Children 2 to <4 Years Old or Age 4 and Above Weighing Less than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)	Abbott

A Long-term, Multicenter, Longitudinal Post-marketing, Observational Registry of Humira (adalimumab) in Children with Active Juvneile Idiopathic Arthritis (JIA)	Abbott

SINCERE™: Safety in Idiopathic Arthritis: NSAIDs and Celebrex Evaluation Registry A Prospective Observational Registry Of Patients With Juvenile Idiopathic Arthritis (JIA) Treated With NSAIDs	Pfizer
A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis, With an Open-Label Extension to Examine the Long Term Use of Tocilizumab	Hoffman- La Roche, LTD
A Phase III, Multi-Center, Multi-National, Randomized Withdrawal Study to Evaluate the Safety and Efficacy of BMS-188667 in Children and Adolescents With Active Polyarticular Juvenile Rheumatoid Arthritis (JRA)	Bristol-Myers Squibb
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis	Abbott
For a comprehensive list of all rheumatology studies, click here

Completed Studies

Years	Title
2000-2008	Phase IV Registry of etanercept (Enbrel) in children with Juvenile Rheumatoid Arthritis. Data submitted for publication

2005-2008	A Pilot, Multi-Center, Randomized, Double Blind, Placebo Controlled, Ascending Dose, Safety, Tolerability and Preiminary Efficacy Study of Two Dose Levels of IL-1 Trap Administered Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)

2002-2004	Clinical Protocol for a Randomized, Double-blind Multi-center, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients with JRA

2002-2003	Efficacy and Safety of Leflunomide versus Methorexate Comparison in Patients with Juvenile Rheumatoid Arthritis (JRA)

2001-2003	A Randomized, Double-blind Trial of Anti-TNF alpha Chimeric Monoclonal Antibody (INFLIXIMAB) in Combination with Methotrexate for the Treatment of Patients with Polyarticular JRA

2001-	A 52-Week, Open Label, Active Comparator Controlled Extension to a 12-Week Trial of Rofecoxib in Juvenile Rheumatoid Arthritis Patients

2000-	A 12-Week Double-Blind Randomized Trial, With a 12-Week Open Label Extension, to Investigate Efficacy and Safety of Meloxicam Oral Suspension Administered Once Daily and Naproxen Oral Suspension Administered Twice Daily in Children With JRA.

2000-	Safety and Efficacy of Meloxicam Oral Suspension in JRA (Subtrial of 107.208)

2000-2003	Development and Validation of Core Sets of Outcome Measures and Definitions of Improvement for Juvenile Dermatomyositis and Juvenile Systemic Lupus Erythematosus

2000-2003	A Randomized, Multi-center, Blinded, Placebo-controlled Study with an Open Label Run-in Period to Evaluate the Efficacy, Safety & Pharmacokinetics of Daily, Single, Subcutaneous Injections of r-metHUlL-Ira (Anakinra) in Polyarticular Course JRA

2000-2003	A Companion Extension Study to Evaluate the Long-term Safety of Daily, Single, Subcutaneous injections of r-metHulL-1ra (Anakinra) in Subjects with Polyarticular Course JRA who participated in IL-1ra (Protocol 990758)

1999-	An Open, Oral Dose Study to Evaluate the Steady State Plasma Concentration Profile of MK-0966, Followed by a 12-Week, Double-blind, Active-comparator-controlled Extension, in Late- and Post-pubertal Adolescents With Juvenile Rheumatoid Arthritis

1999-2000	Therapeutic Exploratory Trial of Cosamin DS in JRA

1999-2002	Neoral in Polyarticular Course JRA: Post-marketing Surveillance

1998-2000	Parenteral Methotrexate in Medium versus High-dosed for the Treatment of Idiopathic Arthritis of Childhood

1998-1999	Phase I Trial - Leflunomide in Poly course JRA

1997-1998	Safety, Population PK and Efficacy of Recombinant Human Tumor Necrosis Factor Receptor (P75) Fc Fusion Protein (TNFR:Fc) in Children with JRA

1997-	Open-label Treatment with TNFR:Fc in JRA

1995-1996	A Double-blind, Randomized, Vehicle-controlled, Parallel Group Multi-center Pilot Study Evaluating the Safety and Efficacy of Civamide Cream, 0.075% in Children with Pauciarticular Juvenile Rheumatoid Arthritis Disease of the Knee

1994-1996	Phase I/II study of DAB389IL-2 Fusion Toxin in Patients with Severe Polyarticular Juvenile Rheumatoid Arthritis

1992-1996	Intravenous Gammaglobulin (IVEEGAM) in Polyarticular Juvenile Rheumatoid Arthritis

1990-1992	Intravenous Gammaglobulin in Severe Polyarticular JRA Patients