A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Juvenile Idiopathic Arthritis

In brief

This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

Key facts

Study ID

NCT00988221

Run by

Hoffmann-La Roche

People needed

188

Starts

2009-11-30

Expected to finish

2013-01-28

Last updated by the study team

2017-07-26

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children/juveniles, 2-17 years of age.
• Polyarticular-course juvenile idiopathic arthritis (pcJIA) ≥ 6 months duration.
• Active disease (≥ 5 active joints, ≥ 3 with limitation of motion).
• Inadequate response to or inability to tolerate methotrexate.
• Methotrexate, oral corticosteroids, and non-steroidal anti-inflammatory drugs (NSAID) at stable dose(at least 8, 4, and 2 weeks,respectively) prior to baseline.
• Biologics discontinued, between at least 1 and 20 weeks prior to baseline, depending on biologic.

You may not qualify if…

• Auto-immune, rheumatic disease or overlap syndrome other than pcJIA.
• Wheelchair bound or bedridden.
• Intra-articular, intramuscular, intravenous, or long-acting corticosteroids within 4 weeks prior to baseline.
• Disease-modifying anti-rheumatic drugs (DMARD) (other than methotrexate) within 4 weeks prior to baseline.
• Previous treatment with tocilizumab.

Where it is running

• Children's National Medical Center; Pediatric Rheumatology — Washington D.C., District of Columbia, United States
• Delray Research Associates — Delray Beach, Florida, United States
• Miami Children's Hospital — Miami, Florida, United States
• The University of Chicago;Department of Pediatrics — Chicago, Illinois, United States
• University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• Children's Hospital — New Orleans, Louisiana, United States
• Hackensack University Medical Center; Pediatric Rheumatology — Hackensack, New Jersey, United States
• Cincinnati Children'S Hospital Medical Center; Division of Rheumatology — Cincinnati, Ohio, United States
• Healthcare Research Consultants — Tulsa, Oklahoma, United States
• Hospital Gral de Niños Pedro Elizalde — Buenos Aires, Argentina
• Hospital de Niños; Reumatologia — Buenos Aires, Argentina
• Caici; Rheumatology — Rosario, Argentina
• Centro Medico Privado de Reumatologia; Reumathology — San Miguel, Argentina
• Westmead Hospital; Paediatric Rheumatology — Westmead, New South Wales, Australia
• Royal Children'S Hospital; Paediatric Rheumatology — Parkville, Victoria, Australia
• Princess Margaret Children'S Hospital; Department of Immunology — Subiaco, Western Australia, Australia
• UZ Gent — Ghent, Belgium
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Hospital Universitario Pedro Ernesto; Nucleo de Estudos da Saude do Adolescente — Rio de Janeiro, Rio de Janeiro, Brazil
• Instituto de Puericultura E Pediatria Martagão Gesteira — Rio de Janeiro, Rio de Janeiro, Brazil
• Hospital das Clinicas - UFRGS — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia — São Paulo, São Paulo, Brazil
• Alberta Children'S Hospital — Calgary, Alberta, Canada
• British Columbia Children's Hospital; Rheumatology — Vancouver, British Columbia, Canada
• Connecticut Children's Medical Center; 5E Clinical Trials Unit — Hartford, Connecticut, United States

Full record on ClinicalTrials.gov

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