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

Roche

Status and phase: Completed; Phase 3

Conditions: Juvenile Idiopathic Arthritis

Treatments: Drug: Tocilizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00988221

2009-011593-15 (EudraCT Number)

WA19977

Details and patient eligibility

About

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.

Enrollment: 188 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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188 participants in 4 patient groups, including a placebo group

Tocilizumab 10 mg/kg in patients weighing < 30 kg

Experimental group

Description:

Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.

Treatment:

Drug: Tocilizumab

Tocilizumab 8 mg/kg in patients weighing < 30 kg

Experimental group

Description:

Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.

Treatment:

Drug: Tocilizumab

Tocilizumab 8 mg/kg in patients weighing ≥ 30 kg

Experimental group

Description:

Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.

Treatment:

Drug: Tocilizumab

Placebo

Placebo Comparator group

Description:

Patients received placebo to tocilizumab intravenously every 4 weeks.

Treatment:

Drug: Placebo