Clinical trial NCT01194414
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Start date: 2010-09-01; Completion date: 2013-08-01
Enrollment: 1262 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.

Detailed description:

Arms: arm 1: Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.

Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. arm 2: Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.

Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. arm 3: Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.

Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study. arm 4: Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.

Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study.
Interventions: intervention 1: tocilizumab SC intervention 2: tocilizumab IV intervention 3: placebo to tocilizumab SC intervention 4: placebo to tocilizumab IV intervention 5: Disease-modifying antirheumatic drugs (DMARDs)
Intervention descriptions: intervention 1: Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week. intervention 2: Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks. intervention 3: Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period. intervention 4: Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period. intervention 5: stable dose as prescribed

Protocol documents: