Conditions: Rheumatoid Arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 103
Healthy volunteers: no

Brief summary:
This study will assess the onset and maintenance of effect of tocilizumab on relief in patients with active moderate or severe rheumatoid arthritis who have had an inadequate response to DMARDs or anti-TNF. For the first, double-blind, part of the study patients will be randomized to receive an iv infusion of either 8mg/kg tocilizumab or placebo. After 4 weeks this will be followed by 11 months treatment with tocilizumab 8mg/kg iv infusion every 4 weeks. Methotrexate or DMARD therapy will be continued throughout study treatment. Target sample size is \>100.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: placebo intervention 3: tocilizumab [RoActemra/Actemra]
Intervention descriptions: intervention 1: single iv infusion 8 mg/kg intervention 2: single iv infusion intervention 3: iv infusion 8mg/kg every 4 weeks for 11 months

Protocol document: