A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: rituximab [MabThera/Rituxan]

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01332994

ML22985

Details and patient eligibility

About

This open-label, multi-center, two-arm, uncontrolled and non-randomized study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks for 12 weeks and - if adequately responded - for further 12 weeks. Patients, who show an inadequate clinical response after the first 12 weeks to RoActemra/Actemra, will receive 1 g MabThera/Rituxan (rituximab) intravenously at Week 16 and 18. The anticipated time of study treatment is 32 weeks.

Enrollment

519 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients >/=18 years of age
Body weight < /=130kg
Active rheumatoid arthritis of at least 6 months duration, diagnosed according to the American College of Rheumatology (ACR) criteria of 1987
Disease Activity Score (DAS28) of >3.2
Inadequate clinical response to a stable dose of traditional Disease-Modifying Anti-Rheumatic Drugs (DMARD)
Have received permitted DMARDs, one or more; current DMARD therapy must have been at stable dose for at least 4 weeks prior to baseline

Exclusion criteria

Prior treatment with TNF-inhibitors or other biologic DMARD
Major surgery (including joint surgery) within eight weeks prior to baseline or planned major surgery within the study duration
Functional class IV (American College of Rheumatology classification)
Rheumatic autoimmune disease other than rheumatoid arthritis
History of or current inflammatory joint disease other than rheumatoid arthritis