A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF

• Status: Completed
• Trial end date: 2013-05-12
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single arm study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF. Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (max 800 mg) intravenously every 4 weeks for a total of 6 infusions. Non-biologic DMARD therapy may be continued throughout the study. Anticipated time on study treatment is 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Active moderate to severe rheumatoid arthritis of >/= 6 months duration

• >/=1 non-biologic DMARD and/or anti-TNF therapy at stable dose for >/=8 weeks at any time prior to study treatment

• Inadequate clinical response to non-biologic DMARD or anti-TNF therapy

• Oral corticosteroids must be at stable dose for at least 25 out of 28 days prior to first dose of study drug

Exclusion Criteria:

• Pregnant or lactating women

• Major surgery (including joint surgery) within 8 weeks prior to screening or major surgery planned within 6 months of enrolment

• Rheumatic autoimmune disease other than RA

• Functional class IV (ACR classification)

• Prior history of or current joint disease other than RA

• Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline

• Previous treatment with RoActemra/Actemra

• Known active current or history of recurrent infection

• History of or currently active primary or secondary immunodeficiency

• Active tuberculosis requiring treatment within the previous 3 years

• Positive for HIV