A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Adult patients, ≥ 18 years of age

• Confirmed moderate or severe rheumatoid arthritis

• Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)

Exclusion Criteria:

• Presence of infectious diseases [tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C]

• Inadequate hematologic, renal or liver function

• Peptic ulcer disease (in acute phase)

• Pregnant and lactating women