A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage

Launched by HOFFMANN-LA ROCHE · Aug 7, 2012

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients, \>/= 18 years of age
• • Active severe rheumatoid arthritis (DAS28 \> 5.1) according to European League of Rheumatism (EULAR)/American College of Rheumatology (ACR) criteria
• • Inadequate response to a trial of 2 DMARDs, including methotrexate, a trial being defined as 6 months with 2 months at standard dose; no previous treatment with a biologic agent such as a tumor necrosis factor (TNF) inhibitor
• • Oral corticosteroids must have been at a stable dose of \</= 10 mg/day prednisolone or equivalent for at least 25 out of 28 days prior to start of treatment (Day 1)
• Exclusion Criteria:
• • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
• • Rheumatic autoimmune disease other than rheumatoid arthritis
• • Functional class IV as defined by the ACR Classification of Functional Status in RA
• • Prior history of or current inflammatory joint disease other than RA
• • Previous treatment with tocilizumab
• • Previous treatment with any biologic drug (e.g. TNF inhibitor) that is used in the treatment of RA
• • Intraarticular or parenteral corticosteroids within 6 weeks prior to enrollment
• • Inadequate liver, bone marrow or hepatic function
• • Positive for hepatitis B, hepatitis C or HIV infection
• • Pregnant or breastfeeding women
• • Females of child-bearing potential who are not using reliable means of contraception
• • History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies
• • Active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
• • History of, or currently active, primary or secondary immunodeficiency