A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)

Launched by HOFFMANN-LA ROCHE · Nov 4, 2010

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients, \>/= 18 years of age
• • Active moderate to severe rheumatoid arthritis (RA)
• • On methotrexate treatment (oral or parenteral) for at least 12 weeks, at stable dose of at least 15 mg/week for at least 6 weeks
• • Oral corticosteroids must have been at stable dose of \</= 10 mg/day prednisone (or equivalent) for at least 25 out of 28 days prior to first dose of study drug
• • Body weight \</= 150 kg
• Exclusion Criteria:
• • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months of study entry
• • Rheumatic autoimmune disease other than RA
• • Functional class IV according to American College of Rheumatology (ACR) classification
• • Prior history of or current inflammatory joint disease other then RA
• • Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
• • Treatment with any biologic drug that is used in the treatment or RA
• • Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
• • Known active current or history of recurrent infection
• • History of or currently active primary or secondary immunodeficiency
• • Positive for HIV