Overview

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)

Status:
Completed
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
This open-label, single arm study will assess the safety and efficacy of RoActem ra/Actemra (tocilizumab) in combination with methotrexate in patients with activ e moderate to severe rheumatoid arthritis who have an inadequate response to dis ease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Act emra at a dose of 8 mg/kg (maximum 800 mg) intravenously every 4 weeks for a tot al of 6 infusions. Methotrexate will be continued at a stable dose. Anticipated time on study treatment is 24 weeks.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Antirheumatic Agents
Methotrexate
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 equivalent) for at least 25 out of 28 days prior to first dose of study drug

- Body weight
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