A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis
NCT00721123 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 538
Last updated 2013-11-28
Summary
This open-label, international multi-center extension study WA18695 was designed to assess the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.
Conditions
Interventions
- DRUG
-
Tocilizumab (myeloma receptor antibody \[MRA\]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2012-05-31
- Completion
- 2012-05-31
Countries
- Argentina
- Australia
- Austria
- Brazil
- Bulgaria
- Canada
- France
- Germany
- Hong Kong
- Hungary
- Israel
- Italy
- Mexico
- Singapore
- Slovakia
- Switzerland
- Thailand
Study Locations
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