Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP
- Sponsor
- Chugai Pharmaceutical
- Study ID
- NCT00144586
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- MRA(Tocilizumab) — DRUG8mg/kg/4 weeks
Study Details
This is an open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who participated in Study MRA220JP or MRA221JP.
Key Dates
- Start date
- Mar 31, 2005
- Status verified
- Aug 2013
- Primary completion
- Aug 31, 2008
- Completion
- Jun 30, 2009
Study Design
- Enrollment
- 42 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
Primary Outcome Measure
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study. [ Time Frame: throughout study ]
Related Studies
- CorEvitas Rheumatoid Arthritis (RA) Drug Safety & Effectiveness RegistryEnrolling By Invitation · CorEvitas · Waltham, Massachusetts
- Physica System Total Knee Replacement Registry StudyRecruiting · Limacorporate S.p.a · Rancho Mirage, California
- Early Rheumatoid Arthritis Lung Disease StudyRecruiting · University of Nebraska · Omaha, Nebraska
- Maternal Autoimmune Disease Research Alliance (MADRA) RegistryRecruiting · Duke University · Durham, North Carolina