Study of MRA in Patients With Rheumatoid Arthritis (RA)
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: MRA(Tocilizumab)
- Registration Number
- NCT00144651
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
This is an open-label, extension, Phase II study to evaluate the long-term safety and efficacy of MRA in Patients with RA who were participated in Study MRA009JP.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 135
Inclusion Criteria
- Patients administered MRA more than 2 times in preceding study, MRA009JP, and evaluated the efficacy and the safety.
- Patients confirmed to have shown the safety in the preceding study.
Exclusion Criteria
-
Patients with Class IV Steinbrocker functional activity at evaluation within 4 weeks before treatment with the study drug
-
Patients who received any of the following treatments between the start of preceding study and the registration of this study.
- Plasma exchange therapy
- Surgical treatment (e.g., operation)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MRA(Tocilizumab) -
- Primary Outcome Measures
Name Time Method ACR 20% responder rate compared to the pre-treatment in the preceding study throughout study Frequency and severity of adverse events and adverse drug reactions week0,week4,week8,week12,and LOBS
- Secondary Outcome Measures
Name Time Method Time course of DAS28,compared to the pre-treatment in the preceding study week 0,week 4,week 8,week 12, LOBS Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study week 0,week 4,week 8,week 12, LOBS ACR N AUC compared to the pre-treatment in the preceding study week 0,week 4,week 8,week 12, LOBS Time course of the ACR core set variables compared to the pre-treatment in the preceding study week 0,week 4,week 8,week 12, LOBS