Not Signed In -
Rheumatoid Arthritis |
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Clinical Trial: Long-Term Treatment Study of MRA for Rheumatoid Arthritis(RA) from Study MRA012JP
This study is no longer recruiting patients.
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Purpose
An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who were participated in Study MRA012JP
| Condition | Intervention | Phase |
|---|---|---|
| Rheumatoid Arthritis | Drug: MRA(Tocilizumab) | Phase III |
MedlinePlus related topics: Rheumatoid Arthritis
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: An Open-Label, Extension, Phase III Study to Evaluate the Long-Term Safety and Efficacy of MRA in Patients with RA Who Were Participated in Study MRA012JP
Further Study Details:
Primary Outcomes: Efficacy:; The frequency of amelioration of at least 20% in terms of the ACR criteria; Safety:; Frequency, severity, and seriousness of adverse events and adverse drug reactions; at 0W,4W,8W,12W,LOBS
Secondary Outcomes: Efficacy:; Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set; at 0W,4W,8W,12W,LOBS
Expected Total Enrollment: 52
Secondary Outcomes: Efficacy:; Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set; at 0W,4W,8W,12W,LOBS
Expected Total Enrollment: 52
Study start: April 2004
Eligibility
Ages Eligible for Study: 20 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion criteria
- Patients must suffer from RA, and must have participated in the preceding study.
- Patients must have been confirmed to be appropriate on week 52 of the preceding study by X radiography.
Exclusion criteria
- Patients evaluated as belonging to Steinbrocker’s class IV within 4 weeks before administration of the study drug
- Patients who have not been registered by 3 months after week 52 of the preceding study
Location Information
Study chairs or principal investigators
Takahiro Kakehi, Study Director, Chugai Pharmaceutical Co., Ltd.
More Information
Study ID Numbers: MRA214JP
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144547
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144547
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
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