Not Signed In -
Rheumatoid Arthritis |
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Clinical Trial: Long-Term Treatment Study of MRA for Rheumatoid Arthritis(RA) from Study MRA220JP or MRA221JP
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 paticipated in Study MRA220JP or MRA221JP
| 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 Paticipated in Study MRA220JP or MRA221JP
Further Study Details:
Primary Outcomes: Efficacy:; 20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.; Safety:; Incidence and severity of adverse events and adverse drug reactions; Pharmacokinetics:; The time course of the trough serum MRA concentration; at 0W, then every 4Wks
Secondary Outcomes: "Efficacy:; Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.; at 0W, then every 4Wks"
Expected Total Enrollment: 41
Secondary Outcomes: "Efficacy:; Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.; at 0W, then every 4Wks"
Expected Total Enrollment: 41
Study start: March 2005
Eligibility
Ages Eligible for Study: 20 Years - 75 Years, Genders Eligible for Study: Both
Criteria
Inclusion criteria
- RA patients who participated in the previous studies
- Patients who completed the last observation in the previous studies
- Patients who were confirmed to have no problems with safety in the previous studies.
Exclusion criteria
- Patients with Class IV Steinbrocker functional disorder at evaluation within 4 weeks before treatment with the investigational product
- Patients who were not enrolled by 3 months after the last observation day of the previous study
Location Information
Study chairs or principal investigators
Takahiro Kakehi, Study Director, Chugai Pharmaceutical Co., Ltd.
More Information
Study ID Numbers: MRA222JP
Last Updated: September 2, 2005
Record first received: September 2, 2005
ClinicalTrials.gov Identifier: NCT00144586
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: NCT00144586
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13
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