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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00144651 |
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Date of registration:
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02/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of MRA in Patients With Rheumatoid Arthritis (RA)
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Scientific title:
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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 |
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Date of first enrolment:
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August 2001 |
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Target sample size:
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135 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00144651 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Contacts
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Name:
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Takahiro Kakehi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Chugai Pharmaceutical |
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Key inclusion & exclusion criteria
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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.
1. Plasma exchange therapy
2. Surgical treatment (e.g., operation)
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: MRA(Tocilizumab)
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Primary Outcome(s)
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ACR 20% responder rate compared to the pre-treatment in the preceding study
[Time Frame: throughout study]
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Frequency and severity of adverse events and adverse drug reactions
[Time Frame: week0,week4,week8,week12,and LOBS]
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Secondary Outcome(s)
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Time course of DAS28,compared to the pre-treatment in the preceding study
[Time Frame: week 0,week 4,week 8,week 12, LOBS]
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ACR N AUC compared to the pre-treatment in the preceding study
[Time Frame: week 0,week 4,week 8,week 12, LOBS]
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Time course of the ACR 20%, 50%, and 70% responder rates compared to the pre-treatment in the preceding study
[Time Frame: week 0,week 4,week 8,week 12, LOBS]
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Time course of the ACR core set variables compared to the pre-treatment in the preceding study
[Time Frame: week 0,week 4,week 8,week 12, LOBS]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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