- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00144534
Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
December 21, 2009 updated by: Chugai Pharmaceutical
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 MRA213JP
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 MRA213JP.
Study Overview
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria
- Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
- In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preceding study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.
Exclusion criteria
- Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
- Evaluated as belonging to Steinbrocker's class IV within 4 weeks before administration of the study drug
- Have not been registered by 3 months after the full code-breaking of the preceding study
- Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
- Treated surgically (except for local surgery) within 4 weeks before administration of the study drug
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
8mg/kg/4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
Time Frame: throughout study
|
throughout study
|
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
Time Frame: throughout study
|
throughout study
|
Pharmacokinetics of the serum MRA concentration
Time Frame: 0W,4W,8W,12W,LOBS
|
0W,4W,8W,12W,LOBS
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: 0W,4W,8W,12W,LOBS
|
0W,4W,8W,12W,LOBS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
August 1, 2005
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
September 2, 2005
First Submitted That Met QC Criteria
September 2, 2005
First Posted (Estimate)
September 5, 2005
Study Record Updates
Last Update Posted (Estimate)
December 23, 2009
Last Update Submitted That Met QC Criteria
December 21, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRA215JP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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