Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
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
1 other identifier
interventional
115
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 rheumatoid-arthritis
Started Jun 2004
Longer than P75 for phase_3 rheumatoid-arthritis
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2009
CompletedDecember 23, 2009
December 1, 2009
1.2 years
September 2, 2005
December 21, 2009
Conditions
Outcome Measures
Primary Outcomes (3)
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
throughout study
Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions
throughout study
Pharmacokinetics of the serum MRA concentration
0W,4W,8W,12W,LOBS
Secondary Outcomes (1)
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
0W,4W,8W,12W,LOBS
Study Arms (1)
1
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Takahiro Kakehi
Chugai Pharmaceutical
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
June 1, 2004
Primary Completion
August 1, 2005
Study Completion
June 1, 2009
Last Updated
December 23, 2009
Record last verified: 2009-12