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 MRA012JP
Sponsor study identifier
interventional
241
0 countries
N/A
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
June 2009
Actual (reported)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 MRA012JP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2009
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 2, 2005
Actual (reported)September 5, 2005
Actual (reported)August 2008
Actual (reported)June 2009
Actual (reported)Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
0W,4W,8W,12W,LOBS
Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria
0W,4W,8W,12W,LOBS
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
Frequency, severity, and seriousness of adverse events and adverse drug reactions
Throughout study
Takahiro Kakehi
Chugai Pharmaceutical
241 participants (actual enrollment reported by the registry).
First Submitted
September 2, 2005
First Posted
September 5, 2005
Study Start
April 2004
Date type not reportedThis date has not been verified as actual or estimated.
Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)
Contact the study team to confirm eligibility.
Primary Completion
August 2008
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
August 9, 2013
Record last verified: 2013-08
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Source: ClinicalTrials.gov.
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