Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP

Sponsor
Chugai Pharmaceutical
Study ID
NCT00144547
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Apr 30, 2004
Status verified
Aug 2013
Primary completion
Aug 31, 2008
Completion
Jun 30, 2009

Study Design

Enrollment
241 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

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) [ Time Frame: 0W,4W,8W,12W,LOBS ]

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