Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

Sponsor
Chugai Pharmaceutical
Study ID
NCT00144508
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • MRA (Tocilizumab) — DRUG
    8mg /kg /4week for 52 weeks
  • current treatment — OTHER
    continue current treatment

Study Details

To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

Key Dates

Start date
Mar 31, 2003
Status verified
Jan 2009
Primary completion
May 31, 2004
Completion
Feb 28, 2006

Study Design

Enrollment
306 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Other: 2
    continue current treatment

Primary Outcome Measure

Change in the erosion score, as determined by the modified Sharp method. [ Time Frame: week 52 ]

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