Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

Sponsor
Chugai Pharmaceutical
Study ID
NCT00144521
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MRA(Tocilizumab) — DRUG
    8mg/kg/4week(i.v.)for 24 weeks
  • MRA placebo — DRUG
    0mg/kg/4week(i.v.) for 24 weeks
  • MTX — DRUG
    8mg/week(p.o.) for 24 weeks
  • MTX placebo — DRUG
    0mg/week(p.o.) for 24 weeks

Study Details

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.

Key Dates

Start date
Feb 29, 2004
Status verified
Jan 2009
Primary completion
Aug 31, 2004
Completion
Apr 30, 2006

Study Design

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

Arms

  • Experimental: 1
  • Active Comparator: 2

Primary Outcome Measure

Frequency of ACR 20% improvement [ Time Frame: week 24 ]

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