Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Sponsor
Genentech, Inc.
Study ID
NCT00074438
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • methotrexate — DRUG
    Oral or parenteral repeating dose
  • rituximab — DRUG
    Intravenous repeating dose
  • corticosteroids — DRUG
    Intravenous repeating dose
  • placebo — DRUG
    Intravenous repeating dose

Study Details

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Key Dates

Start date
Jun 30, 2003
Status verified
May 2013
Primary completion
Sep 30, 2004
Completion
Jul 31, 2011

Study Design

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

Arms

  • Experimental: 1
  • Experimental: 2
  • Experimental: 3
  • Experimental: 4
  • Experimental: 5
  • Experimental: 6
  • Placebo Comparator: 7
  • Placebo Comparator: 8
  • Placebo Comparator: 9

Primary Outcome Measure

Proportion of patients with an ACR20 response [ Time Frame: 24 weeks ]

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