An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

Sponsor
Centocor, Inc.
Study ID
NCT00207714
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Golimumab — DRUG
    Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous.
  • MTX — DRUG
    Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous
  • Placebo — DRUG
    Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub cutaneous
  • Infliximab — DRUG
    Type=exact, unit=mg/ml number= 10, form=powder for solution for infusion, route=sub cutaneous

Study Details

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Key Dates

Start date
Nov 30, 2003
Status verified
Oct 2012
Primary completion
Feb 28, 2005
Completion
Feb 28, 2006

Study Design

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

Arms

  • Experimental: Golimumab (CNTO 148) with Methotrexate (MTX)
  • Experimental: Infliximab with MTX
  • Placebo Comparator: Placebo with MTX

Primary Outcome Measure

Number of Participants Meeting the American College of Rheumatology 20 (ACR 20) Response at Week 16 [ Time Frame: Week 16 ]

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