Safety and Efficacy Study of Adalimumab in Adult Chinese Rheumatoid Arthritis Subjects Treated With Methotrexate

Sponsor
Abbott
Study ID
NCT00538902
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Placebo — BIOLOGICAL
    Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
  • Adalimumab 80 mg — BIOLOGICAL
    Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
  • Adalimumab 40 mg — BIOLOGICAL
    Adalimumab 40 mg administered subcutaneously every other week for 104 weeks

Study Details

A study to assess the safety and efficacy of adalimumab administered as a subcutaneous injection in adult Chinese subjects with rheumatoid arthritis and treated with methotrexate

Key Dates

Start date
Aug 31, 2007
Status verified
Apr 2011
Primary completion
Jul 31, 2008
Completion
Dec 31, 2009

Study Design

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

Arms

  • Placebo Comparator: Placebo
    Placebo administered subcutaneously every other week
  • Experimental: Adalimumab 80 mg
    Adalimumab 80 mg administered subcutaneously every other week
  • Experimental: Adalimumab 40 mg
    Adalimumab 40 mg administered subcutaneously every other week

Primary Outcome Measure

Number of Participants With American College of Rheumatology (ACR)20 at Week 12 of the Double-Blind Period [ Time Frame: Week 12 ]

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