A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00647491
Phase
PHASE2/PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA

Key Dates

Start date
Feb 29, 2004
Status verified
Mar 2008
Primary completion
Jun 30, 2005
Completion
Aug 31, 2005

Study Design

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

Arms

  • Experimental: 20 mg
    20 mg adalimumab eow
  • Experimental: 40 mg
    40 mg adalimumab eow
  • Experimental: 80 mg
    80 mg adalimumab eow
  • Placebo Comparator: Placebo
    Placebo eow

Primary Outcome Measure

ACR20 [ Time Frame: Week 24 ]

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