Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00235833
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    40 mg every other week (eow), subcutaneous (sc)

Study Details

The purpose of the study is to assess the long-term safety, tolerability, and efficacy of repeated administration of adalimumab in adult Japanese subjects with rheumatoid arthritis.

Key Dates

Start date
Jun 30, 2003
Status verified
Apr 2011
Primary completion
Oct 31, 2004

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adalimumab 40 mg eow

Primary Outcome Measure

Number of Responders With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders) [ Time Frame: Every 6 weeks up to Week 24 and every 12 weeks thereafter up to study completion or discontinuation (final value) ]

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