Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00235872
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

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

Key Dates

Start date
Aug 31, 2004
Status verified
Apr 2011
Primary completion
Jul 31, 2006

Study Design

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

Arms

  • Experimental: Adalimumab 40 mg every other week (eow)

Primary Outcome Measure

Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement Consisting of 20%, 50%, and 70% (ACR20/50/70 Responders, Respectively) [ Time Frame: Every 4 weeks up to Week 24 and every 12 weeks thereafter until Study completion or discontinuation (final value) ]

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