Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00603993
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection

Study Details

The purpose of this study is to evaluate the long-term safety of subcutaneous (SC) self-injections (by the subject or subject's family member) of adalimumab in adult Japanese subjects with Rheumatoid Arthritis in an open-label study.

Key Dates

Start date
Mar 31, 2006
Status verified
Jun 2011
Primary completion
Nov 30, 2006

Study Design

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

Arms

  • Experimental: Adalimumab
    Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 \[NCT 00235872\]) subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan

Primary Outcome Measure

Number of Subjects With American College of Rheumatology (ACR) Criteria Improvement of at Least 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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