Post-marketing Observational Study in Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00234884
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    commercial adalimumab as prescribed by the rheumatologist in a normal clinical setting and in accordance with the Summary of Product Characteristics (SmPC)

Study Details

The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.

Key Dates

Start date
Sep 30, 2003
Status verified
Aug 2011
Primary completion
Jul 31, 2010
Completion
Jul 31, 2010

Study Design

Enrollment
3,435 participants (actual)

Arms

  • Arm: Adalimumab
    RA patients in treatment with commercial adalimumab

Primary Outcome Measure

Disease Activity Score in 28 Joints (DAS28) Based on Erythrocyte Sedimentation Rate (ESR) [ Time Frame: Baseline, Months 12, 24, 36, 48, and 60, and Last Observed Value ]

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