NCT01782469

Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

A Prospective, Multi-center Study in Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 16 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.

Detailed description

This study was a prospective, observational, single arm, multicenter study. Participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. A total of 5 visits were planned: Baseline (Visit 1), Visits 2, 3, 4 and 5 (Week 13). The time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. Additional study objectives were to investigate the rate of RA progression via changes in the B-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. The study was terminated due to low enrollment.

Conditions

• Rheumatoid Arthritis

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-02-04
• Last updated: 2015-07-30
• Results posted: 2015-07-30