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

NCT ID: NCT01782469

Last Updated: 2015-07-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-07-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Rheumatoid Arthritis (RA) participants

Male or female participants at least 18 years of age with diagnosis of RA

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:

• Male or Female patients ≥ 18 years of age with diagnosis of RA
• Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines
• Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study
• Patient has no history of inflammatory arthritis other than rheumatoid arthritis
• Patient has no history of lymphoma or leukemia or other malignancies
• Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion Criteria

• Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria
• Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression
• Susceptibility to infections including TB, as judged by the investigator
• Patient is carrier of Hepatitis B virus
• Patient is a pregnant or lactating female at the time of screening

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Iman Ibrahim

Role: STUDY_DIRECTOR

AbbVie

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

P13-708

Identifier Type: -

Identifier Source: org_study_id