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

Terminated

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01782469
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-31
• Study First Submitted QC: 2013-01-31
• Study First Posted: 2013-02-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2015-07
• Results First Submitted: 2015-07-02
• Results First Submitted QC: 2015-07-02
• Last Update Submitted: 2015-07-02
• Results First Posted: 2015-07-30
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.	Baseline (Visit 1) to 13 weeks	Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Reduction in Ultrasonography Assessment Score	Baseline (Visit 1) to 13 weeks	Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36.
Mean Number of Joints With Detected Erosions	Baseline (Visit 1) to 13 weeks	A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented.
Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)	Baseline (Visit 1) to 13 weeks	The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC).
Mean Change in Health Assessment Questionnaire (HAQ) Score	Baseline (Visit 1) to 13 weeks	The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks.