Clinical trial NCT01782469: Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population
Official title: A Prospective, Multi-center Study in Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Keywords: Synovitis
Rheumatoid Arthritis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Private clinics

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.

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

Primary outcomes:
measure: Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.
timeFrame: Baseline (Visit 1) to 13 weeks
Secondary outcomes:
measure: Mean Percent Reduction in Ultrasonography Assessment Score
timeFrame: Baseline (Visit 1) to 13 weeks
measure: Mean Number of Joints With Detected Erosions
timeFrame: Baseline (Visit 1) to 13 weeks
measure: Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)
timeFrame: Baseline (Visit 1) to 13 weeks
measure: Mean Change in Health Assessment Questionnaire (HAQ) Score
timeFrame: Baseline (Visit 1) to 13 weeks
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Iman Ibrahim
role: STUDY_DIRECTOR
References: