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

NCT01782469 | Terminated Results

• 1 other identifier: P13-708
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis

Keywords

Synovitis; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab.

  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.

  Baseline (Visit 1) to 13 weeks

Secondary Outcomes (4)

• Mean Percent Reduction in Ultrasonography Assessment Score

  Baseline (Visit 1) to 13 weeks

• Mean Number of Joints With Detected Erosions

  Baseline (Visit 1) to 13 weeks

• Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC)

  Baseline (Visit 1) to 13 weeks

• Mean Change in Health Assessment Questionnaire (HAQ) Score

  Baseline (Visit 1) to 13 weeks

Study Arms (1)

Rheumatoid Arthritis (RA) participants

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Private clinics

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Synovitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Iman Ibrahim

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2013
• First Posted: February 4, 2013
• Study Start: October 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 30, 2015
• Results First Posted: July 30, 2015

Record last verified: 2015-07