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

• ClinicalTrials.gov Identifier: NCT01782469
• Recruitment Status: Terminated
• First Posted: February 4, 2013
• Results First Posted: July 30, 2015
• Last Update Posted: July 30, 2015
• Sponsor: AbbVie (prior sponsor, Abbott)
• Information provided by (Responsible Party): AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information

• First Submitted Date: January 31, 2013
• First Posted Date: February 4, 2013
• Results First Submitted Date: July 2, 2015
• Results First Posted Date: July 30, 2015
• Last Update Posted Date: July 30, 2015
• Study Start Date: October 2012
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 2, 2015)

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

Original Primary Outcome Measures (submitted: January 31, 2013)

The average change in synovitis measured by B-modal Ultrasonography assessment score after 13 weeks of treatment with Adalimumab [ Time Frame: From Week 0 to Week 13 ]

Presence of synovitis and joint fluid is scored on a scale from 0 to 3 (0=none,1=minor,2=moderate,3=major presence). The sum of scores of all 12 joints will be taken as the ultrasonography assessment score (giving a score range of 0 - 36). The 12 joints to be assessed are elbow, wrist, second metacarpophalangeal (MCP) joint, third MCP, knee and ankle, all on both sides.

Current Secondary Outcome Measures (submitted: July 2, 2015)

• Mean Percent Reduction in Ultrasonography Assessment Score [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.

Original Secondary Outcome Measures (submitted: January 31, 2013)

• The mean change in ultrasonography assessment score from Screening through Week12 [ Time Frame: From Week 0 to Week 12 ]
  (on a scale from 0 - 3 for each joint) and the sum of all 12 joint scores (on a scale from 0 - 36).
• The mean number of joints with detected erosions between Week 0 and Week 12 [ Time Frame: From Week 0 to Week 12 ]
  Number of joints with detected synovitis and/or erosion ultrasonography
• Percentage of patients who achieved an American College of Rheumatology 20 score(ACR20) response at Week 12 [ Time Frame: 12 weeks ]
  Tender joint count (TJC), swollen joint count (SJC), patient assessment of pain, patient assessment of disease activity, physician assessment of disease activity
• The mean change in Health Assessment Questionnaire (HAQ) score [ Time Frame: From Week 0 to Week 12 ]
  on a scale from 0 to 3, where 0 means no difficulty and 3 means unable to perform activity

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Private clinics
• Condition: Rheumatoid Arthritis
• Intervention: Not Provided

Study Groups/Cohorts

Rheumatoid Arthritis (RA) participants

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: July 2, 2015): 16
• Original Estimated Enrollment (submitted: January 31, 2013): 60
• Actual Study Completion Date: July 2014
• Actual Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Egypt

Administrative Information

• NCT Number: NCT01782469
• Other Study ID Numbers: P13-708
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
• Original Responsible Party: Abbott (Egypt)
• Current Study Sponsor: AbbVie (prior sponsor, Abbott)
• Original Study Sponsor: Abbott (Egypt)
• Collaborators: Not Provided

Investigators

• Study Director: Iman Ibrahim; AbbVie

• PRS Account: AbbVie
• Verification Date: July 2015