Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography in an Egyptian Population
This Post-Marketing Observational Study (PMOS) aims to assess the effectiveness of Adalimumab on reducing synovitis This is assessed by ultrasonography in Rheumatoid Arthritis (RA) patients in Egypt. The study will collect B-mode ultrasonography data from RA patients who are on Adalimumab and have not been treated with any other anti-TNF therapy in the past.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Prospective, Multi-center, Post-marketing Observational Study on Rheumatoid Arthritis Patients on Adalimumab to Evaluate Its Effect on Synovitis Using Ultrasonography on Egyptian Population|
- The average change in synovitis measured by B-modal Ultrasonography assessment score after 13 weeks of treatment with Adalimumab. [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]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 MCP, third MCP, knee and ankle, all on both sides.
- The mean change in ultrasonography assessment score from Screening through Week12 [ Time Frame: From Week 0 to Week 12 ] [ Designated as safety issue: No ](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 ] [ Designated as safety issue: No ]Number of joints with detected synovitis and/or erosion ultrasonography
- Percentage of patients who achieved an ACR20 response at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]on a scale from 0 to 3, where 0 means no difficulty and 3 means unable to perform activity
|Study Start Date:||October 2012|
|Study Completion Date:||July 2014|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Rheumatoid Arthritis (RA) patients
Male or female patients at least 18 years of age with diagnosis of RA
The purpose of this study is to evaluate the changes in synovitis of Egyptian rheumatoid arthritis patients who are on Adalimumab.
A sample size of 60 patients is targeted. The number of sites targeted is around 5 sites with approximately 12 patients per site.
Patients are observed over a period of maximum 13 weeks of treatment with Adalimumab during which a maximum of 5 visits are performed.
Analysis will be performed on the intention-to-treat population. Missing data will be counted as missed and patients whose ultrasonography or appropriate American College of Rheumatology (ACR) assessments are missing will be ignored from the analysis of the assessment for which data was missing.
All variables recorded during the study will be summarized. Absolute and relative frequencies will be provided for categorical endpoints. Mean, standard deviation, median, quartiles, minimum and maximum will be provided for continuous endpoints. Two-sided 95% confidence intervals will be provided as appropriate. All adverse events reported during the study will be tabulated using frequency tables with intensity and actions taken.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01782469
|Site Reference ID/Investigator# 95896|
|Cairo, Egypt, 11311|
|Site Reference ID/Investigator# 95897|
|Site Reference ID/Investigator# 95898|
|Cairo, Egypt, 11341|
|Site Reference ID/Investigator# 95899|
|Site Reference ID/Investigator# 75093|
|Giza, Egypt, 12411|
|Study Director:||Rasha Eldessouky, MD||Abbott (Egypt)|