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.

Read more: http://www.clinicaltrials.gov/ct2/show/NCT01782469?cond=%22Arthritis%22&lup_s=08/23/2013&lup_d=30