Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
Rheumatoid arthritis (RA) is a chronic inflammatory disease (a long-lasting disease causing pain and swelling) associated with significant health problems. It is a difficult disease to manage as the disease is often unpredictable. RA causes inflammation (swelling) of the joints that can cause joint damage, deformity, and progressive disability and impairment. It is estimated that 1% of the world's population suffers from this disease.
The purpose of this research study is to determine if a change in inflammation seen on the ultrasound is a good indicator of how subjects' rheumatoid arthritis is responding to treatment of subcutaneous abatacept at 3 weeks, 3 months, 6 months, and 12 months.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis|
- 12 month change in 7-Joint Ultrasound (US) inflammatory score [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.
- 12 month change in Disease activity score (DAS); DAS28/ESR-4 item [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]The DAS28/ESR-4 item score is a validated method of evaluating disease activity in rheumatoid arthritis.
- 12 month change in Health assessment questionnaire-disability index (HAQ-DI) [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]The HAQ-DI is a validate measure to evaluate function and quality of life in rheumatoid arthritis patients.
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Experimental: Subcutaneous Abatacept
All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
125 mg once a week up to 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299961
|United States, California|
|UCLA David Geffen School of Medicine, Division of Rheumatology|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Veena K Ranganath, M.D.||UCLA David Geffen School of Medicine, Division of Rheumatology|