Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
|ClinicalTrials.gov Identifier: NCT01299961|
Recruitment Status : Completed
First Posted : February 21, 2011
Results First Posted : January 30, 2015
Last Update Posted : June 10, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: abatacept||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2015|
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.
- 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score [ Time Frame: baseline, 12 months ]The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.
- 12 Month Change in Power Doppler Ultrasound (PDUS) Scores [ Time Frame: baseline, 12 months ]There were seven different joints in the hands and wrists evaluated to score the PDUS.
- 12 Month Change in Gray-scale Ultrasound (GSUS) [ Time Frame: baseline, 12 months ]There were seven different joints in the hands and wrists evaluated to score the GSUS.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|