Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
| Status: | Completed |
|---|---|
| Conditions: | Arthritis, Rheumatoid Arthritis |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/27/2013 |
| Start Date: | March 2011 |
| End Date: | March 2014 |
| Contact: | Veena K Ranganath, M.D. |
| Email: | vranganath@mednet.ucla.edu |
| Phone: | 310-825-6301 |
Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in 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.
Inclusion Criteria:
1. Over 18 years old
2. Has a diagnosis of rheumatoid arthritis
3. Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or
sulfasalazine)
4. Disease activity score DAS28/ESR > 3.2 or all must be met: TJC (tender joint
count)>=4, SJC (swollen joint count)>=4
5. Must be able to understand information in the Informed Consent and comply with study
requirements
6. Total ultrasound synovitis (inflammation of joint-lining membrane) power Doppler
score >=1 for at least 2 joints and total synovitis score >=1 for at least 1 joint
Exclusion Criteria:
1. Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20
inhibitors, IL-1 inhibitors, etc.)
2. Pregnancy or breast feeding
3. Daily prednisone > 10mg (stable dose for at least 1 month)
4. Intra-articular steroid injection of the wrist or joints within last 2 months
5. History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
6. History of cancer
7. Previous exposure to abatacept
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