Rheumatoid Arthritis Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | February 2015 |
Est. primary completion date | February 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | UCLA David Geffen School of Medicine, Division of Rheumatology | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score | The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores. | baseline, 12 months | No |
Secondary | 12 Month Change in Power Doppler Ultrasound (PDUS) Scores | There were seven different joints in the hands and wrists evaluated to score the PDUS. | baseline, 12 months | No |
Secondary | 12 Month Change in Gray-scale Ultrasound (GSUS) | There were seven different joints in the hands and wrists evaluated to score the GSUS. | baseline, 12 months | No |
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