Phase 3
Completed N=25
Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01299961 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score — 11.4 units on a scale — p=<0.01
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score |
11.4 | <0.01 sig |
| SECONDARY 12 Month Change in Power Doppler Ultrasound (PDUS) Scores |
3.0 | <0.01 sig |
| SECONDARY 12 Month Change in Gray-scale Ultrasound (GSUS) |
1.2 | 0.19 |
Eligibility Criteria
Inclusion Criteria
- Over 18 years old
- Has a diagnosis of rheumatoid arthritis
- Stable DMARDs for at least 1 month (methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine)
- Disease activity score DAS28/ESR > 3.2 or all must be met: TJC (tender joint count)>=4, SJC (swollen joint count)>=4
- Must be able to understand information in the Informed Consent and comply with study requirements
- 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
- Current or prior use of biologic drugs (TNF inhibitors, IL-6 inhibitors, CD20 inhibitors, IL-1 inhibitors, etc.)
- Pregnancy or breast feeding
- Daily prednisone > 10mg (stable dose for at least 1 month)
- Intra-articular steroid injection of the wrist or joints within last 2 months
- History of a concomitant autoimmune disease such as lupus, psoriatic arthritis
- History of cancer
- Previous exposure to abatacept
Data sourced from ClinicalTrials.gov (NCT01299961). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.