Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment abatacept
Phase phase 3
Sponsor University of California, Los Angeles
Start date March 2011
End date February 2014
Trial size 24 participants
Trial identifier NCT01299961, IND 111281, UCLA Rheumatology RA 001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Arm
(Experimental)
All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
abatacept
125 mg once a week up to 12 months.

Primary Outcomes

Measure
12 month change in 7-Joint Ultrasound (US) inflammatory score
time frame: baseline, 12 months

Secondary Outcomes

Measure
12 month change in Disease activity score (DAS); DAS28/ESR-4 item
time frame: baseline, 12 months
12 month change in Health assessment questionnaire-disability index (HAQ-DI)
time frame: baseline, 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis
Principal investigator Veena K Ranganath, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.