Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: abatacept

• Registration Number: NCT01299961
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-18
• Study First Submitted QC: 2011-02-18
• Study First Posted: 2011-02-21
• Study Start: 2011-03
• Primary Completion: 2013-02
• Results First Submitted: 2015-01-06
• Results First Submitted QC: 2015-01-20
• Results First Posted: 2015-01-30
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-15
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subcutaneous Abatacept	abatacept	All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.

Primary Outcome Measures

Name	Time	Method
12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score	baseline, 12 months	The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.

Secondary Outcome Measures

Name	Time	Method
12 Month Change in Power Doppler Ultrasound (PDUS) Scores	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)	baseline, 12 months	There were seven different joints in the hands and wrists evaluated to score the GSUS.

Trial Locations

Locations (1)

UCLA David Geffen School of Medicine, Division of Rheumatology; 🇺🇸 Los Angeles, California, United States