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

University of California, Los Angeles25 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

abatacept

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: baseline, 12 months

Secondary Outcomes

12 Month Change in Power Doppler Ultrasound (PDUS) Scores

There were seven different joints in the hands and wrists evaluated to score the PDUS.

Time frame: baseline, 12 months

12 Month Change in Gray-scale Ultrasound (GSUS)

There were seven different joints in the hands and wrists evaluated to score the GSUS.

Time frame: baseline, 12 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes