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

Study Overview
=================
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.

Official Title
-----------------
Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: abatacept


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subcutaneous Abatacept<br>All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months. | Drug: abatacept<br>* 125 mg once a week up to 12 months.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid Arthritis, Subcutaneous Abatacept, Ultrasound