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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01299961
• Other study ID #: UCLA Rheumatology RA 001
• Secondary ID: IND 111281
• Status: Completed
• Phase: Phase 3
• First received: February 18, 2011
• Last updated: May 15, 2015
• Start date: March 2011
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2015
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• abatacept
125 mg once a week up to 12 months.

Locations

Country	Name	City	State
United States	UCLA David Geffen School of Medicine, Division of Rheumatology	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No