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

May 15, 2015 updated by: Dr. Veena Ranganath, University of California, Los Angeles

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA David Geffen School of Medicine, Division of Rheumatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score
Time Frame: baseline, 12 months
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
Time Frame: baseline, 12 months
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)
Time Frame: baseline, 12 months
There were seven different joints in the hands and wrists evaluated to score the GSUS.
baseline, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Veena K Ranganath, M.D., UCLA David Geffen School of Medicine, Division of Rheumatology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

February 18, 2011

First Submitted That Met QC Criteria

February 18, 2011

First Posted (Estimate)

February 21, 2011

Study Record Updates

Last Update Posted (Estimate)

June 10, 2015

Last Update Submitted That Met QC Criteria

May 15, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCLA Rheumatology RA 001
  • IND 111281 (Other Identifier: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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