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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01299961
First received: February 18, 2011
Last updated: July 3, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: abatacept
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Musculoskeletal Ultrasound as a Marker of Therapeutic Response to Abatacept in Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • 12 month change in 7-Joint Ultrasound (US) inflammatory score [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.


Secondary Outcome Measures:
  • 12 month change in Disease activity score (DAS); DAS28/ESR-4 item [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    The DAS28/ESR-4 item score is a validated method of evaluating disease activity in rheumatoid arthritis.

  • 12 month change in Health assessment questionnaire-disability index (HAQ-DI) [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
    The HAQ-DI is a validate measure to evaluate function and quality of life in rheumatoid arthritis patients.


Estimated Enrollment: 24
Study Start Date: March 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299961

Locations
United States, California
UCLA David Geffen School of Medicine, Division of Rheumatology
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Veena K Ranganath, M.D. UCLA David Geffen School of Medicine, Division of Rheumatology
  More Information

No publications provided

Responsible Party: Dr. Veena Ranganath, M.D., Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01299961     History of Changes
Other Study ID Numbers: UCLA Rheumatology RA 001, IND 111281
Study First Received: February 18, 2011
Last Updated: July 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Rheumatoid Arthritis
Subcutaneous Abatacept
Ultrasound

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014