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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01299961
First Posted: February 21, 2011
Last Update Posted: June 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Veena Ranganath, University of California, Los Angeles
  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: None (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 Dr. Veena Ranganath, University of California, Los Angeles:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Enrollment: 25
Study Start Date: March 2011
Study Completion Date: February 2015
Primary Completion Date: February 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: FDA )
First Submitted: February 18, 2011
First Posted: February 21, 2011
Results First Submitted: January 6, 2015
Results First Posted: January 30, 2015
Last Update Posted: June 10, 2015
Last Verified: May 2015

Keywords provided by Dr. Veena Ranganath, 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
Antirheumatic Agents