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NCT Number: NCT01299961

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, 90095, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Abatacept

Drug

125 mg once a week up to 12 months.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2015
First posted
Feb 21, 2011
Registry last updated
Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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