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

NCT01299961 | Completed Phase 3 Results

• 2 other identifiers: UCLA Rheumatology RA 001IND 111281
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Subcutaneous Abatacept; Ultrasound

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 12 Month Change in Power Doppler Ultrasound (PDUS) Scores

  baseline, 12 months

• 12 Month Change in Gray-scale Ultrasound (GSUS)

  baseline, 12 months

Study Arms (1)

Subcutaneous Abatacept

EXPERIMENTAL

All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.

Drug: abatacept

Interventions

abatacept DRUG

125 mg once a week up to 12 months.

Subcutaneous Abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA David Geffen School of Medicine, Division of Rheumatology

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• Charles-Schoeman C, Wang J, Shahbazian A, Wilhalme H, Brook J, Kaeley GS, Oganesian B, Ben-Artzi A, Elashoff DA, Ranganath VK. Power doppler ultrasound signal predicts abnormal HDL function in patients with rheumatoid arthritis. Rheumatol Int. 2023 Jun;43(6):1041-1053. doi: 10.1007/s00296-023-05285-7. Epub 2023 Feb 24.

  PMID: 36828925 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Limitations and Caveats

This is a very small open-label study of 25 patients on a FDA approved drug, where efficacy (by standard validated measures) and safety were not the primary end points.

Results Point of Contact

• Title: Veena K. Ranganath, MD, MS Assistant Clinical Professor
• Organization: UCLA

vranganath@mednet.ucla.edu

310-825-3061

Study Officials

• Veena K Ranganath, M.D.

  UCLA David Geffen School of Medicine, Division of Rheumatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Assistant Clinical Professor

Study Record Dates

• First Submitted: February 18, 2011
• First Posted: February 21, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2015
• Last Updated: June 10, 2015
• Results First Posted: January 30, 2015

Record last verified: 2015-05

Locations

US (1)