RECRUITING

Analysis of T and B Cell Repertoire Changes in Response to Orencia® (Abatacept) in Rheumatoid Arthritis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The condition that will be studied is Rheumatoid Arthritis (RA), and in particular, RA patients with moderate to highly active disease who were prescribed Abatacept (Orencia®) (ABA) by their physician during their setting of care at Hospital for Special Surgery (HSS). This investigator-initiated, prospective, comparative, 3-arm observational study will examine changes in lymphocytes in RA patients starting abatacept compared to RA patients starting TNF inhibitors and to healthy controls. This will help investigators to learn more about the processes that cause joints to swell and hurt. This may also offer clues that might predict which patients will have a good or poor response to these treatments.

Official Title

Analysis of T and B Cell Repertoire Changes and CTLA4 Genetics and Gene Expression to Understand the Mechanisms of Treatment Response to Orencia ® (Abatacept) in Rheumatoid Arthritis

Quick Facts

Study Start:2022-11-01
Study Completion:2025-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05782335

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Have severe complications of RA that might require imminent escalation of therapy, e.g. pericarditis, active vasculitis of a major organ system.
  2. 2. Have an autoimmune disease or systemic inflammatory rheumatic disease (e.g., lupus erythematosus) that could confound T and B cell subset results
  3. 3. Have a concurrent serious medical disease (e.g., terminal malignancy)
  4. 4. Have a BMI indicating poor health (\<18 or \> 40)
  5. 5. Have received the following Prohibited Treatments and/or Therapies
  6. 1. treatment with rituximab
  7. 2. exposed to ABA or CTLA-4Ig
  8. 3. exposed to any investigational drug within 28 days.
  9. 4. received any live vaccines within 2 weeks prior to study start. Subjects cannot receive a live vaccine at any time during the study.
  10. 6. WOCBP with a positive pregnancy test on enrollment or prior to study start, OR who are unwilling or unable to use an acceptable method to avoid pregnancy despite continuing MTX.
  11. 7. part of a vulnerable population

Contacts and Locations

Study Contact

Margaret Butler, BS
CONTACT
917-260-4906
ButlerM@hss.edu
Caroline Reidy, MPH
CONTACT
646-704-3426
ReidyC@hss.edu

Principal Investigator

Louis Bridges, MD PhD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York
Vivian P Bykerk, MD
PRINCIPAL_INVESTIGATOR
Hospital for Special Surgery, New York

Study Locations (Sites)

Hospital for Special Surgery
New York, New York, 10021
United States

Collaborators and Investigators

Sponsor: Hospital for Special Surgery, New York

  • Louis Bridges, MD PhD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York
  • Vivian P Bykerk, MD, PRINCIPAL_INVESTIGATOR, Hospital for Special Surgery, New York

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 Registration Dates

Study Start Date2022-11-01
Study Completion Date2025-04-30

Study Record Updates

Study Start Date2022-11-01
Study Completion Date2025-04-30

Terms related to this study

Keywords Provided by Researchers

  • abatacept
  • b cell repertoire
  • t cell repertoire

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis