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NCT05718583 | RECRUITING | Rheumatoid Arthritis

Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
Sponsor:

NYU Langone Health

Brief Summary:

This study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (SCFA) supplement to Rheumatoid Arthritis (RA) patients with inadequate response to methotrexate (MTX). The study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. The researchers hypothesize that oral SCFA will change the participants' gut microbiome and regulatory immune responses. Clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2 month time-point. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.

Condition or disease

Rheumatoid Arthritis

Intervention/treatment

Butyrate

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 35 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Pilot Proof of Concept Study of the Effects of Administration of a Short Chain Fatty Acid (SCFA) Supplement in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)
Actual Study Start Date : 2023-02-01
Estimated Primary Completion Date : 2025-02-01
Estimated Study Completion Date : 2025-02-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis
  • 2. Inadequate response to MTX per treating MD at maximum tolerated dose.
  • 3. Able and willing to provide written informed consent prior to any study specific procedures
  • 4. Age 18 years and above at time of enrollment
  • 5. Subjects not excluded based on race or ethnicity
Exclusion Criteria
  • 1. Participants who are pregnant or are currently breastfeeding
  • 2. History of sensitivity to study compound or any of their excipients
  • 3. Previous intolerance to SCFA or related compounds
  • 4. Current antibiotic treatment (within 3 months of screening) at discretion of PI
  • 5. Current consumption of probiotics (within 3 months of screening) at discretion of PI
  • 6. Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
  • 7. Renal failure (eGFR \<30 or requiring dialysis) by history
  • 8. History of other autoimmune disease at discretion of PI
  • 9. Current immunodeficiency state (e.g., cancer, HIV, others)
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

Location Details

NCT05718583

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

NYU Langone Health Orthopedic Center

New York, New York, United States, 10016