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Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Butyrate
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Short Chain Fatty Acid, Butyrate, Microbiome, Methotrexate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone Health Orthopedic CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RA Patients who are Inadequate Responders to Current RA Treatment

Arm Description

Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.

Outcomes

Primary Outcome Measures

Change from Baseline in Microbiome Alpha Diversity
Measured by Shannon diversity index.

Secondary Outcome Measures

Change in Serum SCFA Concentration
Measured via participant blood draws.
Change in Fecal SCFA Concentration
Measured via participant stool samples.
Change in Peripheral Regulatory T Cell Concentration
Measured via participant blood draws.

Full Information

First Posted
January 30, 2023
Last Updated
February 8, 2023
Sponsor
NYU Langone Health
Collaborators
Arthritis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05718583
Brief Title
Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders
Acronym
EASi-RAIR
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Arthritis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Short Chain Fatty Acid, Butyrate, Microbiome, Methotrexate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RA Patients who are Inadequate Responders to Current RA Treatment
Arm Type
Experimental
Arm Description
Oral butyrate will be taken at 1000 mg three times daily with meals by RA patients who have active disease and are currently taking methotrexate (MTX) at prescriber's recommended dose. There will be no dose escalation of the study supplement. 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Butyrate
Other Intervention Name(s)
Butyrate; butyric acid
Intervention Description
Participants will self-administer the oral Short Chain Fatty Acid (SCFA) Butyrate supplement three times daily with meals for up to 2 months. The minimum duration necessary for an "evaluable" participant will be 2 weeks of SCFA supplementation.
Primary Outcome Measure Information:
Title
Change from Baseline in Microbiome Alpha Diversity
Description
Measured by Shannon diversity index.
Time Frame
Baseline, Month 1 Post-Treatment Initiation
Secondary Outcome Measure Information:
Title
Change in Serum SCFA Concentration
Description
Measured via participant blood draws.
Time Frame
Baseline, Month 1 Post-Treatment Initiation
Title
Change in Fecal SCFA Concentration
Description
Measured via participant stool samples.
Time Frame
Baseline, Month 1 Post-Treatment Initiation
Title
Change in Peripheral Regulatory T Cell Concentration
Description
Measured via participant blood draws.
Time Frame
Up to Month 1 Post-Treatment Initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of RA meeting 2010 ACR/EULAR for RA and/or treating MD diagnosis Inadequate response to MTX per treating MD at maximum tolerated dose. Able and willing to provide written informed consent prior to any study specific procedures Age 18 years and above at time of enrollment Subjects not excluded based on race or ethnicity Exclusion Criteria: Participants who are pregnant or are currently breastfeeding History of sensitivity to study compound or any of their excipients Previous intolerance to SCFA or related compounds Current antibiotic treatment (within 3 months of screening) at discretion of PI Current consumption of probiotics (within 3 months of screening) at discretion of PI Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) Renal failure (eGFR <30 or requiring dialysis) by history History of other autoimmune disease at discretion of PI Current immunodeficiency state (e.g., cancer, HIV, others)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca B. Blank, MD, PhD
Phone
212-598-6149
Email
Rebecca.blank@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Blank, MD, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health Orthopedic Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Rebecca.blank@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to Rebecca.blank@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders

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