A pilot proof of concept study of the Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)

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A pilot proof of concept study of the Effects of Administration of SCFA in Rheumatoid Arthritis Inadequate Responders (EASi-RAIR)

Brief description of study

This study is a pilot, proof of concept study to determine the effects of administering an oral SCFA supplement to RA patients with inadequate response to methotrexate. We will include up to 65 participants to obtain a sample size of at least 25 participants taking the oral supplement. We 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, with an optional 2 month time-point and optional visit up to 12 months following starting treatments with the next line of therapy. Fecal microbiome will be analyzed. Adaptive immune responses will be analyzed from participant blood samples.

Clinical Study Identifier: s22-01526

ClinicalTrials.gov Identifier: NCT05718583

Principal Investigator: Jose U Scher.

Other Investigator: Rebecca Barbara Blank.

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