Analyzing gut bacteria to predict treatment outcomes for rheumatoid arthritis patients using JAK-inhibitor
Microbiota Analysis to Predict Outcomes of Rheumatoid Arthritis Patients Treated With JAK-inhibitor
This study is testing if the types of bacteria in the gut can help predict how well rheumatoid arthritis patients will respond to a specific medication called upadacitinib.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | rituximab, tocilizumab, upadacitinib, tofacitinib, baricitinib, methotrexate |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT04530305 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the role of gut microbiota in predicting the response of rheumatoid arthritis patients to the JAK-inhibitor upadacitinib. By analyzing the composition of gut bacteria, the study seeks to identify factors that influence drug metabolism and immune response, which could lead to personalized treatment regimens. The research will focus on how gut microbiota affects drug efficacy and tolerability, potentially improving patient outcomes in rheumatoid arthritis management.
Who should consider this trial
Good fit: Ideal candidates include rheumatoid arthritis patients who have not responded adequately to methotrexate and are eligible for treatment with upadacitinib.
Not a fit: Patients with contraindications to upadacitinib or those who have previously been treated with biological DMARDs or JAK inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for rheumatoid arthritis patients.
How similar studies have performed: While the role of gut microbiota in predicting responses to anti-cancer drugs has been explored, its application in rheumatoid arthritis treatment with JAK-inhibitors is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with RA fulfilling American College of Rheumatology (ACR)/ European league against rheumatism (EULAR) 2010 criteria * Patients with inadequate response to MTX * Patients receiving MTX as adjuvant therapy or will receive UPA as monotherapy Exclusion Criteria: * Patients with contraindication to upadacitinib * Patients previously treated with biological DMARDs or JAK inhibitors * Patients treated with ≥ 10 mg/day of glucocorticoids * Use of IV glucocorticoids in the previous month * Previous use of biological DMARDs (TNF inhibitors, rituximab, abatacept, tocilizumab) or JAK inhibitors * Absence of informed consent * Pregnancy planned for the duration of the study, Women pregnant or breastfeeding women * Major protected by law or patient under guardianship
Where this trial is running
Montpellier
- CHU de Montpellier — Montpellier, France (Recruiting)
Study contacts
- Principal investigator: Claire DAIEN, Prof — Montpellier Hospital and University
- Study coordinator: Claire I DAIEN, Prof
- Email: c-daien@chu-montpellier.fr
- Phone: 467338710
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.