A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis
Rise Therapeutics LLC
Summary
The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Rheumatoid Arthritis. Patients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Rheumatoid Arthritis. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ages 18-75 years (Inclusive). * Able to provide written informed consent. * Men or women (not nursing or pregnant) who have active RA, defined as symptoms of RA prior to screening and have satisfied the ACR/EULAR 2010 criteria for the classification of RA prior to signing the informed consent. * Subjects must have a CDAI \> 10.0 at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal) at screening and at Day 1, based on the DAS28 joint count. * Subjects may be able to be on hydroxychloroquine, methotrexate, and leflunomide.…
Interventions
- DrugR-2487 DP
Probiotic
Locations (5)
- University of California, San DiegoSan Diego, California
- St.Jude Clinical ResearchDoral, Florida
- AP Medical ResearchMiami, Florida
- Altoona Center for ResearchDuncansville, Pennsylvania
- Prolato Clinical Research CenterHouston, Texas