R-2487 in Patients With Rheumatoid Arthritis
R-2487-RA01
A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis
1 other identifier
interventional
73
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2023
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2023
CompletedFirst Posted
Study publicly available on registry
July 27, 2023
CompletedStudy Start
First participant enrolled
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
September 23, 2025
August 1, 2025
3.1 years
July 18, 2023
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
Baseline through week 4
Secondary Outcomes (2)
Change in Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)
Baseline through week 4
Change in Simplified Disease Activity Index (SDAI) Score over time
Baseline through week 4
Study Arms (3)
Four (4) week open label dose for Rheumatoid Arthritis patients
EXPERIMENTALR-2487 DP administered daily for 28 days
Six (6) week open label dose for Rheumatoid Arthritis patients
EXPERIMENTALR-2487 DP administered daily for 42 days
Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patients
EXPERIMENTALR-2487 DP administered daily for 28 days
Interventions
Probiotic
Eligibility Criteria
You may qualify if:
- 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. Sulfasalazine use is not permitted.
- Subjects may have received targeted synthetic DMARDs such as tofacitinib, baricitinib, and investigational therapies for RA if they have been washed out for 1 month prior to screening.
- Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent of ≤10 mg prednisone daily for at least 4 weeks. Subjects may not receive an IM, IV or IA administration of a corticosteroid within 4 weeks prior to screening visit or initiation of therapy.
- All male and female subjects who are biologically capable of having children must agree to use a medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of study drug. Any pregnancy that occurs in the female partner of a male subject in the trial must be reported if it occurs at any time during the study.
- Refrain from receiving any type of vaccinations during the study period (to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio).
You may not qualify if:
- Pregnancy (females, unless surgically sterile or at least two years post- menopausal must have a negative serum pregnancy test within 14 days prior to receiving the study drug and a negative urine pregnancy test on Study Day 0 before receiving the study drug).
- Nursing mothers.
- Subjects with autoimmune disease other than RA \[e.g., psoriasis, systemic lupus erythematosus (SLE), vasculitis, seronegative spondylarthritis, Inflammatory Bowel Disease, Sjogren's syndrome\] or currently active fibromyalgia.
- Subjects should not receive any of the following medications:
- Rituximab within 12 months prior to Day 1,
- Abatacept within 3 months prior to Day 1,
- Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or
- Mycophenolate mofetil within 2 months prior to Day 1, or
- Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1
- Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, baricitinib or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).
- Prior history of or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).
- Subjects at risk for tuberculosis (TB) defined as follows: Current clinical, radiographic or laboratory evidence of active TB. Chest x-rays (posterior, anterior and lateral) obtained within the 3 months prior to obtaining written informed consent will be permitted but the images must be available and reviewed by the investigator. TB testing (IFN-gamma release assay or PPD) performed in the past month prior to Screening will be accepted; however, a copy of the report must be placed in the subject binder.
- A history of active TB.
- Subjects with a positive TB screening test indicative of latent TB including subjects currently being treated for latent tuberculosis infection (LTBI) will not be eligible for the study.
- Subjects with recent acute infection defined as:
- +24 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
University of California, San Diego
San Diego, California, 92037, United States
St.Jude Clinical Research
Doral, Florida, 33172, United States
AP Medical Research
Miami, Florida, 33165, United States
Altoona Center for Research
Duncansville, Pennsylvania, 16635, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2023
First Posted
July 27, 2023
Study Start
October 19, 2023
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
September 23, 2025
Record last verified: 2025-08