Actively Recruiting
R-2487 in Patients With Rheumatoid Arthritis
Led by Rise Therapeutics LLC · Updated on 2025-09-23
73
Participants Needed
5
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
R-2487 in Patients With Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18-75 years (Inclusive).
- Able to provide written informed consent.
- Men or women (not nursing or pregnant) with active Rheumatoid Arthritis meeting ACR/EULAR 2010 criteria.
- CDAI greater than 10.0 at screening with at least 3 tender and 3 swollen joints (excluding distal interphalangeal) at screening and Day 1.
- May be on hydroxychloroquine, methotrexate, and leflunomide; sulfasalazine is not allowed.
- May have used targeted synthetic DMARDs or investigational RA therapies if washed out for 1 month prior to screening.
- Stable oral corticosteroid dose equivalent to ≤10 mg prednisone daily for at least 4 weeks; no IM, IV, or IA corticosteroids within 4 weeks prior to screening.
- Biologically capable males and females of childbearing potential must use acceptable birth control during the study; females must have a negative pregnancy test before study drug administration.
- Must refrain from receiving any vaccinations during the study period.
You will not qualify if you...
- Pregnancy or nursing mothers.
- Autoimmune diseases other than RA (e.g., psoriasis, systemic lupus erythematosus, vasculitis, seronegative spondylarthritis, inflammatory bowel disease, Sjogren's syndrome) or active fibromyalgia.
- Use of specific immunomodulatory medications within restricted timeframes before Day 1 (e.g., rituximab, abatacept, certain biologics).
- Prior immunotherapy not completed at least 5 half-lives or 30 days prior to Day 0.
- History or current inflammatory joint disease other than RA.
- Risk for tuberculosis or positive TB screening tests.
- Recent acute infections requiring hospitalization or antibiotic/antiviral treatment.
- History of chronic or recurrent bacterial infections or systemic fungal infections.
- History of recurrent or disseminated herpes zoster or herpes simplex infections.
- Primary immunodeficiency or HIV infection.
- Evidence of infection with hepatitis B, C, or active hepatitis A.
- Current or recent malignancy within 5 years except certain skin or cervical cancers.
- History of demyelinating disorders.
- NYHA Class III or IV heart failure.
- Major surgery within 60 days prior to enrollment.
- Inability to assess 5 or more joints for tenderness or swelling.
- Severe, progressive, or uncontrolled diseases affecting multiple organ systems with specified laboratory abnormalities.
- Vaccination within the last 30 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University of California, San Diego
San Diego, California, United States, 92037
Actively Recruiting
2
St.Jude Clinical Research
Doral, Florida, United States, 33172
Actively Recruiting
3
AP Medical Research
Miami, Florida, United States, 33165
Actively Recruiting
4
Altoona Center for Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
5
Prolato Clinical Research Center
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
J
Janet Stephens, PhD
CONTACT
C
Christian Freguia, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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