R-2487-RA01: R-2487 in Patients With Rheumatoid Arthritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Open Label Probiotic |
Drug: R-2487
Probiotic
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration [Baseline through week 4]
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
Secondary Outcome Measures
- Change in Disease Activity Score-28 joint C-Reactive Protein DAS28 (CRP) [Baseline through week 4]
Change from Baseline in DAS28 (CRP) Score at Week 6
- Change in Simplified Disease Activity Index (SDAI) Score over time [Baseline through week 4]
Baseline SDAI Score over time
Eligibility Criteria
Criteria
Inclusion Criteria:
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Ages 18-75 years (Inclusive).
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Able to provide written informed consent.
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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.
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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.
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Subjects may be able to be on hydroxychloroquine, methotrexate, and leflunomide. Sulfasalazine use is not permitted.
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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.
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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.
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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.
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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).
Exclusion Criteria:
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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).
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Nursing mothers.
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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.
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Subjects should not receive any of the following medications:
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Rituximab within 12 months prior to Day 1,
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Abatacept within 3 months prior to Day 1,
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Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or
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Mycophenolate mofetil within 2 months prior to Day 1, or
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Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1
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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).
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Prior history of or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).
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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.
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A history of active TB.
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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.
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Subjects with recent acute infection defined as:
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Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics,
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Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy,
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Subjects with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.),
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Subjects with any history of infection of a joint prosthesis or artificial joint,
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Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis),
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Subjects with history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster will be excluded,
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Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening,
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Subjects with history of primary immunodeficiency.
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Subjects with history of Human Immunodeficiency Virus (HIV) infection or who tested positive for HIV.
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Evidence of infection with hepatitis B virus (HBV), hepatitis C virus (C), human immunodeficiency virus (HIV)-1 or HIV-2, or active infection with hepatitis A, as determined by results of testing at screening.
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Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non- metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.
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Current clinical findings of a history of a demyelinating disorder.
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New York Heart Association (NYHA) Class III or IV heart failure.
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Subjects who have undergone a major surgical procedure within the 60 days prior to enrollment.
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Subjects for whom 5 or more joints cannot be assessed for tenderness or swelling (i.e. due to surgery, fusion, amputation, etc.).
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Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:
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Hemoglobin level < 9.0 g/dL,
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Absolute white blood cell (WBC) count of <3.0×109/L (<3000/mm3), or absolute neutrophil count of <1.2×109/L (<1200/mm3), or absolute lymphocyte count of <0.8×109/L (<800/mm3),
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Thrombocytopenia, defined by platelet count <100×109/L (<100,000/mm3),
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Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2, based on the age-appropriate calculation,
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Proteinuria ≥3+,
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Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN)
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Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (> F3).
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Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dartmouth Hitchcock Medical Center (DHMC) | Lebanon | New Hampshire | United States | 03766 |
Sponsors and Collaborators
- Rise Therapeutics LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RISE-2487-RA01