R-2487 in Patients With Rheumatoid Arthritis
A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Rheumatoid Arthritis
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety of R-2487, a probiotic taken by mouth, and how well people can tolerate it. It is for adults ages 18–75 with active rheumatoid arthritis (RA), a disease that causes swollen, painful joints. Doctors will check joints and test blood and stool for inflammation and stool for R-2487.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–75 years old and able to give written consent to join.
- Have active RA that meets the study’s diagnosis rules.
- Have an RA activity score above 10 at screening, with at least 3 tender and 3 swollen joints at screening and Day 1.
- Hydroxychloroquine, methotrexate, and leflunomide may be allowed. Sulfasalazine is not allowed.
- Certain RA drugs, including tofacitinib, baricitinib, and study treatments, must be stopped at least 1 month before screening. Longer waiting times may apply.
- If taking steroid pills, use a steady dose equal to no more than 10 mg of prednisone daily for at least 4 weeks. No steroid shots into muscles, veins, or joints within 4 weeks before screening or starting treatment.
- If able to have children, agree to use accepted birth control during the study. Women must have negative pregnancy tests. Men must report any pregnancy in their partner during the study.
- Agree not to get any vaccines during the study.
Who can't join
- Are pregnant or breastfeeding.
- Have another disease where the immune system attacks the body, active fibromyalgia, or a past or current inflammatory joint disease other than RA.
- Have used certain immune-system drugs or blood products too recently. Required waiting times range from 28 days to 12 months, depending on the treatment.
- Have active or past tuberculosis (TB), or a positive test for TB that is not causing symptoms, even if being treated.
- Have certain recent, long-lasting, or repeated infections; an infected artificial joint in the past; certain fungal or herpes infections; an immune deficiency; HIV; hepatitis B or C; or active hepatitis A.
- Have current cancer, possible cancer not yet ruled out, or cancer within the past 5 years, with some exceptions for cured skin or early cervical cancers.
- Have certain serious or uncontrolled illnesses, including severe heart failure, nerve-covering damage, kidney or liver disease, or blood test results outside the study’s limits.
- Had major surgery within 60 days before enrollment, have 5 or more joints that cannot be checked, or received any vaccine within the past 30 days.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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. 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). Exclusion Criteria: * 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: * Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics, * Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy, * Subjects with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.), * Subjects with any history of infection of a joint prosthesis or artificial joint, * Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis), * 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, * Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening, * Subjects with history of primary immunodeficiency. * Subjects with history of Human Immunodeficiency Virus (HIV) infection or who tested positive for HIV. * 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. * 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. * Current clinical findings of a history of a demyelinating disorder. * New York Heart Association (NYHA) Class III or IV heart failure. * Subjects who have undergone a major surgical procedure within the 60 days prior to enrollment. * Subjects for whom 5 or more joints cannot be assessed for tenderness or swelling (i.e. due to surgery, fusion, amputation, etc.). * Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following: * Hemoglobin level \< 9.0 g/dL, * 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), * Thrombocytopenia, defined by platelet count \<100×109/L (\<100,000/mm3), * Chronic kidney disease defined as Estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2, based on the age-appropriate calculation, * Proteinuria ≥3+, * Total bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN) * Previously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (\> F3). * 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.
Study sites (6)
CA
- University of California, San Diego · San Diego, CA 92037Zachary Manalo, Study Coordinator · Study contact · 858-246-2387 · z2manalo@health.ucsd.eduMonica Guma, M.D. · Principal investigatorMore trials in San Diego
FL
- St.Jude Clinical Research · Doral, FL 33172Shelia Linares, BSN · Study contact · 305-507-2273 · slinares@stjudeclinicalresearch.comGustavo Torres, MD · Principal investigatorMore trials in Doral
- AP Medical Research · Miami, FL 33165Simon Gomez · Study contact · 305-400-8899 · simon@apmedresearch.comIdania Fernandez, MD · Principal investigatorMore trials in Miami
- Edward Jenner Research · Plantation, FL 33317Lahari Cherukuri · Study contact · 954-676-7440 · l.cherukuri@edwardjmedicalresearch.comSteven Gelbard, MD · Principal investigatorMore trials in Plantation
PA
- Altoona Center for Research · Duncansville, PA 16635Tracey Madonna, MA · Study contact · 814-693-0300 ext. 147 · traceymadonna@altoonaresearch.comBrenda Endress · Study contact · 8146930300 ext. 202 · brendaearnest@altoonaresearch.comAlan Kivitz, MD · Principal investigatorMore trials in Duncansville
TX
- Prolato Clinical Research Center · Houston, TX 77054Amy Hutson · Study contact · 832-338-9118 · ahutson@prolato.orgMichelle Eisenberg, M.D. · Principal investigatorMore trials in Houston