r-2487 in patients with rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

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 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.

Keywords: arthritis, rheumatoid