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New treatment option for Arthritis, Rheumatoid
Official title R-2487 in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT05961592
What this study is testing
What is R-2487 DP?
R-2487 DP is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for arthritis, rheumatoid.
Also referred to as Drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- people 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...
- people may be able to be on hydroxychloroquine, methotrexate, and leflunomide. Sulfasalazine use is not permitted.
You likely can't join if
- Pregnancy (females, unless surgically sterile or at least two years post- menopausal must have a negative serum pregnancy test within 14 days prior...
- Nursing mothers.
- people with autoimmune disease other than RA [e.g., psoriasis, systemic lupus erythematosus (SLE), vasculitis, seronegative spondylarthritis...
- people should not receive any of the following medications:
- Rituximab within 12 months prior to Day 1,
- Abatacept within 3 months prior to Day 1,
See the full eligibility criteria
Who can join
- 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.
- people 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.
- people may be able to be on hydroxychloroquine, methotrexate, and leflunomide. Sulfasalazine use is not permitted.
- people 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.
- people receiving oral corticosteroids must be on a stable dose and at the equivalent of ≤10 mg prednisone daily for at least 4 weeks. people may not receive an IM, IV or IA administration of a corticosteroid within 4...
- All male and female people 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 people who are biologically capable...
- 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).
What rules you out
- 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...
- Nursing mothers.
- people 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...
- people 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...
- Prior history of or current inflammatory joint disease other than RA (such as psoriatic arthritis, gout, reactive arthritis, Lyme disease).
- people 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...
- A history of active TB.
- people with a positive TB screening test indicative of latent TB including people currently being treated for latent tuberculosis infection (LTBI) will not be eligible for the study.
- people 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,
- people with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.),
- people with any history of infection of a joint prosthesis or artificial joint,
- people who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis),
- people 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,
- people with history of primary immunodeficiency.
- people 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.
- people 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...
- Current clinical findings of a history of a demyelinating disorder.
- New York Heart Association (NYHA) Class III or IV heart failure.
- people who have undergone a major surgical procedure within the 60 days prior to enrollment.
- people 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- Doral, Florida, United States
- Miami, Florida, United States
- Plantation, Florida, United States
- Duncansville, Pennsylvania, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Diego, California, United States; Doral, Florida, United States; Miami, Florida, United States; Plantation, Florida, United States; Duncansville, Pennsylvania, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.