R-2487 in Patients With Rheumatoid Arthritis
ConditionArthritis, Rheumatoid
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRise Therapeutics LLC
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Rituximab within 12 months prior to Day 1,
Trial design
Design model
Single group
Treatments tested in this trial
R-2487 DP
DrugProbiotic
Treatment groups
73 Participants
are divided into 3 treatment groupsGroup A: Four (4) week open label dose for Rheumatoid Arthritis patientsExperimental treatment 1 intervention
Group B: Six (6) week open label dose for Rheumatoid Arthritis patientsExperimental treatment 1 intervention
Group C: Four (4) week open label dose for Rheumatoid Arthritis with Secondary Sjorgrens Syndrome patientsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
To assess the number of participants with treatment-related adverse events after taking R-2487 (probiotic)
Time frame
Baseline through week 4Secondary outcomes
1
Change in Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)
Change from Baseline in Disease Activity Score-28 joint C- Reactive Protein (DAS28-CRP) Score at Week 6 Describes severity of rheumatoid arthritis using clinical and laboratory data in swollen and tender joints. A score between 0 to 10 with the higher number indicating more active disease.
Time frame
Baseline through week 42
Change in Simplified Disease Activity Index (SDAI) Score over time
Baseline Simplified Disease Activity Index (SDAI) Score over time. The Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: tender and swollen joint count (based on a 28-joint assessment), patient and physician global assessment of disease activity \[visual analogue scale (VAS) 0-10 cm\] and level of C-reactive protein (mg/dl, normal \<1 mg/dl).
Time frame
Baseline through week 4Sponsors and contacts
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Source ClinicalTrials.gov