Your session is about to expire
← Back to Search
Probiotic
Probiotic R-2487 for Rheumatoid Arthritis (R-2487-RA01 Trial)
Phase 1
Recruiting
Research Sponsored by Rise Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through week 4
Awards & highlights
R-2487-RA01 Trial Summary
This trial will determine if probiotic (R-2487) is safe and effective for treating Rheumatoid Arthritis in patients: effects will be measured through blood, fecal tests, and clinical assessments.
Who is the study for?
Adults aged 18-75 with active Rheumatoid Arthritis, not pregnant or nursing, who agree to use birth control and avoid vaccinations during the study. Participants must have a certain level of disease activity and can be on some RA medications but must have stopped others for specified times before joining.Check my eligibility
What is being tested?
The trial is testing R-2487, an oral probiotic, for safety and effectiveness in treating Rheumatoid Arthritis. Patients' symptoms will be monitored through blood tests and assessments of inflammation in the body.See study design
What are the potential side effects?
While specific side effects are not listed here, common side effects from probiotics may include digestive discomfort such as gas or bloating. Since this is a trial to determine safety, monitoring for any adverse reactions is part of the process.
R-2487-RA01 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through week 4
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through week 4
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events and their relationship to R-2487 (probiotic) administration
Secondary outcome measures
Change in Disease Activity Score-28 Joint C-Reactive Protein (DAS28-CRP)
Change in Simplified Disease Activity Index (SDAI) Score over time
R-2487-RA01 Trial Design
1Treatment groups
Experimental Treatment
Group I: Open LabelExperimental Treatment1 Intervention
Probiotic
Find a Location
Who is running the clinical trial?
Rise Therapeutics LLCLead Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had active tuberculosis in the past.I stopped taking certain RA medications like tofacitinib a month ago.I am between 18 and 75 years old.I will not get any vaccines during the study, including flu or COVID shots.I have more than 3 tender and swollen joints and a CDAI score over 10.I've been on a stable dose of oral steroids, not more than 10 mg of prednisone daily, for at least 4 weeks.I have an autoimmune disease like lupus or psoriasis, or active fibromyalgia.I am taking hydroxychloroquine, methotrexate, or leflunomide, but not sulfasalazine.I have or had joint inflammation not caused by rheumatoid arthritis.I haven't taken any immune system treatments or steroids for at least 30 days.I do not have latent tuberculosis or am not being treated for it.I have active rheumatoid arthritis and meet the ACR/EULAR 2010 criteria.I am at risk for TB and have recent tests or x-rays to prove it.I haven't taken specific immune-related medications recently.
Research Study Groups:
This trial has the following groups:- Group 1: Open Label
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to enlist in this medical research?
"Candidates for this rheumatoid arthritis trial must be between 18 and 75 years of age. A total of 36 subjects are being sought by the research team."
Answered by AI
Is R-2487 an acceptable therapeutic option with minimal risk?
"The safety profile of R-2487 is rated 1 due to the limited clinical evidence available, as this drug is currently in Phase 1 trials."
Answered by AI
Are recruitment efforts underway for this trial?
"Clinicaltrials.gov verifies that this trial is not currently open for patient recruitment. Initially posted on November 1st 2023 and last updated on July 18th 2023, this study has yet to resume the search for participants; however, there are an abundance of other clinical trials welcoming patients at present."
Answered by AI
Does this scientific research include participants who are thirty or older?
"The requirements for inclusion in this clinical trial is an age between 18 and 75. For those below the legal age of consent, there are 53 separate studies while 340 trials cater to seniors over 65 years old."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger