Identifying the best treatments for rheumatoid arthritis
Innovative Trial Designs, Multi-omics and Advanced Computational Prediction to Transform Clinical Care in RA
NA · Sir Mortimer B. Davis - Jewish General Hospital · NCT05305066
This study is testing different advanced medications for rheumatoid arthritis to see which ones work best for patients who haven't had good results with standard treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05305066 on ClinicalTrials.gov |
What this trial studies
This study aims to personalize treatment for rheumatoid arthritis (RA) by identifying the most effective drug for each patient based on their specific condition and treatment history. It focuses on patients who have not responded adequately to standard treatments and are eligible for advanced therapies. The study will evaluate the effectiveness of various biologic and targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) in improving patient outcomes. By utilizing a pragmatic approach, the research seeks to enhance treatment strategies and ultimately improve the quality of life for individuals suffering from RA.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with rheumatoid arthritis and have not responded adequately to standard treatments.
Not a fit: Patients who have previously received biologic therapies or have contraindications to such treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with rheumatoid arthritis.
How similar studies have performed: Other studies have shown promise in personalizing treatment for rheumatoid arthritis, but this approach aims to refine and enhance existing strategies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years; * Arthritis that fulfills the 2010 ACR/EULAR classification criteria for RA; * Failure to standard conventional synthetic DMARDs and eligible for second-line b/tsDMARDs (Sub-study 1) or failure to at least one TNF inhibitor and eligible for third-line b/tsDMARDs (Sub-study 2). Exclusion Criteria: * Prior b/tsDMARDs for Sub-study 1 or prior b/tsDMARDs other than TNF inhibitors for Sub-study 2; * Contraindication to b/tsDMARD therapy, such as active infection or untreated latent TB, current malignancy, severe organ dysfunction, history of VTE (unless anticoagulated), high risk of cardiovascular disease, pregnancy/lactation; * Overlap with another inflammatory disease requiring specific immunosuppressive therapy, such as lupus nephritis; * Unable to provide consent or complete forms (alone or with assistance) in English or French
Where this trial is running
Montreal, Quebec
- Sir Mortimer B. Davis Jewish General Hospital — Montreal, Quebec, Canada (RECRUITING)
Study contacts
- Principal investigator: Marie Hudson, MD — Sir Mortimer B. Davis - Jewish General Hospital
- Study coordinator: Marie Hudson, MD
- Email: marie.hudson@mcgill.ca
- Phone: 514-340-8222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatoid Arthritis, Rheumatoid arthritis, Pragmatic trials, Feasibility