Evaluating advanced therapies for Rheumatoid Arthritis
Advanced Therapeutics in Rheumatoid Arthritis (RA)
This study is testing whether a new type of oral medication for rheumatoid arthritis works better than a common injection treatment over two years.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Drugs / interventions | tofacitinib, methotrexate |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT03976245 on ClinicalTrials.gov |
What this trial studies
This study evaluates the retention rates of two advanced therapies, Tumour Necrosis Factor inhibitors (TNFi) and Janus kinase inhibitors (JAK), in treating adults with Rheumatoid Arthritis (RA) over a two-year period. It aims to determine if JAK inhibitors, which are small molecule oral drugs, provide better retention rates compared to TNFi, which is commonly prescribed. The study also explores the integration of clinical trials into routine clinical practice using electronic medical records. Participants will be monitored for their response to these therapies and the reasons for any discontinuation.
Who should consider this trial
Good fit: Ideal candidates include adults with active Rheumatoid Arthritis who have failed conventional therapies and meet specific clinical criteria.
Not a fit: Patients with contraindications to the study medications or those with certain serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment retention and outcomes for patients with Rheumatoid Arthritis.
How similar studies have performed: Other studies have shown varying success with advanced therapies in Rheumatoid Arthritis, but this specific comparison of TNFi and JAK inhibitors is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with RA who meet criteria for obtaining an advanced therapeutic through usual care * active RA with 5 or more swollen joints * seropositive * presence of erosions * failure of methotrexate and hydroxychloroquine and sulfasalazine * failure of Leflunomide -\> or equal to 18 years * able to provide consent * able to attend usual follow up visits Exclusion Criteria: * no contraindication to etanercept or tofacitinib * active serious infection * active Tuberculosis * multiple sclerosis * current cancer * lymphoma ever * previous use of an advanced therapeutic (biologic or JAK kinase inhibitor) * less than 18 years of age * unable to provide consent
Where this trial is running
London, Ontario
- Rheumatology Clinic, St. Joseph's Health Care — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Janet E Pope, MD MPH — Western University, Canada
- Study coordinator: Janet E Pope, MD MPH
- Email: janet.pope@sjhc.london.on.ca
- Phone: 519 646-6000
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.