A Phase 4 interventional study of Etanercept and tofacitinib in Rheumatoid Arthritis, sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Phase 4, Interventional, and Treatment
This study will evaluate the retention rates of two advanced therapies, Tumour Necrosis Factor (TNF) and Janus kinase inhibitor (JAK) in the treatment of adults with Rheumatoid Arthritis (RA) over a two year period. It will also examine the ability to embed a clinical trial in a clinical situation using an electronic medical record (EMR).
Conventional therapies for Rheumatoid Arthritis (RA) treatment include nonsteroidal anti-inflammatory drugs (NSAIDs), cyclooxygenase-2 (COX-2) selective inhibitors, corticosteroids and disease modifying anti-rheumatic drugs (DMARDs). These therapies are often partially effective.
For those patients, where conventional therapies have failed to alleviate their symptoms, Tumour Necrosis Factor (TNFis) is often prescribed to treat the pain and inflammation associated with RA. The main problem with TNFi and other advanced therapies in RA is retention. At least ¼ of patients stop treatment within a year and another ⅕ to ¼ in the second year, mostly due to secondary loss of efficacy.
Another advanced therapy, the Janus kinase inhibitor (JAK) has demonstrated similar efficacy to TNFi treatment in RA. This trial will determine if using a different class of treatment (small molecule, oral drug, JAK kinase inhibitor) will have a better retention than a TNFi (using the most commonly prescribed TNFi for RA in Canada).
2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.
This study's planned enrollment of 144 is above the median of 94 across 2,027 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's is the lead sponsor of 327 studies on the registry; 132 are open to participants now.
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failure of Leflunomide
-> or equal to 18 years
Exclusion Criteria:
etanercept 50 mg subcutaneously injected per week
Drug: Etanercept
tofacitinib 5 mg orally daily
Drug: tofacitinib
injection
Also known as: enbrel, Brenzys
tablet
Also known as: Xeljanz, Jakvinus
Retention Rates
Evaluation of the proportion of patients in each arm still on the randomized treatment
Time frame: 24 months
Mean Change in Disease Activity
The mean change from baseline in the Clinical Disease Activity Index in each arm of the study. The Clinical Disease Activity Index measures the number of tender or swollen joints, patient global assessment of disease activity, and provider global assessment of disease activity. Total tender joint count=0-28, total swollen joint count=0-28, patient global score=0-10, provider global score=0-10. Total range score=0-76. Higher values for all subscales, tender and swollen joints, global assessments indicate higher disease activity. Scores for subscales are combined to calculate the total score.
Time frame: 24 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2020 (actual). Primary completion is estimated for Mar 2025, 60 months after the start.
Of 71 non-industry phase 4 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 92. This study's planned 60 months is above that.
Counting every sponsor, half of 96 studies reached it within 43 months; a quarter within 25 and three quarters within 74.
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Studies of the drugs tested here: Etanercept · Tofacitinib
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's →