Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
144 participants
INTERVENTIONAL
2020-03-01
2025-03-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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etanercept
etanercept 50 mg subcutaneously injected per week
Etanercept
injection
tofacitinib
tofacitinib 5 mg orally daily
tofacitinib
tablet
Interventions
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Etanercept
injection
tofacitinib
tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Academic Medical Organization of Southwestern Ontario
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
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Principal Investigators
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Janet E Pope, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
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Rheumatology Clinic, St. Joseph's Health Care
London, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RAJP0001
Identifier Type: -
Identifier Source: org_study_id