Rheumatoid Arthritis
Conditions
Keywords
Tumour Necrosis Factor, Janus kinase inhibitor
Brief summary
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).
Detailed description
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).
Interventions
DRUGtofacitinib
tablet
DRUGEtanercept
injection
Sponsors
Academic Medical Organization of Southwestern Ontario
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pragmatic, open-label, randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention Rates | 24 months | Evaluation of the proportion of patients in each arm still on the randomized treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Disease Activity | 24 months | 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. |
Countries
Canada
Contacts
Primary ContactJanet E Pope, MD MPH
Outcome results
None listed