Advanced Therapeutics in Rheumatoid Arthritis (RA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Etanercept, tofacitinib.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Etanercept
injection - Drug tofacitinib
tablet
Primary outcome measures
- Retention Rates [Time frame: 24 months]
Secondary outcome measures (1)
- Mean Change in Disease Activity [Time frame: 24 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Rheumatology Clinic, St. Joseph's Health Care — London
Identifiers
NCT: NCT03976245 · RAJP0001