Clinical trial NCT03976245: Advanced Therapeutics in Rheumatoid Arthritis (RA)
Official title: Advanced Therapeutics in Rheumatoid Arthritis (RA)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Tumour Necrosis Factor
Janus kinase inhibitor
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Academic Medical Organization of Southwestern Ontario
First posted: 2019-06-05
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic, open-label, randomized trial
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Retention Rates
timeFrame: 24 months
Secondary outcomes:
measure: Mean Change in Disease Activity
timeFrame: 24 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Rheumatology Clinic, St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Janet E Pope, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: