Advanced Therapeutics in Rheumatoid Arthritis (RA)

Lawson Health Research Institute

Status and phase: Enrolling; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: Etanercept; Drug: tofacitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT03976245

RAJP0001

Details and patient eligibility

About

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).

Full 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).

Enrollment: 144 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

etanercept

Active Comparator group

Description:

etanercept 50 mg subcutaneously injected per week

Treatment:

Drug: Etanercept

tofacitinib

Active Comparator group

Description:

tofacitinib 5 mg orally daily

Treatment:

Drug: tofacitinib