NCT03976245

Advanced Therapeutics in Rheumatoid Arthritis (RA)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Etanercept	injection
DRUG	tofacitinib	tablet

Timeline

• Start date: 2020-03-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2019-06-05
• Last updated: 2024-11-29

Locations

1 site across 1 country: Canada