Advanced Therapeutics in Rheumatoid Arthritis (RA)

Phase 4

Recruiting

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: tofacitinib; Drug: Etanercept

• Registration Number: NCT03976245
• Lead Sponsor: Lawson Health Research Institute

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).

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2020-03-01
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tofacitinib	tofacitinib	tofacitinib 5 mg orally daily
etanercept	Etanercept	etanercept 50 mg subcutaneously injected per week

Primary Outcome Measures

Name	Time	Method
Retention Rates	24 months	Evaluation of the proportion of patients in each arm still on the randomized treatment

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rheumatology Clinic, St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada