Recruiting

Rheumatoid Arthritis

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03976245

Conditions

Rheumatoid Arthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Etanercept

tofacitinib

Study Details

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).

Conditions

Rheumatoid Arthritis

Study ID

NCT03976245

Start date

Mar 1, 2020

Status verified date

Nov, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Mar, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: etanercept

etanercept 50 mg subcutaneously injected per week

active comparator: tofacitinib

tofacitinib 5 mg orally daily

Interventions

Etanercept

injection

tofacitinib

tablet

Primary outcome measure

  • Retention Rates [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Janet E Pope, MD MPH

519 646-6000janet.pope@sjhc.london.on.ca

Locations

Rheumatology Clinic, St. Joseph's Health Care

Recruiting

London, Ontario, Canada, N6A 4V2

Contacts

Janet E Pope

519-646-6332janet.pope@sjhc.london.on.ca

Principal Investigator:

Janet E Pope

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Nov 29, 2024

Last verified

Nov, 2024

Keywords

  • Tumour Necrosis Factor
  • Janus kinase inhibitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2024-11-29.