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Advanced Therapeutics in Rheumatoid Arthritis (RA)

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03976245
Collaborator
Academic Medical Organization of Southwestern Ontario (Other)
144
Enrollment
1
Location
2
Arms
36
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Pragmatic, open-label, randomized trialPragmatic, open-label, randomized trial
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Advanced Therapeutics in Rheumatoid Arthritis (RA)
Actual Study Start Date :
Mar 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: etanercept

etanercept 50 mg subcutaneously injected per week

Drug: Etanercept
injection
Other Names:
  • enbrel
  • Brenzys

    		•
    Active Comparator: tofacitinib

    tofacitinib 5 mg orally daily

    Drug: tofacitinib
    tablet
    Other Names:
  • Xeljanz
  • Jakvinus

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Retention Rates [24 months]

      Evaluation of the proportion of patients in each arm still on the randomized treatment

    Secondary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 TB

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheumatology Clinic, St. Joseph's Health Care London Ontario Canada N6A 4V2

    Sponsors and Collaborators

    • Lawson Health Research Institute
    • Academic Medical Organization of Southwestern Ontario

    Investigators

    • Principal Investigator: Janet E Pope, MD MPH, University of Western Ontario, Canada

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT03976245
    Other Study ID Numbers:
    • RAJP0001
    First Posted:
    Jun 5, 2019
    Last Update Posted:
    May 11, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lawson Health Research Institute
    Tumour Necrosis Factor
    Janus kinase inhibitor
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid
    Etanercept
    Tofacitinib

    Study Results

    No Results Posted as of May 11, 2022