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NCT Number: NCT03976245

Advanced Therapeutics in Rheumatoid Arthritis (RA)

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).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location status: Recruiting

Location contact

Janet E Pope

CONTACT

[email protected]

519-646-6332

Janet E Pope

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

etanercept

Drug

injection

Other names: enbrel, Brenzys

tofacitinib

Drug

tablet

Other names: Xeljanz, Jakvinus

Primary outcomes

  1. Retention Rates

    Time frame: 24 months

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

Secondary outcomes

  1. Mean Change in Disease Activity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Janet E Pope, MD MPH

CONTACT

[email protected]

519 646-6000 ext. 66332

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Academic Medical Organization of Southwestern Ontario

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2019
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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