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).

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Etanercept; Drug: tofacitinib

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 Type: Interventional
• Enrollment (Estimated): 144
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Janet E Pope, MD MPH; Phone Number: 66332 519 646-6000; Email: janet.pope@sjhc.london.on.ca

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Recruiting
      • Rheumatology Clinic, St. Joseph's Health Care
      • Contact: Janet E Pope; Phone Number: 519-646-6332; Email: janet.pope@sjhc.london.on.ca
      • Principal Investigator: Janet E Pope

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Rates	Evaluation of the proportion of patients in each arm still on the randomized treatment	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Disease Activity	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.	24 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: Academic Medical Organization of Southwestern Ontario
• Investigators: Principal Investigator: Janet E Pope, MD MPH, Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Janus kinase inhibitor; Tumour Necrosis Factor
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Rheumatoid; Janus Kinase Inhibitors; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Gastrointestinal Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Protein Kinase Inhibitors; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Etanercept; Tofacitinib
• Other Study ID Numbers: RAJP0001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No