Advanced Therapeutics in Rheumatoid Arthritis (RA)

NCT03976245 | Recruiting Phase 4

• 1 other identifier: RAJP0001
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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

Keywords

Tumour Necrosis Factor; Janus kinase inhibitor

Outcome Measures

Primary Outcomes (1)

• Retention Rates

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

  24 months

Secondary Outcomes (1)

• Mean Change in Disease Activity

  24 months

Study Arms (2)

etanercept

ACTIVE COMPARATOR

etanercept 50 mg subcutaneously injected per week

Drug: Etanercept

tofacitinib

ACTIVE COMPARATOR

tofacitinib 5 mg orally daily

Drug: tofacitinib

Interventions

Etanercept DRUG

injection

Also known as: enbrel, Brenzys

etanercept

tofacitinib DRUG

tablet

Also known as: Xeljanz, Jakvinus

tofacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Academic Medical Organization of Southwestern Ontario: collaborator

Study Sites (1)

Rheumatology Clinic, St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; tofacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Janet E Pope, MD MPH

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Janet E Pope, MD MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pragmatic, open-label, randomized trial

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: March 1, 2020
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)