Advanced Therapeutics in Rheumatoid Arthritis (RA)

Rheumatoid Arthritis Clinical Trial

Official title:

Advanced Therapeutics in Rheumatoid Arthritis (RA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03976245
• Other study ID #: RAJP0001
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2020
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Lawson Health Research Institute
• Contact: Janet E Pope, MD MPH
• Phone: 519 646-6000
• Email: janet.pope[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
injection
• tofacitinib
tablet

Locations

Country	Name	City	State
Canada	Rheumatology Clinic, St. Joseph's Health Care	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Academic Medical Organization of Southwestern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention Rates	Evaluation of the proportion of patients in each arm still on the randomized treatment	24 months
Secondary	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