Advanced Therapeutics in Rheumatoid Arthritis (RA)
Primary Purpose
Rheumatoid Arthritis
Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Etanercept
tofacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Tumour Necrosis Factor, Janus kinase inhibitor
Eligibility Criteria
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
Sites / Locations
- Rheumatology Clinic, St. Joseph's Health CareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
etanercept
tofacitinib
Arm Description
etanercept 50 mg subcutaneously injected per week
tofacitinib 5 mg orally daily
Outcomes
Primary Outcome Measures
Retention Rates
Evaluation of the proportion of patients in each arm still on the randomized treatment
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03976245
First Posted
June 3, 2019
Last Updated
October 3, 2023
Sponsor
Lawson Health Research Institute
Collaborators
Academic Medical Organization of Southwestern Ontario
1. Study Identification
Unique Protocol Identification Number
NCT03976245
Brief Title
Advanced Therapeutics in Rheumatoid Arthritis (RA)
Official Title
Advanced Therapeutics in Rheumatoid Arthritis (RA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
Collaborators
Academic Medical Organization of Southwestern Ontario
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Tumour Necrosis Factor, Janus kinase inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Pragmatic, open-label, randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
etanercept
Arm Type
Active Comparator
Arm Description
etanercept 50 mg subcutaneously injected per week
Arm Title
tofacitinib
Arm Type
Active Comparator
Arm Description
tofacitinib 5 mg orally daily
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
enbrel, Brenzys
Intervention Description
injection
Intervention Type
Drug
Intervention Name(s)
tofacitinib
Other Intervention Name(s)
Xeljanz, Jakvinus
Intervention Description
tablet
Primary Outcome Measure Information:
Title
Retention Rates
Description
Evaluation of the proportion of patients in each arm still on the randomized treatment
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Mean Change in Disease Activity
Description
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.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet E Pope, MD MPH
Phone
519 646-6000
Ext
66332
Email
janet.pope@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet E Pope, MD MPH
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rheumatology Clinic, St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet E Pope
Phone
519-646-6332
Email
janet.pope@sjhc.london.on.ca
First Name & Middle Initial & Last Name & Degree
Janet E Pope
12. IPD Sharing Statement
Plan to Share IPD
No
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Advanced Therapeutics in Rheumatoid Arthritis (RA)
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