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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04772248




Registration number
NCT04772248
Ethics application status
Date submitted
23/02/2021
Date registered
26/02/2021
Date last updated
2/03/2022

Titles & IDs
Public title
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
Scientific title
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
Secondary ID [1] 0 0
2011P002580-202
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib
Treatment: Drugs - TNF Inhibitor

Patients treated with Tofacitinib - Real-World Evidence (RWE) and RCT-Duplicate

Patients treated with TNF inhibitors - Real-World Evidence (RWE) and RCT-Duplicate


Treatment: Drugs: Tofacitinib
First eligible prescription for treating rheumatoid arthritis (RA)

Treatment: Drugs: TNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke
Timepoint [1] 0 0
Through study time period (2012-2020)
Secondary outcome [1] 0 0
Time to myocardial infarction
Timepoint [1] 0 0
Through study time period (2012-2020)
Secondary outcome [2] 0 0
Time to stroke
Timepoint [2] 0 0
Through study time period (2012-2020)
Secondary outcome [3] 0 0
Time to heart failure hospitalization
Timepoint [3] 0 0
Through study time period (2012-2020)
Secondary outcome [4] 0 0
Time to coronary revascularization
Timepoint [4] 0 0
Through study time period (2012-2020)
Secondary outcome [5] 0 0
Time to all-cause mortality
Timepoint [5] 0 0
Through study time period (2012-2020)

Eligibility
Key inclusion criteria
Criteria:

Please see https://www.bwhprime.org/resources.html for full code and algorithm definitions.

Eligible cohort entry dates:

- For US MarketScan, 2012-2018

- For Optum, 2012-2020

- For Medicare Claims Database (Parts A, B and D), 2012-2017

Cohort entry date:

- First TNFi or tofacitinib dispensation/administration date

Inclusion and
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria Common to RWE and RCT-duplicate Cohorts:

1. Inclusion Criteria

- Patients treated with tofacitinib or TNF inhibitors in IBM MarketScan, Optum, and
Medicare fee-for-service

- A minimum of 365 days of continuous enrollment in health plan prior to (and
including) the cohort entry date

- Two diagnosis codes for RA in any setting in 365 days baseline period (diagnosis
codes between 7 and 365 days apart)

2. Exclusion Criteria

- Index drug in 365 days prior to cohort entry date (prevalent users)

- Missing data on age or gender

- Admission to nursing facility or hospice on or prior to cohort entry date (ever
look-back)

- TNFi users with history of any Janus kinase (JAK) inhibitors (tofacitinib,
upadacitinib, or baricitinib) (ever look-back period)

- TNFi users initiating with more than one TNFi on same date

- Tofacitinib users with a prescription of baricitinib, upadacitinib (ever
look-back period)

- Tofacitinib users initiating treatment on multiple JAK inhibitors on same day
(tofacitinib and baricitinib, tofacitinib and upadacitinib)

Exclusion criteria specific to RWE cohorts:

- Patients less than 18 years of age (MarketScan and Optum) and 65 years of age
(Medicare) at cohort entry

Inclusion criteria specific to RCT-duplicate cohorts:

- Patients with at least one methotrexate dispensation (six months look-back period)

- Patients with at least one cardiovascular risk factor (including smoking,
hypertension, dyslipidemia, diabetes mellitus, ischemic heart disease, family history
of ischemic heart disease) (one-year look-back period)

Exclusion criteria specific to RCT-duplicate cohorts:

- Patients less than 50 years of age (MarketScan and Optum) and 65 years

- Patients recently hospitalized with infections (30-day look-back period)

- Pregnant patients (one year look-back period)

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/12/2021
Sample size
Target
Accrual to date
Final
105711
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Massachusetts

Funding & Sponsors
Primary sponsor type
Other
Name
Brigham and Women's Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
There are two main aims of this study.

First aim is to compare the risk of cardiovascular events (including myocardial infarction or
stroke), between patients treated with tofacitinib and patients treated with TNF inhibitors
(TNFi) for rheumatoid arthritis (RA) among, 1) "real world evidence (RWE)" cohorts including
routine care patient population from the US and, 2) "Randomized controlled trial (RCT)
DUPLICATE" cohorts including routine care patient population who meet inclusion and exclusion
criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In
Subjects With Rheumatoid Arthritis ("ORAL Surveillance", NCT02092467) clinical trial.

Second aim is to examine the risk of myocardial infarction, stroke, heart failure
hospitalization, coronary revascularization, and all-cause mortality as separate endpoints
when comparing tofacitinib with TNFi in patients with RA among, 1) "real world evidence
(RWE)" cohort including routine care patient population from the US and, 2) "Randomized
controlled trial (RCT) DUPLICATE" cohort including routine care patient population who meet
inclusion and exclusion criteria of the Safety Study Of Tofacitinib Versus Tumor Necrosis
Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis ("ORAL Surveillance",
NCT02092467) clinical trial.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04772248
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Rishi Desai, MS, PhD
Address 0 0
Assistant Professor of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries