Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints

• Register: ClinicalTrials.gov
• Last refreshed on: 27 June 2022
• Main ID: NCT04798287
• Date of registration: 11/03/2021
• Prospective Registration: No
• Primary sponsor: Brigham and Women's Hospital
• Public title: Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints STAR-RA-Cancer
• Scientific title: Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints
• Date of first enrolment: March 10, 2021
• Target sample size: 105711
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT04798287
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Seoyoung C Kim, MD, ScD, MSCE
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion 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 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)

- Diagnosis of malignant cancer prior to cohort entry date (ever look-back period)

- 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)



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tofacitinib

Drug: TNF Inhibitor

Primary Outcome(s)

Time to second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis) [Time Frame: Through study time period (2012-2020)]

Secondary Outcome(s)

Time to second outpatient or inpatient diagnosis of leukemia [Time Frame: Through study time period (2012-2020)]

Time to second outpatient or inpatient diagnosis of colorectal cancer (excluding any carcinoma in situ diagnosis) [Time Frame: Through study time period (2012-2020)]

Time to second outpatient or inpatient diagnosis of breast cancer (excluding any carcinoma in situ diagnosis) [Time Frame: Through study time period (2012-2020)]

Time to second outpatient or inpatient diagnosis of lung cancer (excluding any carcinoma in situ diagnosis) [Time Frame: Through study time period (2012-2020)]

Time to second outpatient or inpatient diagnosis of prostate cancer (excluding any carcinoma in situ diagnosis) [Time Frame: Through study time period (2012-2020)]

Time to second outpatient or inpatient diagnosis of lymphoma [Time Frame: Through study time period (2012-2020)]

Time to second outpatient or inpatient diagnosis of lymphatic/hematopoietic tissue cancers [Time Frame: Through study time period (2012-2020)]

Time to first procedure code occurring within 60 days of an outpatient or inpatient diagnosis of NMSC [Time Frame: Through study time period (2012-2020)]

Secondary ID(s)

2011P002580-207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors