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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04798287
Other study ID # 2011P002580-207
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 10, 2021
Est. completion date May 16, 2022

Study information

Verified date June 2022
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

There are two main aims of this study. First aim is to compare the risk of composite cancer outcomes, 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 common solid cancers (lung, colorectal, breast, prostate), hematological cancers, and non-melanoma skin cancer as separated 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.


Recruitment information / eligibility

Status Completed
Enrollment 105711
Est. completion date May 16, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tofacitinib
First eligible prescription for treating rheumatoid arthritis (RA)
TNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)

Locations

Country Name City State
United States Brigham And Women's Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis) Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of lung cancer (excluding any carcinoma in situ diagnosis) Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of colorectal cancer (excluding any carcinoma in situ diagnosis) Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of breast cancer (excluding any carcinoma in situ diagnosis) Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of prostate cancer (excluding any carcinoma in situ diagnosis) Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of lymphatic/hematopoietic tissue cancers Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of lymphoma Through study time period (2012-2020)
Secondary Time to second outpatient or inpatient diagnosis of leukemia Through study time period (2012-2020)
Secondary Time to first procedure code occurring within 60 days of an outpatient or inpatient diagnosis of NMSC Through study time period (2012-2020)
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