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

NCT ID: NCT04798287

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 105711 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2022-05-16

Brief 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.

Conditions

Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patients treated with Tofacitinib

Real-World Evidence (RWE) and RCT-Duplicate

Tofacitinib

Intervention Type: DRUG

First eligible prescription for treating rheumatoid arthritis (RA)

Patients treated with TNF inhibitors

Real-World Evidence (RWE) and RCT-Duplicate

TNF Inhibitor

Intervention Type: DRUG

First eligible prescription for treating rheumatoid arthritis (RA)

Interventions

Tofacitinib

First eligible prescription for treating rheumatoid arthritis (RA)

Intervention Type: DRUG

TNF Inhibitor

First eligible prescription for treating rheumatoid arthritis (RA)

Intervention Type: DRUG

Other Intervention Names

infliximab; adalimumab; certolizumab pegol; etanercept; golimumab

Eligibility Criteria

Inclusion Criteria

• 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

• 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)

• 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

• 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)

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

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Seoyoung C. Kim

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Seoyoung C Kim, MD, ScD, MSCE

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham And Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Khosrow-Khavar F, Desai RJ, Lee H, Lee SB, Kim SC. Tofacitinib and Risk of Malignancy: Results From the Safety of Tofacitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA) Study. Arthritis Rheumatol. 2022 Oct;74(10):1648-1659. doi: 10.1002/art.42250. Epub 2022 Sep 1.

Reference Type: DERIVED

PMID: 35643956 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

2011P002580-207

Identifier Type: -

Identifier Source: org_study_id