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Spots Global Cancer Trial Database for Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)-Cancer Endpoints

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Trial Identification

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

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

Study ID: NCT04798287

Study Description

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.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Brigham And Women's Hospital, Boston, Massachusetts, United States

Contact Details

Name: Seoyoung C Kim, MD, ScD, MSCE

Affiliation: Brigham and Women's Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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