Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04772248
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2021-02-23
Brief Title:
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis STAR-RA- Cardiovascular Endpoints
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis STAR-RA- Cardiovascular Endpoints
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None