Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
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ClinicalTrials.gov Identifier: NCT04772248 |
Recruitment Status :
Completed
First Posted : February 26, 2021
Last Update Posted : March 2, 2022
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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.
Condition or disease | Intervention/treatment |
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Rheumatoid Arthritis | Drug: Tofacitinib Drug: TNF Inhibitor |
Study Type : | Observational |
Actual Enrollment : | 105711 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
Official Title: | Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints |
Actual Study Start Date : | February 22, 2021 |
Actual Primary Completion Date : | December 30, 2021 |
Actual Study Completion Date : | December 30, 2021 |

Group/Cohort | Intervention/treatment |
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Patients treated with Tofacitinib
Real-World Evidence (RWE) and RCT-Duplicate
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Drug: Tofacitinib
First eligible prescription for treating rheumatoid arthritis (RA) |
Patients treated with TNF inhibitors
Real-World Evidence (RWE) and RCT-Duplicate
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Drug: TNF Inhibitor
First eligible prescription for treating rheumatoid arthritis (RA)
Other Names:
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- Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke [ Time Frame: Through study time period (2012-2020) ]Myocardial infarction OR Stroke
- Time to myocardial infarction [ Time Frame: Through study time period (2012-2020) ]
- Time to stroke [ Time Frame: Through study time period (2012-2020) ]
- Time to heart failure hospitalization [ Time Frame: Through study time period (2012-2020) ]
- Time to coronary revascularization [ Time Frame: Through study time period (2012-2020) ]
- Time to all-cause mortality [ Time Frame: Through study time period (2012-2020) ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
There will be two independent study populations:
- Real-World Evidence (RWE) cohorts: This study population will reflect the patients diagnosed with RA who are routinely treated and managed in setting of clinical practice.
- RCT-duplicate cohorts: This study population will emulate "the Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis" clinical trial ("ORAL Surveillance", NCT02092467). The inclusion and exclusion criteria of this RCT will be applied to this study population.
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:
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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)
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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)
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04772248
United States, Massachusetts | |
Brigham And Women's Hospital | |
Boston, Massachusetts, United States, 02120 |
Principal Investigator: | Rishi Desai, MS, PhD | Assistant Professor of Medicine |
Documents provided by Rishi J. Desai, Brigham and Women's Hospital:
Responsible Party: | Rishi J. Desai, Assistant Professor of Medicine, Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT04772248 |
Other Study ID Numbers: |
2011P002580-202 |
First Posted: | February 26, 2021 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adalimumab Etanercept Golimumab Tumor Necrosis Factor Inhibitors Infliximab Certolizumab Pegol Tofacitinib |
Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |