Rheumatoid ArthritisNCT04772248
Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tofacitinib and TNF Inhibitor
- How many people
- 105,711 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There will be two independent study populations: 1. 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. 2. 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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham And Women's Hospital
Boston, Massachusetts, 02120
About this study
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tofacitinib, TNF Inhibitor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
First eligible prescription for treating rheumatoid arthritis (RA)
TNF InhibitorDrug
Also called infliximab, adalimumab, certolizumab pegol, etanercept
First eligible prescription for treating rheumatoid arthritis (RA)
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with Tofacitinib | Real-World Evidence (RWE) and RCT-Duplicate Receives: Drug: Tofacitinib | |
| Patients treated with TNF inhibitors | Real-World Evidence (RWE) and RCT-Duplicate Receives: Drug: TNF Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke
Myocardial infarction OR Stroke
Measured: Through study time period (2012-2020)
Secondary outcomes (5)
Time to myocardial infarction
Measured: Through study time period (2012-2020)
Time to stroke
Measured: Through study time period (2012-2020)
Time to heart failure hospitalization
Measured: Through study time period (2012-2020)
Time to coronary revascularization
Measured: Through study time period (2012-2020)
Time to all-cause mortality
Measured: Through study time period (2012-2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start22 Feb 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 105,711 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rishi J. Desai, Brigham and Women's Hospital
- Investigators
- Rishi Desai, MS, PhD, Principal investigator, Assistant Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772248
- Sponsor's protocol ID
- 2011P002580-202
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2021
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khosrow-Khavar F, Kim SC, Lee H, Lee SB, Desai RJ. Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study. Ann Rheum Dis. 2022 Jun;81(6):798-804. doi: 10.1136/annrheumdis-2021-221915. Epub 2022 Jan 13.
PubMed 35027405
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of TofAcitinib in Routine Care Patients With Rheumatoid Arthritis (STAR-RA)- Cardiovascular Endpoints
- ClinicalTrials.gov ID
- NCT04772248
- Acronym / sponsor ID
- 2011P002580-202
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105,711 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients treated with Tofacitinib | – | Drug: TofacitinibReal-World Evidence (RWE) and RCT-Duplicate |
| Patients treated with TNF inhibitors | – | Drug: TNF InhibitorReal-World Evidence (RWE) and RCT-Duplicate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There will be two independent study populations: 1. 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. 2. 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibFirst eligible prescription for treating rheumatoid arthritis (RA) | Drug | Patients treated with Tofacitinib |
| TNF InhibitorAlso: infliximab, adalimumab, certolizumab pegol, etanerceptFirst eligible prescription for treating rheumatoid arthritis (RA) | Drug | Patients treated with TNF inhibitors |
Primary outcome
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke
Time frame: Through study time period (2012-2020)
Myocardial infarction OR Stroke
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 35027405Khosrow-Khavar F, Kim SC, Lee H, Lee SB, Desai RJ. Tofacitinib and risk of cardiovascular outcomes: results from the Safety of TofAcitinib in Routine care patients with Rheumatoid Arthritis (STAR-RA) study. Ann Rheum Dis. 2022 Jun;81(6):798-804. doi: 10.1136/annrheumdis-2021-221915. Epub 2022 Jan 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rishi Desai, MS, PhD principal investigator
Assistant Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first composite cardiovascular endpoint consisting of myocardial infarction or stroke (time frame: Through study time period (2012-2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04772248, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.