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Rheumatoid ArthritisSTAR-RA-CancerNCT04798287

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

An observational study of Rheumatoid Arthritis, run by Brigham and Women's Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… 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
10 Mar 2021to 16 May 2022
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

Other trials in United States

About this study

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.

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 groups in NCT04798287
Study groupRoleWhat they receive
Patients treated with TofacitinibReal-World Evidence (RWE) and RCT-Duplicate
Receives: Drug: Tofacitinib
Patients treated with TNF inhibitorsReal-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.

  1. Time to second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis)

    Measured: Through study time period (2012-2020)

Secondary outcomes (8)

  1. Time to second outpatient or inpatient diagnosis of lung cancer (excluding any carcinoma in situ diagnosis)

    Measured: Through study time period (2012-2020)

  2. Time to second outpatient or inpatient diagnosis of colorectal cancer (excluding any carcinoma in situ diagnosis)

    Measured: Through study time period (2012-2020)

  3. Time to second outpatient or inpatient diagnosis of breast cancer (excluding any carcinoma in situ diagnosis)

    Measured: Through study time period (2012-2020)

  4. Time to second outpatient or inpatient diagnosis of prostate cancer (excluding any carcinoma in situ diagnosis)

    Measured: Through study time period (2012-2020)

  5. Time to second outpatient or inpatient diagnosis of lymphatic/hematopoietic tissue cancers

    Measured: Through study time period (2012-2020)

  6. Time to second outpatient or inpatient diagnosis of lymphoma

    Measured: Through study time period (2012-2020)

  7. Time to second outpatient or inpatient diagnosis of leukemia

    Measured: Through study time period (2012-2020)

  8. Time to first procedure code occurring within 60 days of an outpatient or inpatient diagnosis of NMSC

    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.

  1. First posted15 Mar 2021
  2. Study start10 Mar 2021
  3. Primary completion31 Dec 2021
  4. Study completion16 May 2022

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04798287
Sponsor's protocol ID
2011P002580-207
Acronym
STAR-RA-Cancer
Status last verified
Jun 2022
First submitted
11 Mar 2021
Last updated
22 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 35643956

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 22 Jun 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 second outpatient or inpatient diagnosis of any cancer (excluding NMSC and any carcinoma in situ diagnosis) (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 NCT04798287, 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 22 Jun 2022.

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