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Ulcerative Colitis AcutePhase 2TRIUMPHNCT04925973

Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management

A Phase 2 study testing Tofacitinib 10 MG [Xeljanz] in people with Ulcerative Colitis Acute, run by McMaster University at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis Acute
What is being tested?
Tofacitinib 10 MG [Xeljanz]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteCanada
Study dates
1 Jun 2021to Dec 2023
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • Adults ages 18 to 75 with ulcerative colitis (either known UC based on prior history with histological confirmation or new diagnosis)
  • Symptoms consistent with severe acute ulcerative colitis as defined by modified Truelove and Witts score (MTWSI) > 10 points
  • Primary non-response or secondary loss of response to anti-TNFα/anti-integrin therapies/anti-interleukin therapies OR immunomodulators OR non-response to minimum 3 days and maximum of 7 days of intravenous corticosteroids (intravenous at dose equivalent of prednisone 50mg daily / methylprednisolone 40mg daily).
  • For patients using anti-TNFα or anti-integrin or anti-interleukin therapies, they must have been on a stable dose of one of the following: i. Adalimumab in the 14 days prior to screening ii. Golimumab in the 28 days prior to screening iii. Infliximab in the 28 days prior to screening iv. Vedolizumab in the 28 days prior to screening v. Ustekinumab in the 28 days prior to screening b. Persons on biologic therapy will have drug levels drawn during the time of hospitalization
  • Able to provide written informed consent
  • Treatment with concomitant corticosteroids or 5-ASA products is permitted, however patients will be placed on a corticosteroid weaning regimen after initiating study protocols. For patients using biologics or immunomodulators, these will be discontinued prior to initiation of tofacitinib.

Who cannot join

  • Enteric infection confirmed before inclusion into study by stool microscopy, culture, or histology (including Clostridum difficile, Campylobacter, Salmonella, Shigella, Cytomegalovirus, Human Immunodeficiency Virus, Epstein Bar Virus)
  • Clinical signs of sepsis
  • Patient has indication for surgery instead of medical rescue therapy (ex. toxic megacolon, massive exsanguination, or perforation)
  • Positive blood (beta-HCG) pregnancy test or currently lactating, or women of childbearing potential not willing to use double barrier contraception for the duration of the active part of the study and for 4 weeks after the last dose of tofacitinib
  • Participants will be sufficiently educated to ensure compliance with double barrier contraception prior to enrollment in the study
  • Current malignancy
Show all 12Show fewer
  • Serious co-morbidity including but not limited to:
  • Immunodeficiency b. Recent myocardial infarction or stroke (in the past month) c. History of heart, respiratory, renal, or hepatic failure i. Heart failure as defined as ejection fraction of <50% as determined by transthoracic echo ii. Respiratory failure as defined as PaO2 <60mmHg iii. Hepatic failure as defined as INR > 2.5 with total bilirubin >30 iv. Renal failure as defined as a creatinine clearance of 40ml/min (as estimated by the Cockroft-Gault equation) d. Infections such as abscess, opportunistic infection, or sepsis
  • English not adequate in absence of local translation service
  • Currently taking part in another clinical trial
  • Treatment with tofacitinib in the 3 months prior to screening
  • Use of strong CYP (3A4 or 2C19) inhibitors or inducers such as antifungals (ketoconazole, fluconazole), St John's wort or rifampin a. Patients will be told to avoid consumption of grapefruit juice

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • McMaster University

    Hamilton, Ontario, L8S 4K1

Other trials in Canada

About this study

Official title: Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management (the TRIUMPH Study)

The TRIUMPH study was designed to build on the existing literature by studying the efficacy of tofacitinib in hospitalized patients with acute severe ulcerative colitis. This trial will provide evidence for a possible new indication for the use of tofacitinib.

Being tested
Tofacitinib 10 MG [Xeljanz]

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tofacitinib 10 MG [Xeljanz]Drug

    Tofacitinib 10mg PO BID

Study groups in NCT04925973
Study groupRoleWhat they receive
Treatment armExperimentalTofacitinib 10mg PO BID
Receives: Drug: Tofacitinib 10 MG [Xeljanz]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical response at day 7

    To determine the effectiveness (combined and endoscopic response) and safety of tofacitinib in patients with acute severe UC who experience treatment failure to steroids or anti-TNFα/anti-integrin therapies/anti-interleukin therapies. The primary outcome of this study is to assess clinical response at day 7 among patients who receive tofacitinib. This will be determined by the percentage of patients who achieve clinical response at day 7 (MTWSI reduction 3 or more points and MTWSI < 10).

    Measured: 7 days

Secondary outcomes (9)

  1. 1. Percentage of patients who achieve clinical remission at day 7, and weeks 12, 26, and 52 (Partial Mayo score < 2, with no subscore >1)

    Measured: 52 weeks

  2. Number of colectomies (emergency and planned) during the 52 weeks

    Measured: 52 weeks

  3. Number of patients requiring switch in therapy (i.e. initiation of another biological medication, start of a different clinical trial with another active drug, etc) during the 52 weeks

    Measured: 52 weeks

  4. Percentage of patients who achieve clinical response at weeks 12, 26, and 52 (MTWSI reduction 3 or more points and MTWSI < 10)

    Measured: 52 weeks

  5. For patients who have response, to determine the mean number of days before detection of clinically significant response (MTWSI reduction of 3 or more points) population.

    Measured: 7 days

  6. To determine the rate of corticosteroid-free clinical remission based on Number of patients with initial Mayo 2/3 disease at flexible sigmoidoscopy that achieve endoscopic improvement (Mayo score 0 or 1) at week 26

    Measured: Week 26

  7. Comparison of absolute change from baseline endoscopic Mayo score at week 26

    Measured: Week 26

  8. Comparison of number of patients with severe colitis based on histology who are able to achieve histological improvement (mild or inactive colitis) at week 26

    Measured: Week 26

  9. Proportion of individuals who experience a severe adverse event over the course of treatment

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2021
  2. Study start1 Jun 2021
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04925973
Sponsor's protocol ID
11428
Acronym
TRIUMPH
Status last verified
Oct 2023
First submitted
8 Jun 2021
Last updated
24 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data will be collected from study sites and analyzed.

Publications

  • Narula N, Pray C, Hamam H, Peerani F, Hansen T, Bessissow T, Bressler B, Arun A, Schmit M, Castelli J, Marshall JK. Tofacitinib for Hospitalized Acute Severe Ulcerative Colitis Management (The TRIUMPH Study). Crohns Colitis 360. 2025 Feb 15;7(1):otaf013. doi: 10.1093/crocol/otaf013. eCollection 2025 Jan.

    PubMed 40092634

  • Narula N, Hamam H, Peerani F, Bessissow T, Bressler B, Dulai PS; Canadian IBD Research Consortium; Canadian IBD Research Consortium. Resolution of Rectal Bleeding by Day 7 in Acute Severe Ulcerative Colitis Is Prognostic for Postdischarge Corticosteroid-Free Clinical Remission and Endoscopic Improvement. Am J Gastroenterol. 2024 Sep 1;119(9):1939-1942. doi: 10.14309/ajg.0000000000002860. Epub 2024 May 8.

    PubMed 38775974

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tofacitinib 10 MG [Xeljanz] in people with Ulcerative Colitis Acute, run by McMaster University at 1 site in Canada.

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 6 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 24 Oct 2023. 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 Canada. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Clinical response at day 7 (time frame: 7 days). 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 NCT04925973, which also lists 2 linked publications.

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 24 Oct 2023.

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