Ulcerative ColitisATTRACTNCT06449820
Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis
An observational study of Ulcerative Colitis and Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Inflammatory Bowel Diseases
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2024to 30 Dec 2024
- 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
- Adult, Older adult
Study population: Patients hospitalized for ulcerative colitis disease relapse and treated during their stay with JAKi (tofacitinib, filgotinib, or upadacitinib) between 01/01/2019 and 01/12/2023.
Who may be able to join
- Patient ≥ 18 years old,
- Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria,
- Hospitalisation at any point for treatment of ulcerative colitis disease relapse,
- Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay,
- Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks,
- Patient who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data.
Who cannot join
- Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,
- Receiving JAKi prior to admission,
- Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.
Trial locations and contacts
1 site in 1 country.
France1 site
Nancy University Hospital
Vandœuvre-lès-Nancy, Sélectionnez Un Département / État, 54500
About this study
Official title: Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study
Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis.
The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness
- Absence of steroid-free clinical remission according to the PRO-2 (stool ≤1 and rectal bleeding sub-score of 0)
- Use of a prohibited treatment for relapse (partial Mayo score >5)
- Severe adverse event leading to discontinuation of JAKi treatment
- Colectomy
- Death during the study period
Measured: after study completion, average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2024
- Study start24 Apr 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Laurent PEYRIN-BIROULET, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06449820
- Sponsor's protocol ID
- 2024PI030
- Acronym
- ATTRACT
- Status last verified
- May 2025
- First submitted
- 15 Apr 2024
- Last updated
- 6 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Janus Kinase Inhibitors for the Treatment of Acute Severe Ulcerative Colitis: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06449820
- Acronym / sponsor ID
- ATTRACT / 2024PI030
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 10 Jun 2024 (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.
Ulcerative colitis (UC) is an incurable, immune-mediated inflammatory disease of the large bowel that typically requires long term immunosuppressive drugs to induce and maintain remission. Hospitalisation due to severe, uncontrolled disease is a common occurrence and estimated to affect up to 25% of UC patients. Janus kinase inhibitors (JAKi) have attracted considerable attention as potential candidates for treating hospitalised patients with severe UC and are increasingly used in this setting. For tofacitinib, there are accumulating data supporting their use as effective induction agents to prevent colectomy and reduce length of hospitalisation, however, these are limited to small case series and small cohort studies only. There are no published data for the use of filgotinib and upadacitinib for treating severe inpatient colitis.
The aim of this study is to develop a large retrospective cohort of JAKi-treated hospitalised UC patients to describe the safety and effectiveness of using JAKi in this setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients hospitalized for ulcerative colitis disease relapse and treated during their stay with JAKi (tofacitinib, filgotinib, or upadacitinib) between 01/01/2019 and 01/12/2023.
Key inclusion criteria (6 listed)
- Patient ≥ 18 years old,
- Established diagnosis of ulcerative colitis as per ECCO (European Crohn´s and Colitis Organisation) criteria,
- Hospitalisation at any point for treatment of ulcerative colitis disease relapse,
- Receiving at least one dose of tofacitinib, filgotinib, or upadacitinib for the treatment of severe UC during inpatient stay,
- Endoscopically confirmed active disease (Mayo endoscopic subscore ≥ 2) within previous four weeks,
Key exclusion criteria (3 listed)
- Diagnosis of Crohn's disease or unclassified Inflammatory Bowel Disease,
- Receiving JAKi prior to admission,
- Clostridium difficile, cytomegalovirus (CMV), or other enteric infections identified on admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness
Time frame: after study completion, average of 1 month
* Absence of steroid-free clinical remission according to the PRO-2 (stool ≤1 and rectal bleeding sub-score of 0) * Use of a prohibited treatment for relapse (partial Mayo score >5) * Severe adverse event leading to discontinuation of JAKi treatment * Colectomy * Death during the study period
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 6 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ulcerative Colitis and Inflammatory Bowel Diseases, run by Central Hospital, Nancy, France at 1 site in France.
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 3 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 6 May 2025. 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 France. 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?
Treatment failure up to day 98 after JAKi initiation to describe treatment effectiveness (time frame: after study completion, average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2025.