Ulcerative Colitis (Disorder)NCT06691061
The PODIUM Study - a Three-arm Comparison of Target Therapies After Anti-TNFα in Ulcerative Colitis
An observational study of Ulcerative Colitis (Disorder), run by Humanitas Clinical and Research Center at 1 site in Italy.
Trial summary
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis (Disorder)
- What is being tested?
- Vedolizumab, Ustekinumab - Standard Dosage and JAK Inhibitor
- How many people
- 450 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 31 Dec 2024
- Phase
- Observational
- 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
Study population: Patients with ulcerative colitis
Who may be able to join
- Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
- Age ≥ 18 years-old;
- Capability of expressing informed consent;
- Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
- Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
- Previous treatment with at least one anti-TNFα drug licenced for the treatment of UC (i.e., infliximab, adalimumab and/or golimumab);
- No exposure to vedolizumab, ustekinumab and JAK inhibitors before baseline;
- At least 1 follow-up visit after baseline
Who cannot join
- Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
- Age < 18 years-old;
- Incapability of expressing informed consent;
- Acute severe UC requiring hospitalization at baseline;
- No previous exposure to anti-TNFα therapies;
- Previous treatment with target therapies other than anti-TNF-α for UC before baseline;
- Ustekinumab or JAK inhibitors induction with a non-standard posology for UC.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Humanitas Research Hospital IRCSS
Mialn, Italy, 00168
Alessandro Armuzzi, 0630159357, alearmuzzi@yahoo.com
About this study
Official title: Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.
- Conditions
- Ulcerative Colitis (Disorder)
- Being tested
- Vedolizumab, Ustekinumab - Standard Dosage, JAK Inhibitor
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VedolizumabDrug
UC patients treated with vedolizumab
Ustekinumab - Standard DosageDrug
UC patients treated with ustekinumab
JAK InhibitorDrug
UC patients treated with JAK inhibitors
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and endoscopic effectiveness of the three treatments
Rates of steroid-free clinical remission and endoscopic remission
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start1 Aug 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
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 Ulcerative Colitis (Disorder)Studies of the same condition, open and under way.
- 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humanitas Clinical and Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Armuzzi, Humanitas Clinical and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691061
- Sponsor's protocol ID
- IBD-001-2023
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Privitera G, Bezzio C, Figlioli G, D'Amico F, Mendes J, Varca S, Zingone F, Rodriguez-Lago I, Onali S, Caprioli FA, Chaparro M, Barreiro-de-Acosta M, Karmiris K, Degabli NT, Dar L, Pastorelli L, Gutierrez A, Orlando A, Zabana Y, Saibeni S, Piovani D, Savarino EV, Pugliese D, Magro F, Danese S, Armuzzi A; PODIUM Study Group. Ustekinumab and Janus Kinase Inhibitors Outperform Vedolizumab as Second-Line Therapy in Anti-Tumor Necrosis Factor-Experienced Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Sep;24(9):2539-2550. doi: 10.1016/j.cgh.2026.01.017. Epub 2026 Jan 29.
PubMed 41616901
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Comparative Effectiveness of Vedolizumab, Ustekinumab and JAK Inhibitors in Patients with Ulcerative Colitis After Anti-TNFα Failure or Intolerance
- ClinicalTrials.gov ID
- NCT06691061
- Acronym / sponsor ID
- IBD-001-2023
- Conditions
- Ulcerative Colitis (Disorder)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Humanitas Clinical and Research CenterUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Nov 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.
The goal of this observational study is to compare the real-life effectiveness and safety of vedolizumab, ustekinumab and JAK inhibitors in patients with UC who had been exposed to at least one anti-TNF-alpha therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ulcerative colitis
Key inclusion criteria (8 listed)
- Established diagnosis of UC according to the current European Crohn's and Colitis Organization (ECCO) guidelines7;
- Age ≥ 18 years-old;
- Capability of expressing informed consent;
- Clinically active ulcerative colitis (cf. 'operative clinical measures', below) at baseline;
- Initiation of vedolizumab, ustekinumab or JAK inhibitors (tofacitinib, upadacitinib or filgotinib) as second-line target therapy at baseline;
Key exclusion criteria (7 listed)
- Diagnosis of Crohn's colitis, IBD-U or other gastrointestinal inflammatory conditions;
- Age < 18 years-old;
- Incapability of expressing informed consent;
- Acute severe UC requiring hospitalization at baseline;
- No previous exposure to anti-TNFα therapies;
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 |
|---|---|---|
| VedolizumabUC patients treated with vedolizumab | Drug | – |
| Ustekinumab - Standard DosageUC patients treated with ustekinumab | Drug | – |
| JAK InhibitorUC patients treated with JAK inhibitors | Drug | – |
Primary outcome
Clinical and endoscopic effectiveness of the three treatments
Time frame: 12 months
Rates of steroid-free clinical remission and endoscopic remission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Derived from this study: PubMed 41616901Privitera G, Bezzio C, Figlioli G, D'Amico F, Mendes J, Varca S, Zingone F, Rodriguez-Lago I, Onali S, Caprioli FA, Chaparro M, Barreiro-de-Acosta M, Karmiris K, Degabli NT, Dar L, Pastorelli L, Gutierrez A, Orlando A, Zabana Y, Saibeni S, Piovani D, Savarino EV, Pugliese D, Magro F, Danese S, Armuzzi A; PODIUM Study Group. Ustekinumab and Janus Kinase Inhibitors Outperform Vedolizumab as Second-Line Therapy in Anti-Tumor Necrosis Factor-Experienced Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2026 Sep;24(9):2539-2550. doi: 10.1016/j.cgh.2026.01.017. Epub 2026 Jan 29.
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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.
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 (Disorder), run by Humanitas Clinical and Research Center at 1 site in Italy.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 15 Nov 2024. 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 Italy. 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?
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?
Contact Alessandro Armuzzi (+39 02 8224 5555, alessandro.armuzzi@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and endoscopic effectiveness of the three treatments (time frame: 12 months). 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 NCT06691061, 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 15 Nov 2024.