An observational study in Ulcerative Colitis (Disorder), sponsored by Humanitas Clinical and Research Center. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Humanitas Clinical and Research Center · Observational
Among 209 studies in Colitis, Ulcerative with a site in Italy — 48 open to participants now, 77 under way, 27 of them phase 3. Colitis, Ulcerative · Italy.
Among the 209 studies in Colitis, Ulcerative with a site in Italy, this one is the 10th largest by planned enrollment of the 34 observational ones that give a count, is one of 18 that started in 2023, is one of 34 observational ones, reaches primary completion later than 5 of the 76 other live ones, and was the 171st registered.
1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.
Browse Colitis, Ulcerative studies →48 of the 209 studies in Colitis, Ulcerative with a site in Italy are open now. Recruiting first, the newest first:
Palisade Bio · Sites in Italy, United States, Canada and 9 more countries
Ages 18–75
Pfizer · Sites in Italy, United States, Australia and 7 more countries
Ages 2–11
Janssen Research & Development, LLC · Sites in Italy, United States, Argentina and 30 more countries
Ages 18+
Eli Lilly and Company · Sites in Italy, United States, Belgium and 7 more countries
Ages 18–80
University of Padova · Sites in Italy
Ages 18–75
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
209 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 77 · Phase 3 73 · Phase 4 9
First in 2003; this study’s year is marked. 18 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 450 is above the median of 198 across 551 observational studies indexed under Colitis, Ulcerative.
Median enrollment 182 across the 175 interventional studies, 279 across the 34 observational. Of the 122 that completed or were terminated, 74 (61%) have results posted.
This tab as a report to print or save as PDF → With an account.
153 of 209 have an industry lead sponsor. The 10 most frequent:
Humanitas Clinical and Research Center is the lead sponsor of 33 studies on the registry; 6 are open to participants now.
Humanitas Clinical and Research Center has 1 study filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
23 of the studies in Colitis, Ulcerative with a site in Italy that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589986Phase 3Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | 2027-01-30 |
| NCT06260163Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | 2027-02-10 |
| NCT04624230Phase 3PfizerEvaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | 2027-03-17 |
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
Add all 23 to your calendar (.ics) → With an account.
Among the 209 studies in Colitis, Ulcerative with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Patients with ulcerative colitis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
UC patients treated with vedolizumab
UC patients treated with ustekinumab
UC patients treated with JAK inhibitors
Clinical and endoscopic effectiveness of the three treatments
Rates of steroid-free clinical remission and endoscopic remission
Time frame: 12 months
Started Aug 2023 (actual). Primary completion is estimated for Dec 2024, 16 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Humanitas Clinical and Research Center