NCT07297069Not yet recruitingPhase 2
Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial
Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial
Source: ClinicalTrials.gov · Last updated 24 Dec 2025
Brief summary (registry, in English)
In adults hospitalized with acute severe ulcerative colitis who fail to respond to intravenous steroids, does treatment with a combination of infliximab and tofacitinib, compared with infliximab alone or tofacitinib alone, result in higher rates of early clinical remission and mucosal healing, and fewer treatment-related complications over a 10 week period
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Dec 2025
- Start date
- 1 Jan 2026
- Primary completion date
- 31 May 2027
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Diseases
- Ulcerative colitis
- NCT number
- NCT07297069
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 60
- From 1 Jan 2026 to the primary completion date, 31 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Pseudomembranous colitis or concomitant CMV colitis.
Other illness
- Latent or active tuberculosis.
- Intestinal perforation.
- Massive haemorrhage requiring emergency colectomy.
- Current diagnosis or history of thromboembolic disease patients with severe cardiorespiratory, renal or hepatic Co morbidities.
Other
- Patients with UC who did not meet the Truelove Witts criteria for ASUC.
- Patients who are already on Tofacitinib / Infliximab.
- Crohn's or Indeterminate colitis.
- Mega colon (if the diameter of the transverse colon is 5.5 cm or more, with apparent oedema of the bowel wall on plain abdominal radiographs).
- Pregnant or lactating female individuals.
Who the study is looking for
- Adult (aged 18 years to 65 years) patients hospitalised due to ASUC
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute Of Gastroenterology Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.