Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial
Phase 2 · Testing Infliximab and Tofacitinib · 1 site · Asian Institute of Gastroenterology, India
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Infliximab (a drug) and Tofacitinib (a drug) as a possible treatment. Condition(s) listed: Acute Severe Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- Adult (aged 18 years to 65 years) patients hospitalised due to ASUC
There are also 10 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 60 participants are expected to take part.
- Start date: 2026-01-01 (planned).
- Main results expected around 2027-05-31 (estimate from the record).
- 1 study site listed in India.
Main thing being measured
- Clinical Remission Rate (Week 1 and Week 4)
In the researchers’ words
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
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Acute Severe Ulcerative Colitis |
| Lead sponsor | Asian Institute of Gastroenterology, India |
| Enrollment | 60 (estimated) |
| Start date | 2026-01-01 |
| Primary completion (est.) | 2027-05-31 |
| First posted | 2025-12-22 |
| Last updated | 2025-12-24 |
| Official title | Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial |
| ClinicalTrials.gov ID | NCT07297069 |
Interventions
- Infliximab (Drug)
Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive infliximab as rescue therapy. Infliximab 300 mg will be administered intravenously. This arm evaluates the effectiveness and safety of infliximab monotherapy in inducing early clinical remission and mucosal healing. - Tofacitinib (Drug)
Participants with acute severe ulcerative colitis who do not respond to intravenous corticosteroids will receive tofacitinib as rescue therapy. Tofacitinib will be administered orally at 10 mg twice daily. This arm assesses the effectiveness and safety of tofacitinib monotherapy in inducing early clinical remission and mucosal healing.
Full eligibility criteria (from the record)
Inclusion Criteria: Adult (aged 18 years to 65 years) patients hospitalised due to ASUC Exclusion Criteria: 1. Patients with UC who did not meet the Truelove Witts criteria for ASUC. 2. Patients who are already on Tofacitinib / Infliximab. 3. Latent or active tuberculosis. 4. Crohn's or Indeterminate colitis. 5. 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). 6. Pseudomembranous colitis or concomitant CMV colitis. 7. Intestinal perforation. 8. Massive haemorrhage requiring emergency colectomy. 9. Pregnant or lactating female individuals. 10. Current diagnosis or history of thromboembolic disease patients with severe cardiorespiratory, renal or hepatic Co morbidities.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Asian Institute of Gastroenterology | Hyderabad, Telangana | India |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.