Not Yet RecruitingPhase 2

Combination Therapy With Infliximab and Tofacitinib for Acute Severe Ulcerative Colitis - CINTO Trial

India60 participantsStarted 2026-01-01

Plain-language summary

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

Who can participate

Age range18 Years – 65 Years

SexALL

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Exclusion criteria

✕. Patients with UC who did not meet the Truelove Witts criteria for ASUC.
✕. Patients who are already on Tofacitinib / Infliximab.
✕. Latent or active tuberculosis.
✕. 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).
✕. Pseudomembranous colitis or concomitant CMV colitis.
✕. Intestinal perforation.
✕. Massive haemorrhage requiring emergency colectomy.

What they're measuring

Clinical Remission Rate

Timeframe: Week 1 and Week 4

Trial details

NCT IDNCT07297069

SponsorAsian Institute of Gastroenterology, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-31

Contact for this trial

Vamsi Krishna Ankam, DrNB(medical gastroenterology)

+91 9705904243 Vamsiankam999@gmail.com

View on ClinicalTrials.gov More Acute Severe Ulcerative Colitis trials