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

ConditionAcute Severe Ulcerative Colitis

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAsian Institute of Gastroenterology, India

About this trial

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

Eligibility criteria

Qualifiers

None

Disqualifiers

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.

Trial design

Treatments tested in this trial

Infliximab
Tofacitinib

Treatment groups

60 Participants

are divided into 3 treatment groups

Sponsors and collaborators

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov