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Not yet recruiting NCT07297069

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

Phase II Interventional Acute Severe Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Infliximab, Tofacitinib.
Who it may be relevant to
Registry conditions: Acute Severe Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Combination of INFLIXIMAB With TOFACITINIB in ASUC - CINTO Trial

Overview

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

Detailed description

Acute severe ulcerative colitis (ASUC) is a life threatening manifestation of ulcerative colitis that requires urgent medical treatment and hospitalization. Despite the use of rapid induction intravenous corticosteroids, some patients fail to respond and require rescue therapy. Infliximab is commonly used as rescue treatment; however, its effectiveness may be reduced in patients with severe inflammation and hypoalbuminemia. As a result, colectomy rates for ASUC remain significant and improved early rescue strategies are needed.

Tofacitinib is an oral Janus kinase inhibitor that targets multiple cytokine pathways involved in ulcerative colitis. It has a rapid onset of action and has shown benefit in severe and steroid-refractory disease. Because infliximab and tofacitinib act on different immunologic targets, their combined use may provide complementary therapeutic effects. Emerging observational data suggest that combining a biologic agent with a small-molecule therapy may be safe and potentially more effective in patients with severe disease who are at high risk for treatment failure.

This study is designed to explore whether the combination of infliximab and tofacitinib offers greater early clinical benefit compared to infliximab alone, tofacitinib alone for adults hospitalized with ASUC who do not respond to intravenous corticosteroids.The goal is to generate preliminary data that may inform future treatment approaches aimed at improving remission rates, accelerating mucosal healing, and reducing the need for colectomy in this high risk population.

Interventions

  • Drug Infliximab
    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.
  • Drug Tofacitinib
    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.

Primary outcome measures

  • Clinical Remission Rate [Time frame: Week 1 and Week 4]
Secondary outcome measures (3)
  • Clinical Response Rate [Time frame: Week 1 and Week 4]
  • Mucosal Healing Rate [Time frame: Week 4 and Week 12]
  • Treatment Related Adverse Events [Time frame: Baseline through Week 12]

Eligibility criteria

Inclusion criteria

Adult (aged 18 years to 65 years) patients hospitalised due to ASUC

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.
  • Pregnant or lactating female individuals.
  • Current diagnosis or history of thromboembolic disease patients with severe cardiorespiratory, renal or hepatic Co morbidities.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 1 center
  • Asian Institute of Gastroenterology — Hyderabad

Publications

  • Hickman K, Jordan R, Sonnier W. Combination biologic and small molecule therapy for refractory ulcerative colitis. Gastroenterology. 2022;162(3 Suppl):S103.
  • A genome-scale CRISPR tool for targeting multiple gene family members at once. Nat Plants. 2023 Apr;9(4):511-512. doi: 10.1038/s41477-023-01388-y. No abstract available. PMID 36973416

Identifiers

NCT: NCT07297069 · CINTO 1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗