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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Infliximab Plus TofacitinibExperimental treatment 2 interventions
Group B: Infliximab OnlyActive comparator 1 intervention
Group C: Tofacitinib OnlyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Remission Rate

Clinical remission is defined as defined as a Mayo score ≤2 and no individual subscore \>1.Participants meeting these criteria will be classified as achieving clinical remission.

Time frame
Week 1 and Week 4

Secondary outcomes

1

Clinical Response Rate

Reduction of baseline Mayo score by ≥3 points and a decrease of 30% from the baseline score with a decrease of at least one point on the rectal bleeding subscale or an absolute rectal bleeding score of 0 or 1.

Time frame
Week 1 and Week 4
2

Mucosal Healing Rate

Mucosal healing is defined as an endoscopic Mayo score of 0 or 1 on flexible sigmoidoscopy. Participants undergoing endoscopic evaluation who meet these criteria will be classified as achieving mucosal healing.

Time frame
Week 4 and Week 12
3

Treatment Related Adverse Events

Adverse events related to study medications, including but not limited to infections, lymphocytopenia, thromboembolic events, hyperlipidemia, and infusion or drug-related reactions, will be recorded throughout the study period. Severity and relationship to the study intervention will be assessed.

Time frame
Baseline through Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asian Institute of Gastroenterology, India

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: