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NCT06786507Active, not recruiting

A Direct Head-to-head Comparison of Ustekinumab With Infliximab for the Treatment of Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 17 Sept 2026

Brief summary (registry, in English)

the goal of this study is to compare the efficacy of ustekinumab with infliximab for the treatment of ulcerative colitis aim of the study : 1. Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients. 2. Compare safety of ustekinumab therapy versus infliximab therapy in UC 3. To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
9 Jan 2025
Start date
15 May 2025
Primary completion date
12 Dec 2027
Lead sponsor
Helwan University
NCT number
NCT06786507

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 15 May 2025 to the primary completion date, 12 Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \- Previous exposure to IFX or UST or any other in IFX or UST-containing product

Other illness

  • Has a history of hypersensitivity or allergies to the ingredients of IFX or UST formulations
  • Unstable angina
  • Moderate or severe heart failure (defined as New York Heart Association Class III or IV)
  • Chronic respiratory failure
  • History of any major neurological disorders including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease
  • Chronic hepatitis B or C infection. Patients with positive viral serology at screening for infection with hepatitis B (HBV) or hepatitis C virus (HCV) may be eligible if the polymerase chain reaction test is negative, and the patients receive standard of-care antiviral prophylaxis (if applicable)
  • Known severe chronic kidney failure
  • Known severe chronic liver failure
  • Known active or latent tuberculosis
  • Ongoing HIV infection

Who the study is looking for

  • Subjects who are voluntarily able to give informed consent
  • Subjects who can participate in all aspects of this clinical study
  • Males and females aged from ≥ 18 to ≤ 80 years, at screening visit
  • Diagnosis of moderate to severe UC established by clinical and endoscopic evidence.
  • Biological therapy naïve patients.

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
El-Demerdash hospital
Coordinator of this site? Confirm its status
CairoEgyptUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.