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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHelwan University

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

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)

Trial design

Treatments tested in this trial

  • Ustekinumab 90 mg
  • Infliximab

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators