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

ConditionUlcerative Colitis (UC)
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

This trial does not accept healthy volunteers

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 population

moderate to severe ulcerative colitis bio naïve patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ustekinumab 90 mg

    Drug

    Ustekinumab is a human monoclonal IgG1 antibody that blocks the p40 subunit of both IL-12 and IL-23 this antagonistic action inhibits the interaction of these cytokines with the IL-12Rβ1 receptor. The IL-12Rβ1 receptor is found on the surface of NK cells and T cells which reduces inflammation and alters the body's immune response

  • Infliximab

    Drug

    Infliximab is a biological therapy/immunotherapy medication designed to stimulate the body's immune system and treat certain diseases. Infliximab is a purified, recombinant DNA-derived chimeric IgG monoclonal antibody protein that contains both murine and human components that inhibit tumor necrosis factor-alpha (TNF-α). TNF-α is a signaling protein involved in acute phase reactions and systemic inflammation. Macrophages, CD4+ lymphocytes, NK cells, neutrophils, mast cells, eosinophils, and neurons produce TNF-α. This TNF-α inhibition inhibits the inflammatory reaction's cascade, leading to improved disease condition inflammatory bowel disease

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: arm A is infliximab1 intervention
Group B: arm B is ustekinomab1 intervention

Trial outcomes

Primary outcomes

1

(CRP) and Improvement degree of ulcerative colitis

Efficacy that will be evaluated by: Degree of reduction in the level of inflammatory markers (CRP), Improvement degree of ulcerative colitis ( ≤5 mg/l)

Time frame
baseline and after 6 months
2

safety evaluation

Any adverse event will be reported by the patient for safety evaluation of both drugs will be analyzed.

Time frame
baseline and after 6 months

Secondary outcomes

1

improvement in quality of life

improvement in quality of life using IBDQ 32 Secondary outcome definitions :The scores of patients range from 170 to 190.

Time frame
baseline and after 6 months

Other outcomes

Sponsors and contacts

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

Helwan University

Lead sponsor

Source ClinicalTrials.gov

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