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

NCT06786507 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: ustekinumab with infliximab
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Compare effectiveness of ustekinumab versus infliximab therapy in remission achievement in UC patients.
2. 2.Compare safety of ustekinumab therapy versus infliximab therapy in UC
3. 3.To asses quality of life of ustekinumab therapy versus infliximab therapy in UC patients.

Conditions

Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (2)

• (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)

  baseline and after 6 months

• safety evaluation

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

  baseline and after 6 months

Secondary Outcomes (1)

• improvement in quality of life

  baseline and after 6 months

Study Arms (2)

arm A is infliximab

for induction patients in this group will receive infliximab in week 0,2,6 for maintenance they will receive the drug every 8 weeks dose for both induction and maintenance is 5mg/kg IV

Drug: Infliximab

arm B is ustekinomab

for induction patients in this group will receive an IV infusion with a weight based dose for maintenance they will receive a SC injection with a fixed dose 90mg every 8 weeks

Drug: Ustekinumab 90 mg

Interventions

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

arm B is ustekinomab

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

arm A is infliximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

moderate to severe ulcerative colitis bio naïve patients

You may qualify if:

• 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.

You may not qualify if:

• \- 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)
• 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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

El-Demerdash hospital

Cairo, Egypt

Location

Related Links

• McDowell C, Farooq U, Haseeb M. Inflammatory Bowel Disease. \[Updated 2022 Jun 27\]. In: StatPearls \[Internet\]. Treasure Island (FL): StatPearls Publishing; 2023 Jan.
• Alatab, S., Sepanlou, S. G., Ikuta, K., Vahedi, H., Bisignano, C., Safiri, S. ... \& Alipour, V. (2020). The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the
• Elbadry M, Nour MO, Hussien M, Ghoneem EA, Medhat MA, Shehab H, Galal S, Eltabbakh M, El-Raey F, Negm M, Afify S, Abdelhamed W, Sherief A, Abdelaziz A, Abo Elkasem M, Mahrous A, Kamal G, Maher M, Abdel-Hameed O, Elbasuny A, El-Zayyadi I, Bassiony A,
• Mosli, M., Alawadhi, S., Hasan, F., Abou Rached, A., Sanai, F., \& Danese, S. (2021). Incidence, Prevalence, and Clinical Epidemiology of Inflammatory Bowel Disease in the Arab World: A Systematic Review and Meta-Analysis. Inflammatory intestinal dise
• Le Berre, C., Honap, S., \& Peyrin-Biroulet, L. (2023). Ulcerative colitis. Lancet (London, England), 402(10401), 571-584.
• Singh, S. Murad,M , Fumery M , Dulai ,P.S . Sandborn W .J.First- and Second-Line Pharmacotherapies for Patients With Moderate to Severely Active Ulcerative Colitis: An Updated Network Meta-Analysis Clinical Gastroenterology and Hepatology, Volume 18,
• Akiho H, Yokoyama A, Abe S, Nakazono Y, Murakami M, Otsuka Y, Fukawa K, Esaki M, Niina Y, Ogino H. Promising biological therapies for ulcerative colitis: A review of the literature. World J Gastrointest Pathophysiol. 2015 Nov 15;6(4):219-27.
• You Y, Stelzl P, Joseph DN, Aldo PB, Maxwell AJ, Dekel N, Liao A, Whirledge S, Mor G. TNF-α Regulated Endometrial Stroma Secretome Promotes Trophoblast Invasion. Front Immunol. 2021;12:737401.
• Benson JM, Peritt D, Scallon BJ, Heavner GA, Shealy DJ, Giles-Komar JM, Mascelli MA. Discovery and mechanism of ustekinumab: a human monoclonal antibody targeting interleukin-12 and interleukin-23 for treatment of immune-mediated disorders. MAbs. 201
• Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C., UNIFI Study Group. Ustekinumab as Induction and Maintenance The

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Ustekinumab; Infliximab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at Pharmacy Practice Department Faculty of Pharmacy - Helwan University

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 22, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

EG (1)