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NCT Number: NCT07495644

Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt

To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

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Key information

About this study

Inflammatory bowel disease (IBD), including Crohn's disease and ulcerative colitis, is a chronic inflammatory disorder that requires long-term management. Biological therapies have significantly improved outcomes in patients with moderate to severe disease; however, variability in treatment response remains a challenge.

This study aims to evaluate and compare the efficacy of different biological treatments in patients with IBD in Upper Egypt after one year of therapy. Clinical outcomes, including disease activity and remission rates, will be assessed to determine treatment effectiveness.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria: 1) Age ≥ 18 years; 2) Patients with moderate-to-severe ulcerative colitis, defined as a clinical Mayo score >6 with an endoscopic score of 2-3 3) Patients with moderate-to-severe Crohn's disease, defined as a Crohn's Disease Activity Index (CDAI) >220 with a Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥7 4) Patients receiving adalimumab, infliximab, ustekinumab, or vedolizumab; 5) Patients who had been on the current biologic therapy for between 6 weeks and 12 months; and 6) Biologic-naïve patients (no prior biologic therapy). Patients who did not continue their treatment for 12 months due to primary or secondary treatment failure will be considered not to have achieved endoscopic remission. Additionally, patients who were hospitalized, received corticosteroids, or underwent surgery due to medication failure before 12 months of therapy will be considered treatment failures.
  • Exclusion Criteria:
  • Patients with prior biologic therapy (biologic-experienced);
  • Patients with incomplete outcome or therapy data;
  • Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases;
  • Pregnant patients;
  • Patients with intermittent suspension of therapy during the 12-month period.

Treatment and study plan

adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab

Biological

Efficacy of different biological treatment on patient with inflammatory bowel disease

Primary outcomes

  1. Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

    Time frame: 1 year

    The primary endpoints of this study are the percentages of hospitalization, surgery, corticosteroid-free remission, and endoscopic remission in patients with inflammatory bowel disease receiving biological therapies at week 52. Patients will be considered on corticosteroids if they received a course of prednisolone, budesonide, or any other steroid medication more than six weeks after initiating the current biological therapy, excluding the induction corticosteroid course, and those who did not receive any steroid courses after this period will be considered in corticosteroid-free remission. Endoscopic remission is defined as the number of patients achieving endoscopic remission, with an Endoscopic Mayo score of 0-1 for ulcerative colitis and a Simple Endoscopic Score for Crohn's Disease (SES-CD) of 0-2 for .Surgical outcomes include patients who underwent IBD-related surgeries six weeks or more after starting the current biologic for an IBD-related issue or complications

Study contacts

Contact information is provided by the study sponsor or research team.

Mary George Benyamin Tanious, Resident physician

CONTACT

[email protected]

+20 1555227403

Mohamed Abd Elhakim omran, Assistant literature

CONTACT

[email protected]

+20 1067663269

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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