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

March 24, 2026 updated by: Mary George Benyamin Tanious, Assiut University
To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Mohamed Abd Elhakim omran, Assistant literature
  • Phone Number: +20 1067663269
  • Email: Drmohhakim1@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study is a retrospective, observational study involving chart reviews of patients with inflammatory bowel disease (IBD) at Luxor International Hospital.

Description

  1. 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.

  2. Exclusion Criteria:

    1. Patients with prior biologic therapy (biologic-experienced);
    2. Patients with incomplete outcome or therapy data;
    3. Patients receiving other concomitant biologic or small-molecule therapies for other conditions, such as rheumatological diseases;
    4. Pregnant patients;
    5. Patients with intermittent suspension of therapy during the 12-month period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohamed Abaas Sabah, Professor, Assiut university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Biological Treatment for IBD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

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Dietary Supplements

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