Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)NCT07495644
Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
An observational study of Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Assiut University.
Trial summary
To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
- What is being tested?
- adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a retrospective, observational study involving chart reviews of patients with inflammatory bowel disease (IBD) at Luxor International Hospital.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt
Read the 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.
- Being tested
- adalimumab, infliximab, ustekinumab, golimumab, and vedolizumab
- Keywords
- Ulcerative colitis, Crohn's disease
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adalimumab, infliximab, ustekinumab, golimumab, and vedolizumabBiological
Efficacy of different biological treatment on patient with inflammatory bowel disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary George Benyamin Tanious, Assiut University
- Investigators
- Mohamed Abaas Sabah, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495644
- Sponsor's protocol ID
- Biological Treatment for IBD
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Jin Y, Lin Y, Lin LJ, Zheng CQ. Meta-analysis of the effectiveness and safety of vedolizumab for ulcerative colitis. World J Gastroenterol. 2015 May 28;21(20):6352-60. doi: 10.3748/wjg.v21.i20.6352.
PubMed 26034371Osterman MT, Lichtenstein GR. Infliximab in fistulizing Crohn's disease. Gastroenterol Clin North Am. 2006 Dec;35(4):795-820. doi: 10.1016/j.gtc.2006.09.007.
PubMed 17129814Vermeire S, Gils A, Accossato P, Lula S, Marren A. Immunogenicity of biologics in inflammatory bowel disease. Ther Adv Gastroenterol. 2018 Jan 21;11:1756283X17750355. doi: 10.1177/1756283X17750355. eCollection 2018.
PubMed 29383030Laredo C, Rodriguez A, Oleaga L, Hernandez-Perez M, Renu A, Puig J, Roman LS, Planas AM, Urra X, Chamorro A. Adjunct Thrombolysis Enhances Brain Reperfusion following Successful Thrombectomy. Ann Neurol. 2022 Nov;92(5):860-870. doi: 10.1002/ana.26474. Epub 2022 Aug 23.
PubMed 36054449Alulis S, Vadstrup K, Borsi A, Nielsen A, Rikke Jorgensen T, Qvist N, Munkholm P. Treatment patterns for biologics in ulcerative colitis and Crohn's disease: a Danish Nationwide Register Study from 2003 to 2015. Scand J Gastroenterol. 2020 Mar;55(3):265-271. doi: 10.1080/00365521.2020.1726445. Epub 2020 Mar 2.
PubMed 32116064Neurath MF. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014 May;14(5):329-42. doi: 10.1038/nri3661. Epub 2014 Apr 22.
PubMed 24751956Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
PubMed 17653185Biskup L, Semeradt J, Rogowska J, Chort W, Durko L, Malecka-Wojciesko E. New Interleukin-23 Antagonists' Use in Crohn's Disease. Pharmaceuticals (Basel). 2025 Mar 22;18(4):447. doi: 10.3390/ph18040447.
PubMed 40283885GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.
PubMed 31648971
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
- ClinicalTrials.gov ID
- NCT07495644
- Acronym / sponsor ID
- Biological Treatment for IBD
- Keywords
- Ulcerative colitis, Crohn's disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a retrospective, observational study involving chart reviews of patients with inflammatory bowel disease (IBD) at Luxor International Hospital.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adalimumab, infliximab, ustekinumab, golimumab, and vedolizumabEfficacy of different biological treatment on patient with inflammatory bowel disease | Biological | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Background: PubMed 26034371Jin Y, Lin Y, Lin LJ, Zheng CQ. Meta-analysis of the effectiveness and safety of vedolizumab for ulcerative colitis. World J Gastroenterol. 2015 May 28;21(20):6352-60. doi: 10.3748/wjg.v21.i20.6352.
- Background: PubMed 17129814Osterman MT, Lichtenstein GR. Infliximab in fistulizing Crohn's disease. Gastroenterol Clin North Am. 2006 Dec;35(4):795-820. doi: 10.1016/j.gtc.2006.09.007.
- Background: PubMed 29383030Vermeire S, Gils A, Accossato P, Lula S, Marren A. Immunogenicity of biologics in inflammatory bowel disease. Ther Adv Gastroenterol. 2018 Jan 21;11:1756283X17750355. doi: 10.1177/1756283X17750355. eCollection 2018.
- Background: PubMed 36054449Laredo C, Rodriguez A, Oleaga L, Hernandez-Perez M, Renu A, Puig J, Roman LS, Planas AM, Urra X, Chamorro A. Adjunct Thrombolysis Enhances Brain Reperfusion following Successful Thrombectomy. Ann Neurol. 2022 Nov;92(5):860-870. doi: 10.1002/ana.26474. Epub 2022 Aug 23.
- Background: PubMed 32116064Alulis S, Vadstrup K, Borsi A, Nielsen A, Rikke Jorgensen T, Qvist N, Munkholm P. Treatment patterns for biologics in ulcerative colitis and Crohn's disease: a Danish Nationwide Register Study from 2003 to 2015. Scand J Gastroenterol. 2020 Mar;55(3):265-271. doi: 10.1080/00365521.2020.1726445. Epub 2020 Mar 2.
- Background: PubMed 24751956Neurath MF. Cytokines in inflammatory bowel disease. Nat Rev Immunol. 2014 May;14(5):329-42. doi: 10.1038/nri3661. Epub 2014 Apr 22.
- Background: PubMed 17653185Xavier RJ, Podolsky DK. Unravelling the pathogenesis of inflammatory bowel disease. Nature. 2007 Jul 26;448(7152):427-34. doi: 10.1038/nature06005.
- Background: PubMed 40283885Biskup L, Semeradt J, Rogowska J, Chort W, Durko L, Malecka-Wojciesko E. New Interleukin-23 Antagonists' Use in Crohn's Disease. Pharmaceuticals (Basel). 2025 Mar 22;18(4):447. doi: 10.3390/ph18040447.
- Background: PubMed 31648971GBD 2017 Inflammatory Bowel Disease Collaborators. The global, regional, and national burden of inflammatory bowel disease in 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet Gastroenterol Hepatol. 2020 Jan;5(1):17-30. doi: 10.1016/S2468-1253(19)30333-4. Epub 2019 Oct 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Abaas Sabah, Professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary George Benyamin Tanious, Resident physician (+20 1555227403, meromary2111998@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of different biological treatment on patient with inflammatory bowel disease after one year of treatment in upper egypt (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495644, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.