Biological Therapy in Patients With Inflammatory Bowel Disease
1 other identifier
observational
100
1 country
1
Brief Summary
Inflammatory bowel disease (IBD) is characterised by chronic, relapsing inflammation of the intestinal mucosa and an inability to down regulate the inflammatory immune response once activated. IBD encompasses ulcerative colitis (UC), Crohn's disease (CD) and indeterminate colitis which is not clearly diagnosed as UC or CD. The peak age of onset of IBD is 15 to 30 years, with a second smaller peak occurring between 50 and 70 years of age
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
October 31, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedOctober 31, 2022
October 1, 2022
1.1 years
October 26, 2022
October 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
quality of life in patients with IBD after biological therapy
we use The SF-36 form
one year
Interventions
to assess quality among patients with patients with IBD
Eligibility Criteria
Diagnosis of IBD will be based on combination between clinical, laboratory, radiological, endoscopic and/or histopathological data Indications of biological therapy are based on the current diagnostic and treatment recommendations of Epidemiological Committee of European Crohn's and Colitis Organization (ECCO). In most countries, moderate to severe luminal CD, or perianal or fistulising CD, or moderate to severe UC patients with immunosuppressant or corticosteroid refractory disease, or those with intolerance or contraindication to conventional therapies are eligible to be treated with biological therapy
You may qualify if:
- \- Any patient who is above age of 18 years old and diagnosed to have IBD (UC and/or CD) and eligible for biological therapy will be recruited in the study.
You may not qualify if:
- Patients with IBD who aren't eligible to biological therapy
- Pregnant patients with IBD
- Patients with IBD who are under age of 18 years old
- Patient's refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ahmed
Al Minyā, Alminya, 71515, Egypt
Related Publications (1)
Ng SC, Shi HY, Hamidi N, Underwood FE, Tang W, Benchimol EI, Panaccione R, Ghosh S, Wu JCY, Chan FKL, Sung JJY, Kaplan GG. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017 Dec 23;390(10114):2769-2778. doi: 10.1016/S0140-6736(17)32448-0. Epub 2017 Oct 16.
PMID: 29050646BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ahmed M Abu-Elfatth
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer of Tropical Medicine and Gastroenterology
Study Record Dates
First Submitted
October 26, 2022
First Posted
October 31, 2022
Study Start
November 1, 2022
Primary Completion
November 30, 2023
Study Completion
December 1, 2023
Last Updated
October 31, 2022
Record last verified: 2022-10