Inflammatory Bowel Diseases Clinical Trial
Official title:
Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
Verified date | March 2024 |
Source | Damanhour University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients.
Status | Completed |
Enrollment | 56 |
Est. completion date | April 1, 2023 |
Est. primary completion date | March 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Adult patients between 18 years and 80 years. 2. Patients having moderate to severe IBD according to European Crohn's and colitis organization (ECCO) guidelines. 3. IBD patients receiving either IFX or ADA. Exclusion Criteria: 1. Patients missed one-year follow-up or with missed data. 2. Patients having mild IBD according to ECCO guidelines. 3. Patients having any of the Contraindications to the biological Therapy e.g.: latent TB, viral or fungal or bacterial infection. |
Country | Name | City | State |
---|---|---|---|
Egypt | Tropical Medicine department, Ain Shams University Hospitals. | Cairo |
Lead Sponsor | Collaborator |
---|---|
Rehab Werida |
Egypt,
Fluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica Clínica Las Condes, 2019. 30(4): p. 315-322.
Seyedian SS, Nokhostin F, Malamir MD. A review of the diagnosis, prevention, and treatment methods of inflammatory bowel disease. J Med Life. 2019 Apr-Jun;12(2):113-122. doi: 10.25122/jml-2018-0075. — View Citation
Shivaji UN, Sharratt CL, Thomas T, Smith SCL, Iacucci M, Moran GW, Ghosh S, Bhala N. Review article: managing the adverse events caused by anti-TNF therapy in inflammatory bowel disease. Aliment Pharmacol Ther. 2019 Mar;49(6):664-680. doi: 10.1111/apt.15097. Epub 2019 Feb 8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Trough concentration of ADA and IFX will be assessed after reaching steady state levels. | Blood Level | 1 month | |
Primary | myeloid cells 1 (TREM1) levels | predictive biomarker | 1 month |
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