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This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients.
1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University 2. All participants agree to take part in this clinical study, will agree to provide an informed written consent 3. Patients will be divided into 2 treatment groups [group 1 (n=20): patients will receive IFX], [group 2 (n=20): patients will receive ADA]. 4. Statistical tests appropriate to the study will be conducted to evaluate significance of results 5. Results, conclusion, discussion and recommendations will be given
Type of Study: prospective study for IBD patients receiving either adalimumab or infliximab.
Study Setting: The Inflammatory Bowel disease outpatient clinic, Tropical Medicine department, Ain Shams University Hospitals.
Sample Size: Study will be conducted on 40 patients with Inflammatory Bowel Disease (IBD).
Study procedure
Laboratory investigations
a) At baseline, all patients will be subjected to i. full history taking regarding: Loss of appetite, abdominal pain, number of motions, bleeding per rectum, number of attacks per year, need for hospitalization per year, Loss of weight, extra intestinal manifestations, anemic manifestations, drug history, ii. Testing the viral markers (HCV Ab, HBs Ag, HB core IgG, HIV) and Tuberculine test or Quantifferon test. (To Exclude latent TB) b) At Baseline and in follow ups, patient will be assessed for the following laboratory investigations: i. Complete blood count (CBC). ii. Liver profile (albumin, INR, total & direct bilirubin, AST, ALT) iii. Kidney function tests e.g BUN and creatinine. iv. Inflammatory Markers (C-reactive protein (CRP), estimated sedimentation Ratio (ESR)).
v. Stool analysis (WBC's, RBC's, Parasite) vi. Stool culture and sensitivity. vii. Urine analysis. c) Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
d) TREM-1 levels will be measured for all patients.
Endoscopic intervention
Efficacy and safety Assessments
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab. | Active Comparator | group 1 (n=20): patients will receive IFX, |
|
| Adalimumab. | Active Comparator | group 2 (n=20): patients will receive ADA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | group 1 (n=20): patients will receive IFX |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough concentration of ADA and IFX will be assessed after reaching steady state levels. | Blood Level | 1 month |
| myeloid cells 1 (TREM1) levels | predictive biomarker | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rehab H Werida, Ass Prof. | Damanhour University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tropical Medicine department, Ain Shams University Hospitals. | Cairo | 31527 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31406511 | Background | 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. | |
| Background | Fluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica ClÃnica Las Condes, 2019. 30(4): p. 315-322. | ||
| 30735257 |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).
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Randomized controlled
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| Adalimumab | Drug | group 2 (n=20): patients will receive ADA |
|
|
| Background |
| 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. |
| 38985232 | Derived | Kamal ME, Werida RH, Radwan MA, Askar SR, Omran GA, El-Mohamdy MA, Hagag RS. Efficacy and safety of infliximab and adalimumab in inflammatory bowel disease patients. Inflammopharmacology. 2024 Oct;32(5):3259-3269. doi: 10.1007/s10787-024-01508-w. Epub 2024 Jul 10. |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D061067 | Antibodies, Monoclonal, Humanized |