Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.

Not Applicable

Completed

• Conditions: Inflammatory Bowel Diseases
• Interventions: Drug: Infliximab; Drug: Adalimumab

• Registration Number: NCT05291039
• Lead Sponsor: Rehab Werida

Brief Summary

This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients.

Detailed Description

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

1. 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.

2. Endoscopic intervention

1. Colonoscopy with terminal ileoscopy with assessment according to Mayo score (loss of vascular pattern, presence of polyps, opacity of mucosa, bleeding on touch, excess exudates, diffuse ulceration, masses, pseudo polyps, site of involvement, linear ulcers, cobblestone appearance, conclusion)

2. Histopathological examination: (aggregates of PMN's, cryptitis, infiltration of lamina propria, granuloma, depletion of goblet cells, thickened muscularis mucosa, dysplasia \& it's degree, malignancy)

Efficacy and safety Assessments

* Target response will be measured according to mucosal healing, ESR and CRP then patients will be reassessed by ECCO guidelines.

* Safety of drugs will be assessed by the monthly follow up of CBC, Liver functions and kidney functions.

* Patients will be asked for the occurrence of any sides in the monthly follow up visits.

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-03-12
• Study First Submitted QC: 2022-03-12
• Study First Posted: 2022-03-22
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infliximab.	Infliximab	group 1 (n=20): patients will receive IFX,
Adalimumab.	Adalimumab	group 2 (n=20): patients will receive ADA

Primary Outcome Measures

Name	Time	Method
Trough concentration of ADA and IFX will be assessed after reaching steady state levels.	1 month	Blood Level
myeloid cells 1 (TREM1) levels	1 month	predictive biomarker

Trial Locations

Locations (1)

Tropical Medicine department, Ain Shams University Hospitals.; 🇪🇬 Cairo, Egypt