Infliximab and Adalimumab in Irritable Bowel Disease Patients.

Sponsor

Rehab Werida (Other)

Overall Status

Recruiting

CT.gov ID

NCT05291039

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel Disease	Drug: Infliximab Drug: Adalimumab	N/A

Detailed Description

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 Irritable Bowel Disease (IBD).
Study procedure

Laboratory investigations

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)

Kidney function tests e.g BUN and creatinine. iv. Inflammatory Markers (C-reactive protein (CRP), estimated sedimentation Ratio (ESR)).
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.

TREM-1 levels will be measured for all patients.

Endoscopic intervention
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)
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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).

Masking:

Double (Participant, Investigator)

Masking Description:

Randomized controlled

Primary Purpose:

Treatment

Official Title:

Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Irritable Bowel Disease Patients.

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 30, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Infliximab. group 1 (n=20): patients will receive IFX,	Drug: Infliximab group 1 (n=20): patients will receive IFX Other Names: IFX
Active Comparator: Adalimumab. group 2 (n=20): patients will receive ADA	Drug: Adalimumab group 2 (n=20): patients will receive ADA Other Names: ADA

Arm

Intervention/Treatment

Active Comparator: Infliximab.

group 1 (n=20): patients will receive IFX,

Drug: Infliximab

group 1 (n=20): patients will receive IFX

Other Names:

IFX

Active Comparator: Adalimumab.

group 2 (n=20): patients will receive ADA

Drug: Adalimumab

group 2 (n=20): patients will receive ADA

Other Names:

ADA

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult patients between 18 years and 80 years.
Patients having moderate to severe IBD according to European Crohn's and colitis organization (ECCO) guidelines.
IBD patients receiving either IFX or ADA.

Exclusion Criteria:

Patients missed one-year follow-up or with missed data.
Patients having mild IBD according to ECCO guidelines.
Patients having any of the Contraindications to the biological Therapy e.g.: latent TB, viral or fungal or bacterial infection.