Infliximab and Adalimumab in Irritable Bowel Disease Patients.

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    40
  • sponsor
    Rehab Werida
Updated on 12 April 2022
adalimumab
infliximab
enteropathy
colitis

Summary

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

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 Irritable Bowel Disease (IBD).
    • Study procedure
      1. Laboratory investigations
        1. 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)).
      2. 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.
      3. TREM-1 levels will be measured for all patients.
      4. Endoscopic intervention
      5. 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)
      6. 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.

Details
Condition Irritable Bowel Disease
Treatment Infliximab, Adalimumab
Clinical Study IdentifierNCT05291039
SponsorRehab Werida
Last Modified on12 April 2022

Eligibility

Yes No Not Sure

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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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