Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

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.
    

Intervention name(s): Infliximab; Adalimumab
Intervention type(s): Drug; Drug
Intervention description(s): group 1 (n=20): patients will receive IFX; group 2 (n=20): patients will receive ADA
Other intervention name(s): IFX; ADA
Intervention MeSH terms: Adalimumab; Infliximab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Infliximab; Adalimumab