Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
Study Overview
Status
Conditions
Intervention / Treatment
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
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
- 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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Cairo, Egypt, 31527
- Tropical Medicine department, Ain Shams University Hospitals.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Infliximab.
group 1 (n=20): patients will receive IFX,
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group 1 (n=20): patients will receive IFX
Other Names:
|
|
Active Comparator: Adalimumab.
group 2 (n=20): patients will receive ADA
|
group 2 (n=20): patients will receive ADA
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
Time Frame: 1 month
|
Blood Level
|
1 month
|
|
myeloid cells 1 (TREM1) levels
Time Frame: 1 month
|
predictive biomarker
|
1 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rehab H Werida, Ass Prof., Damanhour University
Publications and helpful links
General Publications
- Fluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica Clínica Las Condes, 2019. 30(4): p. 315-322.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Infliximab & Adalimumab in IBD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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