Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05291039
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2022-03-12
Brief Title:
Infliximab and Adalimumab in Inflammatory Bowel Disease Patients
Sponsor:
Rehab Werida
Organization:
Damanhour University
Study Overview
Official Title:
Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n20 patients will receive IFX group 2 n20 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 eg BUN and creatinine iv Inflammatory Markers C-reactive protein CRP estimated sedimentation Ratio ESR
v Stool analysis WBCs RBCs 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 PMNs cryptitis infiltration of lamina propria granuloma depletion of goblet cells thickened muscularis mucosa dysplasia its 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
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 eg BUN and creatinine iv Inflammatory Markers C-reactive protein CRP estimated sedimentation Ratio ESR
v Stool analysis WBCs RBCs 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 PMNs cryptitis infiltration of lamina propria granuloma depletion of goblet cells thickened muscularis mucosa dysplasia its 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None