Clinical trial NCT05291039: Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
Official title: Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Diseases
Keywords: Infliximab
Adalimumab
Lead sponsor: Damanhour University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).
Primary purpose: TREATMENT

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 \[group 1 (n=20): patients will receive IFX\], \[group 2 (n=20): patients will receive ADA\]. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
timeFrame: 1 month
measure: myeloid cells 1 (TREM1) levels
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Tropical Medicine department, Ain Shams University Hospitals.
Study officials:
affiliation: Damanhour University
name: Rehab H Werida, Ass Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Fluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica Clínica Las Condes, 2019. 30(4): p. 315-322.
citation: 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.