Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.

NCT05291039 | Completed

• 1 other identifier: Infliximab & Adalimumab in IBD
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Inflammatory Bowel Diseases

Keywords

Infliximab; Adalimumab

Outcome Measures

Primary Outcomes (2)

• Trough concentration of ADA and IFX will be assessed after reaching steady state levels.

  Blood Level

  1 month

• myeloid cells 1 (TREM1) levels

  predictive biomarker

  1 month

Study Arms (2)

Infliximab.

ACTIVE COMPARATOR

group 1 (n=20): patients will receive IFX,

Drug: Infliximab

Adalimumab.

ACTIVE COMPARATOR

group 2 (n=20): patients will receive ADA

Drug: Adalimumab

Interventions

Infliximab DRUG

group 1 (n=20): patients will receive IFX

Also known as: IFX

Infliximab.

Adalimumab DRUG

group 2 (n=20): patients will receive ADA

Also known as: ADA

Adalimumab.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rehab Werida: lead

Study Sites (1)

Tropical Medicine department, Ain Shams University Hospitals.

Cairo, 31527, Egypt

Location

Related Publications (4)

• 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.

  PMID: 31406511 BACKGROUND

• Fluxa, D. and M.T. Abreu, Therapeutic targets in inflammatory bowel disease. Revista Médica Clínica Las Condes, 2019. 30(4): p. 315-322.

  BACKGROUND

• 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.

  PMID: 30735257 BACKGROUND

• Kamal ME, Werida RH, Radwan MA, Askar SR, Omran GA, El-Mohamdy MA, Hagag RS. Efficacy and safety of infliximab and adalimumab in inflammatory bowel disease patients. Inflammopharmacology. 2024 Oct;32(5):3259-3269. doi: 10.1007/s10787-024-01508-w. Epub 2024 Jul 10.

  PMID: 38985232 DERIVED

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Infliximab; Adalimumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized

Study Officials

• Rehab H Werida, Ass Prof.

  Damanhour University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomized controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: March 22, 2022
• Study Start: January 1, 2022
• Primary Completion: March 30, 2023
• Study Completion: April 1, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)