Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.

Sponsor
Rehab Werida
Study ID
NCT05291039
Status
Completed

Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Infliximab — DRUG
    group 1 (n=20): patients will receive IFX
  • Adalimumab — DRUG
    group 2 (n=20): patients will receive ADA

Study Details

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

Key Dates

Start date
Jan 1, 2022
Status verified
Mar 2024
Primary completion
Mar 30, 2023
Completion
Apr 1, 2023

Study Design

Enrollment
56 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Infliximab.
    group 1 (n=20): patients will receive IFX,
  • Active Comparator: Adalimumab.
    group 2 (n=20): patients will receive ADA

Primary Outcome Measure

Trough concentration of ADA and IFX will be assessed after reaching steady state levels. [ Time Frame: 1 month ]

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