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Clinical trial

Assessment of Trough Levels and Efficacy of Infliximab and Adalimumab in Inflammatory Bowel Disease Patients.

ID
Name
Infliximab & Adalimumab in IBD
Description
This study aims to assess trough, TREM-1 levels and efficacy of IFX and ADA in IBD patients.
Trial arms
Trial start
2022-01-01
Estimated PCD
2023-03-30
Trial end
2023-04-01
Status
Completed
Treatment
Infliximab
group 1 (n=20): patients will receive IFX
Arms:
Infliximab.
Other names:
IFX
Adalimumab
group 2 (n=20): patients will receive ADA
Arms:
Adalimumab.
Other names:
ADA
Size
56
Primary endpoint
Trough concentration of ADA and IFX will be assessed after reaching steady state levels.
1 month
myeloid cells 1 (TREM1) levels
1 month
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective study for IBD patients receiving either adalimumab (group 1) or infliximab (group 2).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Randomized controlled'}}, 'enrollmentInfo': {'count': 56, 'type': 'ACTUAL'}}
Updated at
2024-03-28

1 organization

2 products

1 indication

Organization
Rehab Werida
Product
Infliximab
Indication
Inflammatory Bowel Disease
Product
Adalimumab