Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks

  • STATUS
    Recruiting
  • days left to enroll
    43
  • participants needed
    20
  • sponsor
    Hospital Universitario La Paz
Updated on 31 July 2021
corticosteroids
adalimumab
immunosuppressive agents

Summary

RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.

Description

IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.

Details
Condition Gastroenteritis, Intestinal Diseases, Inflammatory bowel disease, Bowel Dysfunction, inflammatory bowel diseases
Treatment Adalimumab
Clinical Study IdentifierNCT04404517
SponsorHospital Universitario La Paz
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients > 18y
Intensified adalimumab regime at least 4 weeks prior to enrollment
Immunosuppressants are allowed if a stable dose for > 12w is maintained
Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained

Exclusion Criteria

Patients unable to understand study protocol, study procedures or not capacitated to give informed consent
Pregnant or lactating women
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