Status:
UNKNOWN
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
Lead Sponsor:
Hospital Universitario La Paz
Conditions:
Inflammatory Bowel Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
- Pregnant or lactating women.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04404517
Start Date
October 1 2019
End Date
October 30 2021
Last Update
July 23 2021
Active Locations (1)
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1
Hospital Universitario La Paz
Madrid, Madrd, Spain, 28046