Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
IntnsificADA
1 other identifier
interventional
20
1 country
1
Brief Summary
RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 16, 2019
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2021
CompletedJuly 23, 2021
July 1, 2021
2 years
September 16, 2019
July 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adalimumab trough level
Drug levels will be measured during 12 weeks of treatment
12 weeks
Secondary Outcomes (8)
Antibodies to Adalimumab (ADA)
12 weeks
Clinical response for Ulcerative Colitis
12 weeks
Clinical response for Ulcerative colitis
12 weeks
Clinical response for Crohn´s Disease
12 weeks
Fecal calprotectin
12 weeks
- +3 more secondary outcomes
Study Arms (2)
40mg1w
ACTIVE COMPARATORAdalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
80mg2w
ACTIVE COMPARATORAdalimumab at an administration of 80 mg every two weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
- Pregnant or lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario La Paz
Madrid, Madrd, 28046, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Dolores Martin Arranz, PhD
Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 16, 2019
First Posted
May 27, 2020
Study Start
October 1, 2019
Primary Completion
September 30, 2021
Study Completion
October 30, 2021
Last Updated
July 23, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share