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

Sponsor
Hospital Universitario La Paz
Study ID
NCT04404517
Phase
PHASE3
Status
Unknown

Conditions

  • Inflammatory Bowel Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Monoclonal antibody used in IBD treatment

Study Details

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

Key Dates

Start date
Oct 1, 2019
Status verified
Jul 2021
Primary completion
Sep 30, 2021
Completion
Oct 30, 2021

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: 40mg1w
    Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks
  • Active Comparator: 80mg2w
    Adalimumab at an administration of 80 mg every two weeks

Primary Outcome Measure

Adalimumab trough level [ Time Frame: 12 weeks ]

Central Contacts

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