Adalimumab Trough Concentrations in Crohn's Disease: A Pilot Pharmacokinetic Study

Sponsor
Universitaire Ziekenhuizen KU Leuven
Study ID
NCT02450513
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards

Study Details

Observational pharmacokinetics study of adalimumab in patients with active refractory Crohn's disease who are naïve to TNF antagonist therapy.

Key Dates

Start date
Mar 31, 2012
Status verified
Jul 2024
Primary completion
May 25, 2016
Completion
May 25, 2016

Study Design

Enrollment
30 participants (actual)

Arms

  • Arm: Single-group study
    Subjects with active refractory Crohn's disease naïve to TNF antagonists starting adalimumab therapy.

Primary Outcome Measure

Proportion of patients in clinical remission [ Time Frame: week 12 ]

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