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Dose Tapering Study of Adalimumab in Psoriasis

NCT04028713 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-09-19

No results posted yet for this study

Summary

The optimal therapeutic serum trough level (Ctrough) of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab Ctrough above this therapeutic range did not add clinical response. Based on this therapeutic window, the introduction of dose adjustments based on Ctroughs (therapeutic drug monitoring) will be further validated in a prospective randomized-controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab Ctroughs, dose reduction is able to maintain favorable clinical outcome.

Conditions

  • Psoriasis Vulgaris

Interventions

PROCEDURE

Venapuncture

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab.

PROCEDURE

Dried blood spot

A subset of patients will sample additionally by using the dried blood sampling technique.

DRUG

Dose reduction

Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • University Ghent

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Jo Lambert, Prof, dr · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-16
Primary Completion
2022-03-22
Completion
2022-03-22

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04028713 on ClinicalTrials.gov