Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-27

Study Completion Date

2023-12-31

Brief Summary

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Biologic such as guselkumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of guselkumab and determine the therapeutic window of guselkumab in psoriasis patients.

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Detailed Description

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Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. In addition, Psoriasis Area and Severity Index (PASI) and Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A prospective, open label, non-randomized study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of case - guselkumab

Patients will continue to receive guselkumab according to the standard dosing schedule; subcutaneous injection of 100 mg at weeks 0 and 4 and then every 8 weeks

Group Type OTHER

Venapuncture

Intervention Type PROCEDURE

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

Patient questionnaires

Intervention Type OTHER

The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit

Interventions

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Venapuncture

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

Intervention Type PROCEDURE

Patient questionnaires

The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
2. Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Exclusion Criteria

1. Participants who have currently a predominant nonplaque form of psoriasis
2. Participants who are pregnant, nursing or planning a pregnancy
3. Participants who are unable or unwilling to undergo multiple venapunctures
4. Participants who are treated according to a different dosing schedule than standard dosing of guselkumab

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No