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Completed

NCT Number: NCT04080648

Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients

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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Key information

Conditions

Psoriasis Vulgaris Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AZ Maria Middelares, Ghent, East-Flanders, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
  • 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

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

Treatment and study plan

Venapuncture

Procedure

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

Patient questionnaires

Other

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

Primary outcomes

  1. Predictive value of early serum trough concentrations of guselkumab

    Time frame: Week 0 until week 24 of treatment

    Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.

  2. Predictive value of early anti-drug antibodies of guselkumab

    Time frame: Week 0 until week 24 of treatment

    Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies of guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.

  3. Development of the therapeutic window of guselkumab in psoriasis

    Time frame: Week 0 until week 52 of treatment

    Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response

Secondary outcomes

  1. DLQI

    Time frame: Week 0 until week 52 of treatment

    The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to evaluated overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leasure, 4) work or school performances, 5) personal relationships, and 6) treatment.

    The scoring of each question is as follows:

    Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

  2. EQ-5D-5L

    Time frame: Week 0 until week 52 of treatment

    The EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  3. EQ VAS

    Time frame: Week 0 until week 52 of treatment

    The EQ VAS (Visual Analogue Scale) (range 0-10) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • KU Leuven
  • University Ghent

Registry information

Official study title

Evaluation of the Preditive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Guselkumab and the Development of the Concentration-response Curve of Guselkumab for Psoriasis Patients.

Acronym: BIOLOPTIM-GUS

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 6, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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