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Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients (BIOLOPTIM-GUS)

Primary Purpose

Psoriasis Vulgaris

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Venapuncture
Patient questionnaires
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Therapeutic drug monitoring, Psoriasis, Guselkumab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ Maria MiddelaresRecruiting
  • AZ Sint-LucasRecruiting
  • University Hospital GhentRecruiting
  • Private practice DermatologyRecruiting
  • University HospitalRecruiting
  • AZ Sint-JanRecruiting
  • AZ Delta RembertRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Standard of case - guselkumab

Arm Description

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

Outcomes

Primary Outcome Measures

Predictive value of early serum trough concentrations of guselkumab
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.
Predictive value of early anti-drug antibodies of guselkumab
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.
Development of the therapeutic window of guselkumab in psoriasis
Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response

Secondary Outcome Measures

DLQI
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.
EQ-5D-5L
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.
EQ VAS
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.

Full Information

First Posted
July 19, 2019
Last Updated
January 16, 2023
Sponsor
University Hospital, Ghent
Collaborators
KU Leuven, University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04080648
Brief Title
Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients
Acronym
BIOLOPTIM-GUS
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
KU Leuven, University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Therapeutic drug monitoring, Psoriasis, Guselkumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
A prospective, open label, non-randomized study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of case - guselkumab
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Venapuncture
Intervention Description
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab.
Intervention Type
Other
Intervention Name(s)
Patient questionnaires
Intervention Description
The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit
Primary Outcome Measure Information:
Title
Predictive value of early serum trough concentrations of guselkumab
Description
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.
Time Frame
Week 0 until week 24 of treatment
Title
Predictive value of early anti-drug antibodies of guselkumab
Description
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.
Time Frame
Week 0 until week 24 of treatment
Title
Development of the therapeutic window of guselkumab in psoriasis
Description
Defining a therapeutic window for guselkumab based on serum trough concentrations corresponding with adequate clinical response
Time Frame
Week 0 until week 52 of treatment
Secondary Outcome Measure Information:
Title
DLQI
Description
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.
Time Frame
Week 0 until week 52 of treatment
Title
EQ-5D-5L
Description
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.
Time Frame
Week 0 until week 52 of treatment
Title
EQ VAS
Description
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.
Time Frame
Week 0 until week 52 of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Lambert, prof
Phone
09 332 22 87
Ext
+32
Email
jo.lambert@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda Grine, dr
Phone
09 332 22 87
Ext
+32
Email
lynda.grine@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, Prof.
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Temmerman, Dr
Facility Name
AZ Sint-Lucas
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Dierckxssens, Dr
Facility Name
University Hospital Ghent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, Prof
Phone
09 332 22 87
Ext
+32
Email
jo.lambert@uzgent.be
First Name & Middle Initial & Last Name & Degree
Lynda Grine, Dr
Phone
09 332 22 87
Ext
+32
Email
lynda.grine@uzgent.be
Facility Name
Private practice Dermatology
City
Maldegem
State/Province
East-Flanders
ZIP/Postal Code
9990
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Lanssens, Dr
Facility Name
University Hospital
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Hillary, Dr
Facility Name
AZ Sint-Jan
City
Brugge
State/Province
West-Flanders
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen Goeteyn, Dr
Facility Name
AZ Delta Rembert
City
Torhout
State/Province
West-Flanders
ZIP/Postal Code
8820
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Stockman, Dr

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients

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