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Dose Tapering Study of Adalimumab in Psoriasis

Primary Purpose

Psoriasis Vulgaris

Status
Terminated
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Venapuncture
Dried blood spot
Dose reduction
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, Adalimumab

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 for at least 6 months prior to inclusion
  2. Participants must have a stable disease during maintenance on adalimumab (absolute PASI < 3)
  3. Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48).
  4. 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 while enrolled in the study or within 12 weeks after receiving the last administration of study intervention
  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 adalimumab (regular dose regimen every 2 weeks; 40 mg)

Sites / Locations

  • AZ Maria Middelares
  • AZ Sint-Lucas
  • University Hospital Ghent
  • Private practice Dermatology
  • University Hospital Leuven
  • AZ Delta Rembert
  • AZ Sint-Jan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard dosing group

Dose tapering group

Arm Description

Patients will continue to receive adalimumab according to the standard dosing schedule.

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

Outcomes

Primary Outcome Measures

Clinical response
The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization

Secondary Outcome Measures

The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.
The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.
Relapse
The proportion of patients in each group who relapses (defined as the need for dose escalation (not in the standard based dosing arm))

Full Information

First Posted
July 19, 2019
Last Updated
December 19, 2022
Sponsor
University Hospital, Ghent
Collaborators
KU Leuven, University Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT04028713
Brief Title
Dose Tapering Study of Adalimumab in Psoriasis
Official Title
A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
Too slow inclusion rate.
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)

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
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.
Detailed Description
Patients will be included after signing informed consent and randomized in either a standard dose arm or a concentration based arm based on prior Ctrough measurements. In the concentration based arm, dosing frequency will be lowered to once every 3 weeks. If patients still have supratherapeutic Ctroughs of adalimumab, these patients will continue adalimumab self-administration every 4 weeks. In the standard based arm, patients will continue on standard dosing schedule. During each study visit blood will be taken in order to quantify Ctroughs. 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. In addition, in a subset of patients in each treatment arm, additional sampling will be collected by dried blood spot sampling in order to build a PK(PD) model for adalimumab.

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, Adalimumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A randomized non-inferiority study
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard dosing group
Arm Type
Active Comparator
Arm Description
Patients will continue to receive adalimumab according to the standard dosing schedule.
Arm Title
Dose tapering group
Arm Type
Experimental
Arm Description
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
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 adalimumab.
Intervention Type
Procedure
Intervention Name(s)
Dried blood spot
Intervention Description
A subset of patients will sample additionally by using the dried blood sampling technique.
Intervention Type
Drug
Intervention Name(s)
Dose reduction
Intervention Description
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
Primary Outcome Measure Information:
Title
Clinical response
Description
The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization
Time Frame
Week 0- Week 48
Secondary Outcome Measure Information:
Title
The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.
Time Frame
Week 0- Week 48
Title
The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.
Time Frame
Week 0- Week 48
Title
Relapse
Description
The proportion of patients in each group who relapses (defined as the need for dose escalation (not in the standard based dosing arm))
Time Frame
Week 0- Week 48

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 for at least 6 months prior to inclusion Participants must have a stable disease during maintenance on adalimumab (absolute PASI < 3) Participants are not allowed to use topical steroids from 7 days before randomization until the end of the study (week 48). 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 while enrolled in the study or within 12 weeks after receiving the last administration of study intervention Participants who are unable or unwilling to undergo multiple venapunctures Participants who are treated according to a different dosing schedule than standard dosing of adalimumab (regular dose regimen every 2 weeks; 40 mg)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, Prof, dr
Organizational Affiliation
University Hospital, 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
Facility Name
AZ Sint-Lucas
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Facility Name
University Hospital Ghent
City
Ghent
State/Province
East-Flanders
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Private practice Dermatology
City
Maldegem
State/Province
East-Flanders
ZIP/Postal Code
9990
Country
Belgium
Facility Name
University Hospital Leuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Delta Rembert
City
Torhout
State/Province
West-Flanders
ZIP/Postal Code
8820
Country
Belgium
Facility Name
AZ Sint-Jan
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35683398
Citation
Soenen R, Stove C, Capobianco A, De Schutter H, Dobbelaere M, Mahjor T, Follens M, Lambert J, Grine L. Promising Tools to Facilitate the Implementation of TDM of Biologics in Clinical Practice. J Clin Med. 2022 May 26;11(11):3011. doi: 10.3390/jcm11113011.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/35683398/
Description
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Dose Tapering Study of Adalimumab in Psoriasis

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