Dose Tapering Study of Adalimumab in Psoriasis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04028713
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Ghent
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jo Lambert, Prof, dr
Principal Investigator Affiliation University Hospital, Ghent
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis Vulgaris
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Standard dosing group

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

Experimental: Dose tapering group

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

AZ Maria Middelares, Ghent, East-Flanders, Belgium

Status

Address

AZ Maria Middelares

Ghent, East-Flanders, 9000

Site Contact

Linda Temmerman, Dr

[email protected]

09 332 22 87

AZ Sint-Lucas, Ghent, East-Flanders, Belgium

Status

Address

AZ Sint-Lucas

Ghent, East-Flanders, 9000

Site Contact

Laurence Dierckxsens, Dr

[email protected]

09 332 22 87

University Hospital Ghent, Ghent, East-Flanders, Belgium

Status

Address

University Hospital Ghent

Ghent, East-Flanders, 9000

Site Contact

Jo Lambert, Prof

[email protected]

09332287 #+32

Private practice Dermatology, Maldegem, East-Flanders, Belgium

Status

Address

Private practice Dermatology

Maldegem, East-Flanders, 9990

Site Contact

Sven Lanssens

[email protected]

09 332 22 87

University Hospital Leuven, Leuven, Vlaams-Brabant, Belgium

Status

Address

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000

Site Contact

Tom Hillary, Dr

[email protected]

09 332 22 87

AZ Delta Rembert, Torhout, West-Flanders, Belgium

Status

Address

AZ Delta Rembert

Torhout, West-Flanders, 8820

Site Contact

Annelies Stockman, Dr

[email protected]

09 332 22 87

AZ Sint-Jan, Brugge, West-Vlaanderen, Belgium

Status

Address

AZ Sint-Jan

Brugge, West-Vlaanderen, 8000

Site Contact

Marleen Goeteyn, Dr

[email protected].be

09 332 22 87

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