Dose Tapering Study of Adalimumab in Psoriasis

Psoriasis Vulgaris Clinical Trial

Official title:

A Non-inferiority Study on Dose Reduction of Adalimumab in Psoriasis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04028713
• Other study ID #: BIOLOPTIM-ADA
• Status: Terminated
• Phase: Phase 4
• Start date: February 16, 2021
• Est. completion date: March 22, 2022

Study information

• Verified date: December 2019
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Procedure:
• Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab.
• 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.

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge	West-Vlaanderen
Belgium	AZ Maria Middelares	Ghent	East-Flanders
Belgium	AZ Sint-Lucas	Ghent	East-Flanders
Belgium	University Hospital Ghent	Ghent	East-Flanders
Belgium	University Hospital Leuven	Leuven	Vlaams-Brabant
Belgium	Private practice Dermatology	Maldegem	East-Flanders
Belgium	AZ Delta Rembert	Torhout	West-Flanders

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Ghent	KU Leuven, University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical response	The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization	Week 0- Week 48
Secondary	The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.		Week 0- Week 48
Secondary	The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.		Week 0- Week 48
Secondary	Relapse	The proportion of patients in each group who relapses (defined as the need for dose escalation (not in the standard based dosing arm))	Week 0- Week 48

External Links

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