Dose Tapering Study of Adalimumab in Psoriasis

NCT04028713 | Terminated Phase 4

• 1 other identifier: BC-03439
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 7

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.

Conditions

Psoriasis Vulgaris

Keywords

Therapeutic drug monitoring; Psoriasis; Adalimumab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.

  Week 0- Week 48

• The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.

  Week 0- Week 48

• Relapse

  Week 0- Week 48

Study Arms (2)

Standard dosing group

ACTIVE COMPARATOR

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

Procedure: Venapuncture; Procedure: Dried blood spot

Dose tapering group

EXPERIMENTAL

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

Procedure: Venapuncture; Procedure: Dried blood spot; Drug: Dose reduction

Interventions

Venapuncture PROCEDURE

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

Dose tapering group; Standard dosing group

Dried blood spot PROCEDURE

A subset of patients will sample additionally by using the dried blood sampling technique.

Dose tapering group; Standard dosing group

Dose reduction DRUG

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

Dose tapering group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• KU Leuven: collaborator
• University Ghent: collaborator

Study Sites (7)

AZ Maria Middelares

Ghent, East-Flanders, 9000, Belgium

Location

AZ Sint-Lucas

Ghent, East-Flanders, 9000, Belgium

Location

University Hospital Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Private practice Dermatology

Maldegem, East-Flanders, 9990, Belgium

Location

University Hospital Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ Delta Rembert

Torhout, West-Flanders, 8820, Belgium

Location

AZ Sint-Jan

Bruges, West-Vlaanderen, 8000, Belgium

Location

Related 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.

  PMID: 35683398 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

Dried Blood Spot Testing; Drug Tapering

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Jo Lambert, Prof, dr

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized non-inferiority study

Study Record Dates

• First Submitted: July 19, 2019
• First Posted: July 23, 2019
• Study Start: February 16, 2021
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (7)