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

NCT05683054 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-01-12

No results posted yet for this study

Summary

Recently, the optimal therapeutic serum trough level range of adalimumab was defined between 3,5 and 7,0 µg/ml in patients with plaque type psoriasis. An adalimumab serum through level above this therapeutic range did not add to clinical response. Based on this therapeutic window, the introduction of dose adjustments based on serum trough levels (therapeutic drug monitoring) will be further validated in a prospective controlled trial. Here, we aim to determine whether, in patients with a good clinical response and supratherapeutic adalimumab STLs, dose reduction based on therapeutic drug monitoring (TDM) is able to maintain the initial clinical outcome.

Conditions

Interventions

BIOLOGICAL

Dose tapering of adalimumab in patients with supratheurapeutic serum trough levels

In the dose tapering arm, adalimumab dosing frequency will be lowered to 40 mg every 3 weeks in patients who have supratherapeutic serum trough levels of adalimumab (33% reduction). If patients still have a good clinical response and supratherapeutic adalimumab serum trough levels, will be further tapered to a dose regimen of 1 subcutaneous injection (40mg) every 4 weeks (50% dose reduction).

PROCEDURE

Venapuncture

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

OTHER

Dermatology Life Quality Index (DLQI)

The impact of the disease on the patient will be assessed using the dermatology life quality index (DLQI).

OTHER

EQ-5D-5L questionnaire

The EQ-5D-5L which is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments will be assessed.

PROCEDURE

Dried blood spot sampling

A subset of patients will sample additionally by using dried blood sampling after the first drug injection post-inclusion.

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Jo Lambert, Prof. Dr. · University Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2022-03-22
Completion
2022-08-22

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683054 on ClinicalTrials.gov