NCT04028713

Dose Tapering Study of Adalimumab in Psoriasis

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University Hospital, Ghent · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-02-16
• Primary completion: 2022-03-22
• Completion: 2022-03-22
• First posted: 2019-07-23
• Last updated: 2024-09-19

Locations

7 sites across 1 country: Belgium