A Phase 4 interventional study of Venapuncture and Dried blood spot in Psoriasis Vulgaris, sponsored by University Hospital, Ghent. Terminated at 7 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment
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.
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.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 19 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Patients will continue to receive adalimumab according to the standard dosing schedule.
Procedure: Venapuncture · Procedure: Dried blood spot
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
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab.
A subset of patients will sample additionally by using the dried blood sampling technique.
Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
Clinical response
The proportion of patients in each group in clinical remission (absolute PASI \< 2) at year 1 after optimization
Time frame: Week 0- Week 48
The proportion of patients in each group with serum trough levels of adalimumab within the optimal interval.
Time frame: Week 0- Week 48
The proportion of patients in each group with anti-drug antibodies (ADA) against adalimumab.
Time frame: Week 0- Week 48
Relapse
The proportion of patients in each group who relapses (defined as the need for dose escalation (not in the standard based dosing arm))
Time frame: Week 0- Week 48
Plan to share: No
This study is terminated, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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University Hospital, Ghent