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Too slow inclusion rate.
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| Name | Class |
|---|---|
| KU Leuven | OTHER |
| University Ghent | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard dosing group | Active Comparator | Patients will continue to receive adalimumab according to the standard dosing schedule. |
|
| Dose tapering group | Experimental | Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venapuncture | Procedure | Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | The proportion of patients in each group in clinical remission (absolute PASI < 2) at year 1 after optimization | Week 0- Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jo Lambert, Prof, dr | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Maria Middelares | Ghent | East-Flanders | 9000 | Belgium | ||
| AZ Sint-Lucas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35683398 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D059788 | Dried Blood Spot Testing |
| D000084862 | Drug Tapering |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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A randomized non-inferiority study
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| Dried blood spot | Procedure | A subset of patients will sample additionally by using the dried blood sampling technique. |
|
| Dose reduction | Drug | Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab. |
|
| 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 |
| Ghent |
| East-Flanders |
| 9000 |
| Belgium |
| University Hospital Ghent | Ghent | East-Flanders | 9000 | Belgium |
| Private practice Dermatology | Maldegem | East-Flanders | 9990 | Belgium |
| University Hospital Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
| AZ Delta Rembert | Torhout | West-Flanders | 8820 | Belgium |
| AZ Sint-Jan | Bruges | West-Vlaanderen | 8000 | Belgium |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |