Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Proactive therapeutic drug monitoring versus routine care with the novel biologics in psoriasis : a pragmatic, multicentric, randomised, controlled study |
| Participants (P) | Patients with moderate-to-severe psoriasis, treated with secukinumab or ixekizumab (IL-17 inhibitors) or guselkumab (IL-23 inhibitor) in daily clinical practice for at least 6 months on standard dosing (maintenance phase). |
| Intervention (I) | Stepwise treatment modifications based on drug levels: if the drug level is below/above the target, the dose of the biologic will be increased/decreased by stepwise interval shortening/lengthening – first modified by 33% and then 50% increase or decrease. If the target is still not reached at the next study visit, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached. In case the dosing regimen shifts from dose increase to dose decrease or vice versa, the dosing interval will be shortened or prolonged with one additional week at each additional visit until the target is reached. |
| Control (C) | Patients will receive biological therapy according to standard clinical practice. secukinumab, ixekizumab and guselkumab will be administered according to standard dosing regimen. Adjustments in doses and intervals, or biological switch according to clinical parameters or at the physicians’ discretion are considered as standard clinical practice. Investigators will not have access to information on levels of the drug or antidrug antibodies and no decision tree will be provided to guide treatment adjustments. |
| Outcome (O) | Primary outcome: sustained disease control is defined as an absolute PASI ≤ 2 OR a delta PASI (from baseline) ≥ 50% during at least 80% of all 3-monthly study visits over a period of 18 months. Key secondary outcomes: - Disease activity: change from baseline at 18 months in PASI score - Quality of life: change from baseline at 18 months in DLQI-R and SF36 scores - Cost-effectiveness, measured using the EQ5D5L and iMCQ |
| Trial Design | A multicentre, pragmatic, randomised, controlled, non-inferiority trial |
| Sample Size | 210 |
| Trial duration | 48 months |
| Budget | 2 210 000€ |
Trial team
| Sponsor | UZ Gent |
| Chief Investigator | Prof Dr Jo Lambert |
| External partners | None |
| Number of participating sites | 14 |
