SECUKINUMAB for Moderate-to-severe psoriasis

Inclusion criteria

• {"criterion_text":"- 1.\tAdults; aged 18 years or older\n- 2.\tDocumented diagnosis of psoriasis (predominantly type vulgaris; based on clinical diagnosis) by an accredited dermatologist\n- 3.\tPatients must be currently treated with secukinumab, ixekizumab or guselkumab ≥ 6 months according to the standard dosing scheme.\n- 4.\tThe subject signs and dates a written informed consent form and any required privacy authorization prior to the initiation of any study procedures"}

Exclusion criteria

• {"criterion_text":"- 1.\tAnother indication than plaque psoriasis as the main indication for biologic use (e.g. receives biologic for rheumatoid arthritis as the main indication)\n- 2.\tConcomitant use of systemic immunosuppressants other than methotrexate or acitretin (e.g. prednisone, cyclosporine etc)\n- Severe comorbidities with short life-expectancy (e.g. metastasized tumour) or uncontrolled PsA at inclusion/baseline\n- Presumed inability to follow the study protocol\n- 5.\tActive pregnancy wish"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint is sustained disease control, 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.","definition_or_measurement_approach":"Sustained disease control defined as absolute PASI ≤ 2 OR delta PASI from baseline ≥ 50% during at least 80% of all 3-monthly study visits over 18 months; measured using PASI at 3-monthly visits over the 18-month period."}

Secondary endpoints

• {"endpoint_text":"- ●\tChange from baseline at 18 months in PASI score. The PASI measures disease activity. The scores ranges from 0 (skin lesion free) to 72 with higher scores indicating higher disease activity.","definition_or_measurement_approach":"Change from baseline in PASI at 18 months; PASI score range 0–72 with higher scores indicating greater disease activity."}
• {"endpoint_text":"- ●\tChange from baseline at 18 months in DLQI_R score. The DLQI_R measures QoL. The score ranges from 0 (no impact) to 30 (greatest impact) with higher scores indicating higher impact on quality of life.","definition_or_measurement_approach":"Change from baseline in DLQI_R at 18 months; DLQI_R score range 0–30 with higher scores indicating greater impact on quality of life."}
• {"endpoint_text":"- ●\tChange from baseline at 18 months in SF-36 score. The SF-36 measures QoL. The score ranges from 0 (maximum disability) to 100 (no disability). In the field of dermatology, the SF36 has been proposed as the instrument of choice for evaluating QoL in a generic way by Both et al.. Although we acknowledge that the SF36 can be perceived as more difficult to fill in by the patients, comparison of QoL measures by Fernandez-Penas et al, showed that SF‐36 was more sensitive than other instruments in d","definition_or_measurement_approach":"Change from baseline in SF-36 at 18 months; SF-36 scored 0–100 (higher = better health-related quality of life)."}
• {"endpoint_text":"- ●\tNew onset or flare of arthritis","definition_or_measurement_approach":"Occurrence of new onset or flare of arthritis during study follow-up as captured in clinical assessments."}
• {"endpoint_text":"- ●\tDrug discontinuation (incl. reasons)","definition_or_measurement_approach":"Record of drug discontinuation events and reasons during the 18-month study period."}
• {"endpoint_text":"- ●\tSerious adverse events (SAE)","definition_or_measurement_approach":"Collection and reporting of all serious adverse events per standard safety reporting procedures."}
• {"endpoint_text":"- ●\tAdverse events of special interest (AEoSI) ○\toccurrence of infusion reactions ○\tinfections","definition_or_measurement_approach":"Monitoring and recording of adverse events of special interest, specifically infusion reactions and infections."}
• {"endpoint_text":"- ●\tCost of treatment (medication used and cost of TDM)","definition_or_measurement_approach":"Assessment of medication use and therapeutic drug monitoring (TDM) costs for cost analyses."}
• {"endpoint_text":"- ●\tHealthcare consumption (iMCQ)","definition_or_measurement_approach":"Healthcare consumption measured using the iMCQ instrument."}
• {"endpoint_text":"- ●\tNumber of dose modifications during the 18 months (0 – 6)","definition_or_measurement_approach":"Count of dose modifications per participant during the 18-month follow-up (range 0–6)."}
• {"endpoint_text":"- ●\tChange from baseline at 18 months in TSQM score. The TSQM measures treatment satisfaction. TSQM is a 9-point questionnaire with scores ranging from 0 to 100. Higher scores indicate higher satisfaction.","definition_or_measurement_approach":"Change from baseline in TSQM at 18 months; TSQM scored 0–100 (higher = greater treatment satisfaction)."}
• {"endpoint_text":"- ●\tChange from baseline at 18 months in VAS score. The VAS measures treatment satisfaction. The VAS is a horizontal line of 100mm, with scores ranging from 0 (no satisfaction) to 10 (extreme satisfaction).","definition_or_measurement_approach":"Change from baseline in VAS at 18 months; VAS 0–10 (higher = greater satisfaction)."}
• {"endpoint_text":"- ●\tiMCQ and EQ-5D-5L to measure cost-effectiveness. Shikiar et al. showed that the EQ-5D index score is generally more highly correlated with clinical endpoints, compared with the SF-36, but displayed about the same degree of responsiveness. The MCID for the EQ-5D score is considered 6 units.","definition_or_measurement_approach":"Use of iMCQ and EQ-5D-5L instruments for cost-effectiveness analyses; EQ-5D index and iMCQ measures collected per instrument guidance."}

Belgium

Earliest CTIS Part Ii Submission Date

19-08-2024

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

557

Number Of Sites

14

Number Of Participants

210

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium