Effectiveness and safety of biological drugs in psoriasis

Monitoring the effectiveness and safety of biological drugs for treatment of psoriasis through evaluation of clinical and biological markers - FARM1275JK

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-001695-26-IT

Enrollment

154

Registered

2020-11-04

Start date

2018-09-12

Completion date

Unknown

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe psoriasis and joint disease MedDRA version: 20.0 Level: PT Classification code 10037153 Term: Psoriasis System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859

Interventions

Product Name: Etanercept Product Code: [xxxx] Pharmaceutical Form: Solution for injection CAS Number: 185243-69-0 Current Sponsor code: xxxx Other descriptive name: Etanercept Concentration unit: 1X 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: both sexes, aged 18-75, affected by moderate to severe psoriasis eligible to systemic treatment with biologic drugs (etanercept, stelara), either as first line therapy or after three months of wash out will be enrolled in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 54

Exclusion criteria

Exclusion criteria: Breast feeding women Women planning a pregnancy History of cancer

Design outcomes

Primary

Measure	Time frame
Main Objective: • Primary objectives of the study will be to comparatively assess the effectiveness of anti-TNF-alfa (etanercept) and anti-p40 subunit of IL-12 and IL-23 (ustekinumab) on psoriasis patients with cutaneous and joint involvement. The choice of etanercept among anti-TNF drugs is motivated by the following reasons: i) minor risk of infections (Altomare G et al. 2008); ii) equivalent therapeutic effect as compared to other anti-TNF drugs (Gladman DD. 2008) (27,28,29); ììì) opportunity to assess the efficacy of a biosimilar drug and the feasibility of its use in place of the “originator” with consequent reduction of the financial burden for the public health system (Aladul Mi et al. 2017).;Secondary Objective: Secondary objectives of the study will be: 1) to assess the possible modifications of a series of soluble and cellular biomarkers involved in the pathogenesis of psoriatic disease after 12, 24 and 48 weeks of treatment; 2) evaluate the proportion of patients in the 2 treatment arms that maintains a state of MDA at weeks 24, 48, 72; 3) Safety assessment, through the registration of the number and type of emerging adverse events, with particular reference to those possibly or certainly related to the drugs administration.;Primary end point(s): Proportion of patients in the 2 treatment arms that reaches the status of "Minimal Disease Activity" (MDA) after 12 weeks of treatment. MDA represents a composite index consisting of 7 points comprising 7 variables (see: Coates LC et al. Ann Rheum Dis 2010; 69: 48-53). In detail, it is considered achieved the status of MDA (efficacy criterion) when 5 of the 7 following criteria are satisfied: N° of tender joints (range 0-68) = 1; of swollen joints (range 0-66) = 1; Body Surface Area (BSA; range 0-100) = 3; VAS articular pain (range 0-100) = 15; VAS global activity disease defined by the patient (range 0-100) = 20; "Health Assessment Questionnaire (HAQ; 0-3) = 0.3; enthesis pain on palpation (Leeds Enthesitis Inde	—

Measure

Time frame

Main Objective: • Primary objectives of the study will be to comparatively assess the effectiveness of anti-TNF-alfa (etanercept) and anti-p40 subunit of IL-12 and IL-23 (ustekinumab) on psoriasis patients with cutaneous and joint involvement. The choice of etanercept among anti-TNF drugs is motivated by the following reasons: i) minor risk of infections (Altomare G et al. 2008); ii) equivalent therapeutic effect as compared to other anti-TNF drugs (Gladman DD. 2008) (27,28,29); ììì) opportunity to assess the efficacy of a biosimilar drug and the feasibility of its use in place of the “originator” with consequent reduction of the financial burden for the public health system (Aladul Mi et al. 2017).;Secondary Objective: Secondary objectives of the study will be: 1) to assess the possible modifications of a series of soluble and cellular biomarkers involved in the pathogenesis of psoriatic disease after 12, 24 and 48 weeks of treatment; 2) evaluate the proportion of patients in the 2 treatment arms that maintains a state of MDA at weeks 24, 48, 72; 3) Safety assessment, through the registration of the number and type of emerging adverse events, with particular reference to those possibly or certainly related to the drugs administration.;Primary end point(s): Proportion of patients in the 2 treatment arms that reaches the status of "Minimal Disease Activity" (MDA) after 12 weeks of treatment. MDA represents a composite index consisting of 7 points comprising 7 variables (see: Coates LC et al. Ann Rheum Dis 2010; 69: 48-53). In detail, it is considered achieved the status of MDA (efficacy criterion) when 5 of the 7 following criteria are satisfied: N° of tender joints (range 0-68) = 1; of swollen joints (range 0-66) = 1; Body Surface Area (BSA; range 0-100) = 3; VAS articular pain (range 0-100) = 15; VAS global activity disease defined by the patient (range 0-100) = 20; "Health Assessment Questionnaire (HAQ; 0-3) = 0.3; enthesis pain on palpation (Leeds Enthesitis Inde

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Secondary

Measure	Time frame
Secondary end point(s): evaluate the proportion of patients in the 2 treatment arms that maintains a state of MDA at weeks 24, 48, 72; Safety assessment, through the registration of the number and type of emerging adverse events, with particular reference to those possibly or certainly related to the drugs administration.number and type of adverse events emerged in the course of the study. Since the biological drugs may have putative immunosuppressive effects, further specific endpoints of safety include: a) alterations of the response to "recall" antigens (i.e. CMV; EBV; Flu; Candida); b) the onset of severe infections (needing i.v. antibiotic therapy or hospitalisation).; o assess the possible modifications of a series of soluble and cellular biomarkers involved in the pathogenesis of psoriatic disease after 12, 24 and 48 weeks of treatment considering significant variations =20% of the values of biomarkers studied at weeks 12, 24 and 48;Timepoint(s) of evaluation of this end point: 24-48-72 weeks; within 36 months; 12, 24, 48 weeks	—

Measure

Time frame

Secondary end point(s): evaluate the proportion of patients in the 2 treatment arms that maintains a state of MDA at weeks 24, 48, 72; Safety assessment, through the registration of the number and type of emerging adverse events, with particular reference to those possibly or certainly related to the drugs administration.number and type of adverse events emerged in the course of the study. Since the biological drugs may have putative immunosuppressive effects, further specific endpoints of safety include: a) alterations of the response to "recall" antigens (i.e. CMV; EBV; Flu; Candida); b) the onset of severe infections (needing i.v. antibiotic therapy or hospitalisation).; o assess the possible modifications of a series of soluble and cellular biomarkers involved in the pathogenesis of psoriatic disease after 12, 24 and 48 weeks of treatment considering significant variations =20% of the values of biomarkers studied at weeks 12, 24 and 48;Timepoint(s) of evaluation of this end point: 24-48-72 weeks; within 36 months; 12, 24, 48 weeks

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Countries

Italy

Contacts

Public ContactClaudio Bonifati

Istituti Fisioterapici Ospitalieri

claudio.bonifati@ifo.gov.it52665140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026