A Non-interventional Prospective Cohort Study to Provide Real-world Evidence on the Treatment Goal Achievement Rate, Adherence to and Utilization Patterns of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in Greece

AbbVie43 sites in 1 country273 target enrollmentJune 16, 2016

ConditionsModerate to Severe Plaque Psoriasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Moderate to Severe Plaque Psoriasis
Sponsor: AbbVie
Enrollment: 273
Locations: 43
Primary Endpoint: Proportion of participants who will achieve the European Consensus Programme (ECP)-defined treatment goals at the end of the induction phase (i.e. 16 weeks post-treatment onset)
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study estimates the treatment goal achievement rate, depicts the implementation of the Progressive Psoriasis Initiative (PPI) recommendations regarding treatment modifications and transitioning, and assesses patient adherence and persistence with adalimumab therapy in the routine clinical practice in Greece.

Registry

clinicaltrials.gov

Start Date

June 16, 2016

End Date

April 19, 2019

Last Updated

6 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of plaque psoriasis for at least 6 months, and moderate to severe disease course at the time of adalimumab treatment onset, defined as Body Surface Area (BSA) \>10 or PASI \>10 and DLQI \>10
•Patients for whom the decision to prescribe therapy with adalimumab (Humira®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study and is clearly separated from the physician's decision to include the patient in the current study
•Patients with an available Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) scores at the start of adalimumab treatment
•Patients able and willing to provide written informed consent and to comply with the requirements of this study protocol
•Patients with a signed informed consent document

Exclusion Criteria

•Patients should not have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular)
•Patients for whom treatment with adalimumab has been initiated more than 2 weeks prior to their enrolment into the study
•Patients that meet any of the contraindications to the administration of the study drug according to the latest version of the locally approved SmPC
•Patients who have previously been exposed to adalimumab unless a period of at least 6 months from the last dose has elapsed
•Patients currently receiving treatment with any investigational drug/device/intervention or who have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with adalimumab.

Outcomes

Primary Outcomes

Proportion of participants who will achieve the European Consensus Programme (ECP)-defined treatment goals at the end of the induction phase (i.e. 16 weeks post-treatment onset)

Time Frame: 16 weeks post-treatment

Achievement of the treatment goals during the induction phase is defined as: * Treatment Success: i.e. \>=75% Psoriasis Area Severity Index (PASI) score reduction OR * Intermediate Response with Dermatology Life Quality Index (DLQI) \<=5: i.e. PASI score reduction \>=50% but \<75% with DLQI \<=5.

Secondary Outcomes

Proportion of participant achieving treatment success(Up to 12 months)
Time to the first missed dose during the study observation period(Up to 12 months)
Proportion of participants achieving intermediate response(Up to 12 months)
Proportion of participant with treatment failure(Up to 12 months)
Proportion of participants achieving the treatment goals(Up to 12 months)