Clinical trial NCT03539419: Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain
Official title: Prospective Observational Study to Evaluate the Benefits for the Patient Associated With the Treatment of Plaque Psoriasis With Apremilast After Other Systemic Treatment in Conditions of Clinical Practice in Spain (APPROPRIATE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Plaque Psoriasis
Apremilast
CC-10004
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.

Brief summary: Observational, prospective and multicenter study in approximately 30 sites nationwide. The investigators participating in this study will be dermatologists specializing in this pathology.

The present study will include adult patients with moderate to severe plaque who have started apremilast treatment for first time 3 months (+/- 4 weeks) before their inclusion in the study, according to the specifications of the drug's prescribing information and under usual clinical practice. Recruitment will be consecutive and the reason for not including a potential candidate patient will be registered. The decision to prescribe apremilast treatment should be clearly dissociated from the inclusion of the patient in the study. Therefore, the choice of the therapeutic strategy will be made independently by the physician.


Eligibility criteria: Inclusion Criteria:

* Adult male and female (≥ 18 years).
* Patients diagnosed with moderate to severe plaque psoriasis and for which treatment with apremilast is indicated according to the doctor's criteria (established before the patient enters the study) and according to the specifications of the medication's data sheet
* Patients with available data regarding the PASI and DLQI assessments at the moment of initiating treatment with apremilast.
* Patients for whom, according to the physician's criteria (established prior to patient's entry into the study) and according to the specifications of the drug's prescribing information, apremilast treatment is indicated.
* All patients who, according to the routine clinical practice, initiated apremilast treatment for the first time 3 months (+/- 4 weeks) before their inclusion in the study (patients may or may not have completed 3 months of apremilast treatment).
* Patients who have previously received at least one systemic treatment for moderate to severe plaque psoriasis.
* Patients who have not previously been treated with a biological agent for moderate to severe plaque psoriasis.
* Patients who agree to participate in the study by signing the informed consent.
* Patients who are able to understand and complete the questionnaires specified in the study protocol.

Exclusion Criteria:

• Patients participating in another study at the time of entering the study.

Primary outcomes:
measure: Percentage of subjects achieving PBI ≥ 1
timeFrame: Approximately 7 months
Secondary outcomes:
measure: Describe the persistence of apremilast treatment
timeFrame: Approximately 7 months
measure: Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis
timeFrame: Approximately 13 months
measure: Describe the changes in the quality of life associated with treatment with apremilast
timeFrame: Approximately 13 months
measure: Describe the percentage of patients with moderate to severe plaque psoriasis who achieve a relevant minimum clinical benefit, defined as PBI ≥ 1
timeFrame: Approximately 13 months
measure: Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment
timeFrame: Approximately 13 months
measure: Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity
timeFrame: Approximately 13 months
measure: Adverse Events (AEs)
timeFrame: Approximately 13 months
measure: Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA).
timeFrame: Approximately 7 months
measure: Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA).
timeFrame: Approximately 7 months
measure: Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA
timeFrame: Approximately 7 months
Other outcomes:
Locations:
city: Huelva
country: Spain
facility: Hospital Juan Ramón Jiménez
state: Andalucia
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaén
state: Andalucía
city: Malaga
country: Spain
facility: Hospital Carlos Haya
state: Andalucía
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Royo Vilanova
state: Aragón
city: Las Palmas de Gran Canaria
country: Spain
facility: Research Site
state: Canarias
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Santander
country: Spain
facility: Research Site
state: Cantabria
city: Valladolid
country: Spain
facility: Research Site
state: Castilla León
city: Avila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
state: Castilla-León
city: Valladolid
country: Spain
facility: Hospital Universitario Río hortega de Valladolid
state: Castilla-León
city: Badalona
country: Spain
facility: Hospital Germans Tries i Pujol
state: Cataluña
city: Badalona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital del Mar
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Research Site
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Sant Pau
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital Valle Hebrón
state: Cataluña
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
state: Cataluña
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
state: Cataluña
city: Alicante
country: Spain
facility: Hospital General de Alicante
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital Clínico Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital General Valencia
state: Comunidad Valenciana
city: Valencia
country: Spain
facility: Hospital La Fe Valencia
state: Comunidad Valenciana
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina Badajoz
state: Extremadura
city: Ourense
country: Spain
facility: Hospital Universitario de Ourense
state: Galicia
city: Pontevedra
country: Spain
facility: Hospital Universitario de Pontevedra
state: Galicia
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Dr Negrin
state: Islas Canarias
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
state: Islas Canarias
city: Móstoles
country: Spain
facility: Research Site
state: Madrid
city: Cartagena, Murcia
country: Spain
facility: Hospital Santa Lucía
state: Murcia
city: Alicante
country: Spain
facility: Research Site
city: Badajoz
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cuesta
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Jaén
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Hospital de 12 Octubre
city: Madrid
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Hospital Universitario Puerta del Hierro
city: Madrid
country: Spain
facility: Hospital de Móstoles
city: Majadahonda
country: Spain
facility: Research Site
city: Murica
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Ourense
country: Spain
facility: Research Site
city: Pontevedra
country: Spain
facility: Research Site
city: Terrassa
country: Spain
facility: Research Site
city: València
country: Spain
facility: Research Site
city: València
country: Spain
facility: Research Site
city: València
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Ávila
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Hospital Clínico de Zaragoza
state: Áragon
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Áragon
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: