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

Psoriasis Clinical Trial

— APPROPIATE  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03539419
• Other study ID #: CC-10004-PSOR-017
• Secondary ID: U1111-1212-0643
• Status: Completed
• Start date: June 12, 2018
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2024
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: October 31, 2020
• Est. primary completion date: November 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Locations

Country	Name	City	State
Spain	Hospital General de Alicante	Alicante	Comunidad Valenciana
Spain	Research Site	Alicante
Spain	Hospital Nuestra Señora de Sonsoles	Avila	Castilla-León
Spain	Research Site	Ávila
Spain	Hospital Infanta Cristina Badajoz	Badajoz	Extremadura
Spain	Research Site	Badajoz
Spain	Hospital Germans Tries i Pujol	Badalona	Cataluña
Spain	Research Site	Badalona	Cataluña
Spain	Hospital de Bellvitge	Barcelona	Cataluña
Spain	Hospital del Mar	Barcelona	Cataluña
Spain	Hospital Sant Pau	Barcelona	Cataluña
Spain	Hospital Valle Hebrón	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona
Spain	Hospital Santa Lucía	Cartagena, Murcia	Murcia
Spain	Research Site	Cuesta
Spain	Hospital Juan Ramón Jiménez	Huelva	Andalucia
Spain	Research Site	Huelva
Spain	Complejo Hospitalario de Jaén	Jaen	Andalucía
Spain	Research Site	Jaén
Spain	Hospital Dr Negrin	Las Palmas de Gran Canaria	Islas Canarias
Spain	Research Site	Las Palmas de Gran Canaria	Canarias
Spain	Hospital de 12 Octubre	Madrid
Spain	Hospital de Móstoles	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Universitario Puerta del Hierro	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Majadahonda
Spain	Hospital Carlos Haya	Malaga	Andalucía
Spain	Research Site	Málaga
Spain	Research Site	Móstoles	Madrid
Spain	Research Site	Murica
Spain	Hospital Universitario de Ourense	Ourense	Galicia
Spain	Research Site	Ourense
Spain	Hospital Universitario de Pontevedra	Pontevedra	Galicia
Spain	Research Site	Pontevedra
Spain	Hospital Universitario de Canarias	Santa Cruz de Tenerife	Islas Canarias
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Research Site	Santander	Cantabria
Spain	Hospital Mutua de Terrassa	Terrassa	Cataluña
Spain	Research Site	Terrassa
Spain	Hospital Clínico Valencia	Valencia	Comunidad Valenciana
Spain	Hospital General Valencia	Valencia	Comunidad Valenciana
Spain	Hospital La Fe Valencia	Valencia	Comunidad Valenciana
Spain	Research Site	València
Spain	Research Site	València
Spain	Research Site	València
Spain	Hospital Universitario Río hortega de Valladolid	Valladolid	Castilla-León
Spain	Research Site	Valladolid	Castilla León
Spain	Hospital Clínico de Zaragoza	Zaragoza	Áragon
Spain	Hospital Miguel Servet	Zaragoza	Áragon
Spain	Hospital Royo Vilanova	Zaragoza	Aragón
Spain	Research Site	Zaragoza
Spain	Research Site	Zaragoza	Aragón

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects achieving PBI = 1	Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment	Approximately 7 months
Secondary	Describe the persistence of apremilast treatment	Is defined as the duration of time from initiation to discontinuation of therapy.	Approximately 7 months
Secondary	Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis	Pruritus intensity measures: Usually used scales are based on patient perception: Visual analogue scale (VAS). Horizontal line of 100 mm, with descriptive signs at the ends indicating "no itching" and "the worst imaginable itch". The score is obtained by measuring the distance in millimeters from the beginning of the line to a vertical mark placed by the patient to indicate the intensity of the pain	Approximately 13 months
Secondary	Describe the changes in the quality of life associated with treatment with apremilast	The information on the variables studied will be obtained from the clinical record and the tests and evaluations carried out routinely during the patient follow-up who initiate a first treatment with apremilast, as well as the questionnaires for the evaluation of the dermatological quality of life (DLQI self-administered questionnaire), the evaluation of treatment satisfaction reported by the patient (PBI) and the intensity of pruritus (self-reported measures, VAS).	Approximately 13 months
Secondary	Describe the percentage of patients with moderate to severe plaque psoriasis who achieve a relevant minimum clinical benefit, defined as PBI = 1	Patient Benefit Index (PBI) is a measure of the benefit associated with a patient-reported treatment consisting of the administration of two questionnaires: the Patient needs questionnaire (PNQ), administered at baseline, and the patient benefit questionnaire (PBQ), administered during treatment.	Approximately 13 months
Secondary	Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment	Describe changes of concomitant medication specific for psoriasis associated to apremilast treatment indicating the date of beginning and end of the concomitant treatments that the patient receives during the treatment with apremilast.	Approximately 13 months
Secondary	Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity	A patient with moderate-intensity psoriasis will be considered if he/she has PASI 7-15 and DLQI scores = 15, or PASI scores <7 and DLQI = 5 at the time of starting apremilast treatment. (Patients with PASI 7-15 and DLQI> 15 scores and presenting cutaneous lesions in locations that are difficult to access for treatment or that have a significant psychosocial impact may be classified as moderate or severe psoriasis cases according to the investigators' criteria.) In this subgroup of patients will estimate the proportion of patients with moderate-intensity psoriasis who change to mild intensity.	Approximately 13 months
Secondary	Adverse Events (AEs)	Number of subjects with adverse event. Safety and tolerability to treatment will be assessed by the collection of adverse events (AE) occurring during follow-up.	Approximately 13 months
Secondary	Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA).	Psoriasis is characterized as mild, moderate, or severe according to the amount of body surface area (BSA) affected and the severity of redness, thickness, and scaling of the skin. According to the centers usual clinical practice, the clinical assessment of psoriatic disease is based on the BSA. Percentage of body surface affected by psoriasis (scale 0-100).	Approximately 7 months
Secondary	Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA).	The Psoriasis Global Assessment (PGA) of improvement (or Physician's global assessment of improvement) measure the global assessment of the patient's overall severity of the disease on a 6-point scale, scored from "severe" to "clear".	Approximately 7 months
Secondary	Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA	Commonly used instruments for measuring psoriasis, such as Psoriasis Area and Severity Index (PASI), have limitations, including high complexity. PGAxBSA is a simple and sensitive instrument for measuring psoriasis severity. PGA×BSA is practical alternative to PASI for measuring severity and treatment response	Approximately 7 months

External Links

•   AmgenTrials clinical trials website
•   Expanded Access for CC-10004