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
APPROPIATE
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)
2 other identifiers
observational
153
1 country
58
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2018
Typical duration for all trials
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
June 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedJune 5, 2024
June 1, 2024
1.4 years
April 20, 2018
June 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Describe the persistence of apremilast treatment
Approximately 7 months
Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis
Approximately 13 months
Describe the changes in the quality of life associated with treatment with apremilast
Approximately 13 months
Describe the percentage of patients with moderate to severe plaque psoriasis who achieve a relevant minimum clinical benefit, defined as PBI ≥ 1
Approximately 13 months
Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment
Approximately 13 months
- +5 more secondary outcomes
Study Arms (1)
Patients with plaque psoriasis on apremilast
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
- 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.
You may not qualify if:
- Patients participating in another study at the time of entering the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (58)
Hospital Juan Ramón Jiménez
Huelva, Andalusia, 50009, Spain
Complejo Hospitalario de Jaén
Jaén, Andalusia, 23007, Spain
Hospital Carlos Haya
Málaga, Andalusia, 29010, Spain
Research Site
Zaragoza, Aragon, 50014, Spain
Hospital Royo Vilanova
Zaragoza, Aragon, 50015, Spain
Hospital Dr Negrin
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Research Site
Las Palmas de Gran Canaria, Canary Islands, 35010, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Canary Islands, 38320, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Research Site
Santander, Cantabria, 39008, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, Castille and León, 05004, Spain
Hospital Universitario Río hortega de Valladolid
Valladolid, Castille and León, 47012, Spain
Research Site
Valladolid, Castille and León, 47012, Spain
Hospital Germans Tries i Pujol
Badalona, Catalonia, 08026, Spain
Research Site
Badalona, Catalonia, 08916, Spain
Hospital del Mar
Barcelona, Catalonia, 08003, Spain
Research Site
Barcelona, Catalonia, 08003, Spain
Research Site
Barcelona, Catalonia, 08025, Spain
Hospital Sant Pau
Barcelona, Catalonia, 08026, Spain
Hospital Valle Hebrón
Barcelona, Catalonia, 08035, Spain
Hospital de Bellvitge
Barcelona, Catalonia, 08907, Spain
Hospital Mutua de Terrassa
Terrassa, Catalonia, 08221, Spain
Hospital Infanta Cristina Badajoz
Badajoz, Extremadura, 06080, Spain
Hospital Universitario de Ourense
Ourense, Galicia, 32005, Spain
Hospital Universitario de Pontevedra
Pontevedra, Galicia, 36164, Spain
Research Site
Móstoles, Madrid, 28935, Spain
Hospital Santa Lucía
Cartagena, Murcia, Murcia, 30202, Spain
Hospital General de Alicante
Alicante, Valencia, 03010, Spain
Hospital Clínico Valencia
Valencia, Valencia, 46010, Spain
Hospital General Valencia
Valencia, Valencia, 46014, Spain
Hospital La Fe Valencia
Valencia, Valencia, 46026, Spain
Research Site
Alicante, 03010, Spain
Research Site
Ávila, 05004, Spain
Research Site
Badajoz, 06010, Spain
Research Site
Barcelona, 08907, Spain
Research Site
Cuesta, 38320, Spain
Research Site
Huelva, 21003, Spain
Research Site
Jaén, 23007, Spain
Hospital La Princesa
Madrid, 28006, Spain
Research Site
Madrid, 28006, Spain
Hospital Infanta Leonor
Madrid, 28031, Spain
Research Site
Madrid, 28031, Spain
Hospital de 12 Octubre
Madrid, 28041, Spain
Research Site
Madrid, 28041, Spain
Hospital Universitario Puerta del Hierro
Madrid, 28222, Spain
Hospital de Móstoles
Madrid, 28933, Spain
Research Site
Majadahonda, 28022, Spain
Research Site
Málaga, 29009, Spain
Research Site
Murica, 30203, Spain
Research Site
Ourense, 32003, Spain
Research Site
Pontevedra, 36001, Spain
Research Site
Terrassa, 08221, Spain
Research Site
Valencia, 46010, Spain
Research Site
Valencia, 46014, Spain
Research Site
Valencia, 46026, Spain
Research Site
Zaragoza, 50009, Spain
Hospital Clínico de Zaragoza
Zaragoza, Áragon, 50009, Spain
Hospital Miguel Servet
Zaragoza, Áragon, 50009, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2018
First Posted
May 29, 2018
Study Start
June 12, 2018
Primary Completion
November 2, 2019
Study Completion
October 31, 2020
Last Updated
June 5, 2024
Record last verified: 2024-06