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Study Complete
Sponsor ID
CC-10004-PSOR-017

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 SpainAPPROPIATE

Sponsor ID
CC-10004-PSOR-017
Clinicaltrials.gov ID
NCT03539419
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
153
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of subjects achieving PBI ≥ 1

Timeframe: Approximately 7 months

Secondary Outcome Measures

Describe the persistence of apremilast treatment

Timeframe: Approximately 7 months

Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis

Timeframe: Approximately 13 months

Describe the changes in the quality of life associated with treatment with apremilast

Timeframe: 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

Timeframe: Approximately 13 months

Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment

Timeframe: Approximately 13 months

Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity

Timeframe: Approximately 13 months

Adverse Events (AEs)

Timeframe: Approximately 13 months

Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA).

Timeframe: Approximately 7 months

Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA).

Timeframe: Approximately 7 months

Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA

Timeframe: Approximately 7 months

Locations

Location
Status
Contact Us
Location
Research Site
Ávila, Spain, 05004
Status
Recruiting
Location
Research Site
Alicante, Spain, 03010
Status
Recruiting
Location
Research Site
Badajoz, Spain, 06010
Status
Recruiting
Location
Research Site
Badalona, Cataluña, Spain, 08916
Status
Recruiting
Location
Research Site
Barcelona, Cataluña, Spain, 08003
Status
Recruiting
Location
Research Site
Barcelona, Cataluña, Spain, 08025
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Jun 2018 - Nov 2019
    Inclusion and Exclusion 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.