Clincosm LogoSign in Get a demo

APPROPIATE: 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

Sponsor
Amgen (Industry)
Overall Status
Completed
CT.gov ID
NCT03539419
Collaborator
(none)
153
Enrollment
58
Locations
28.6
Actual Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    153 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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)
    Actual Study Start Date :
    Jun 12, 2018
    Actual Primary Completion Date :
    Nov 2, 2019
    Actual Study Completion Date :
    Oct 31, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of subjects achieving PBI ≥ 1 [Approximately 7 months]

      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

    Secondary Outcome Measures

    1. Describe the persistence of apremilast treatment [Approximately 7 months]

      Is defined as the duration of time from initiation to discontinuation of therapy.

    2. Describe changes in the perception of pruritus intensity during apremilast treatment in patients with moderate to severe plaque psoriasis [Approximately 13 months]

      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

    3. Describe the changes in the quality of life associated with treatment with apremilast [Approximately 13 months]

      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).

    4. 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]

      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.

    5. Describe changes in concomitant medication associated with management of moderate to severe plaque psoriasis during apremilast treatment [Approximately 13 months]

      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.

    6. Describe changes in cutaneous involvement of patients with psoriasis in severe intensity plaques that change to moderate intensity [Approximately 13 months]

      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.

    7. Adverse Events (AEs) [Approximately 13 months]

      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.

    8. Clinical and demographic characteristics of plaque psoriasis patients: Body surface affected (BSA). [Approximately 7 months]

      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).

    9. Clinical and demographic characteristics of plaque psoriasis patients: Physician Global Assessment (PGA). [Approximately 7 months]

      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".

    10. Clinical and demographic characteristics of plaque psoriasis patients: PGA x BSA [Approximately 7 months]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Juan Ramón Jiménez Huelva Andalucia Spain 50009
    2 Complejo Hospitalario de Jaén Jaen Andalucía Spain 23007
    3 Hospital Carlos Haya Malaga Andalucía Spain 29010
    4 Research Site Zaragoza Aragón Spain 50014
    5 Hospital Royo Vilanova Zaragoza Aragón Spain 50015
    6 Research Site Las Palmas de Gran Canaria Canarias Spain 35010
    7 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
    8 Research Site Santander Cantabria Spain 39008
    9 Research Site Valladolid Castilla León Spain 47012
    10 Hospital Nuestra Señora de Sonsoles Avila Castilla-León Spain 05004
    11 Hospital Universitario Río hortega de Valladolid Valladolid Castilla-León Spain 47012
    12 Hospital Germans Tries i Pujol Badalona Cataluña Spain 08026
    13 Research Site Badalona Cataluña Spain 08916
    14 Hospital del Mar Barcelona Cataluña Spain 08003
    15 Research Site Barcelona Cataluña Spain 08003
    16 Research Site Barcelona Cataluña Spain 08025
    17 Hospital Sant Pau Barcelona Cataluña Spain 08026
    18 Hospital Valle Hebrón Barcelona Cataluña Spain 08035
    19 Hospital de Bellvitge Barcelona Cataluña Spain 08907
    20 Hospital Mutua de Terrassa Terrassa Cataluña Spain 08221
    21 Hospital General de Alicante Alicante Comunidad Valenciana Spain 03010
    22 Hospital Clínico Valencia Valencia Comunidad Valenciana Spain 46010
    23 Hospital General Valencia Valencia Comunidad Valenciana Spain 46014
    24 Hospital La Fe Valencia Valencia Comunidad Valenciana Spain 46026
    25 Hospital Infanta Cristina Badajoz Badajoz Extremadura Spain 06080
    26 Hospital Universitario de Ourense Ourense Galicia Spain 32005
    27 Hospital Universitario de Pontevedra Pontevedra Galicia Spain 36164
    28 Hospital Dr Negrin Las Palmas de Gran Canaria Islas Canarias Spain 35010
    29 Hospital Universitario de Canarias Santa Cruz de Tenerife Islas Canarias Spain 38320
    30 Hospital Santa Lucía Cartagena, Murcia Murcia Spain 30202
    31 Research Site Alicante Spain 03010
    32 Research Site Badajoz Spain 06010
    33 Research Site Barcelona Spain 08907
    34 Research Site Cuesta Spain 38320
    35 Research Site Huelva Spain 21003
    36 Research Site Jaén Spain 23007
    37 Hospital La Princesa Madrid Spain 28006
    38 Research Site Madrid Spain 28006
    39 Hospital Infanta Leonor Madrid Spain 28031
    40 Research Site Madrid Spain 28031
    41 Hospital de 12 Octubre Madrid Spain 28041
    42 Research Site Madrid Spain 28041
    43 Hospital Universitario Puerta del Hierro Madrid Spain 28222
    44 Hospital de Móstoles Madrid Spain 28933
    45 Research Site Madrid Spain 28935
    46 Research Site Majadahonda Spain 28022
    47 Research Site Murcia Spain 30203
    48 Research Site Málaga Spain 29009
    49 Research Site Ourense Spain 32003
    50 Research Site Pontevedra Spain 36001
    51 Research Site Terrassa Spain 08221
    52 Research Site València Spain 46010
    53 Research Site València Spain 46014
    54 Research Site València Spain 46026
    55 Research Site Zaragoza Spain 50009
    56 Research Site Ávila Spain 05004
    57 Hospital Clínico de Zaragoza Zaragoza Áragon Spain 50009
    58 Hospital Miguel Servet Zaragoza Áragon Spain 50009

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT03539419
    Other Study ID Numbers:
    • CC-10004-PSOR-017
    • U1111-1212-0643
    First Posted:
    May 29, 2018
    Last Update Posted:
    Dec 21, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    Psoriasis
    Plaque Psoriasis
    Apremilast
    CC-10004
    Additional relevant MeSH terms:
    Psoriasis

    Study Results

    No Results Posted as of Dec 21, 2020