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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)

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ClinicalTrials.gov Identifier: NCT03539419
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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
Psoriasis

Study Type : Observational
Estimated Enrollment : 150 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 TREATMENTS IN CONDITIONS OF CLINICAL PRACTICE IN SPAIN (APPROPRIATE Study)
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : July 25, 2019
Estimated Study Completion Date : July 25, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Apremilast

Group/Cohort
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.



Primary Outcome Measures :
  1. Percentage of subjects achieving PBI ≥ 1 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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). [ Time Frame: 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). [ Time Frame: 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 [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539419


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Spain
Hospital Juan Ramón Jiménez Not yet recruiting
Huelva, Andalucia, Spain, 50009
Complejo Hospitalario de Jaén Not yet recruiting
Jaen, Andalucía, Spain, 23007
Hospital Carlos Haya Not yet recruiting
Malaga, Andalucía, Spain, 29010
Hospital Universitario Marqués de Valdecilla Not yet recruiting
Santander, Cantabria, Spain, 39008
Hospital Nuestra Señora de Sonsoles Not yet recruiting
Avila, Castilla-León, Spain, 05004
Hospital Universitario Río hortega de Valladolid Not yet recruiting
Valladolid, Castilla-León, Spain, 47012
Hospital del Mar Not yet recruiting
Barcelona, Cataluña, Spain, 08003
Hospital Sant Pau Not yet recruiting
Barcelona, Cataluña, Spain, 08026
Hospital Valle Hebrón Not yet recruiting
Barcelona, Cataluña, Spain, 08035
Hospital de Bellvitge Not yet recruiting
Barcelona, Cataluña, Spain, 08907
Hospital General de Alicante Not yet recruiting
Alicante, Comunidad Valenciana, Spain, 03010
Hospital Clínico Valencia Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46010
Hospital General Valencia Not yet recruiting
Valencia, Comunidad Valenciana, Spain, 46014
Hospital La Fe Valencia Recruiting
Valencia, Comunidad Valenciana, Spain, 46026
Hospital Infanta Cristina Badajoz Not yet recruiting
Badajoz, Extremadura, Spain, 06080
Hospital Universitario de Pontevedra Not yet recruiting
Pontevedra, Galicia, Spain, 36164
Hospital Dr Negrin Not yet recruiting
Las Palmas de Gran Canaria, Islas Canarias, Spain, 35010
Hospital Universitario de Canarias Not yet recruiting
Santa Cruz de Tenerife, Islas Canarias, Spain, 38320
Hospital Santa Lucía Not yet recruiting
Cartagena, Murcia, Spain, 30202
Hospital La Princesa Not yet recruiting
Madrid, Spain, 28006
Hospital Infanta Leonor Not yet recruiting
Madrid, Spain, 28031
Hospital Universitario Puerta del Hierro Not yet recruiting
Madrid, Spain, 28222
Hospital de Móstoles Not yet recruiting
Madrid, Spain, 28933
Hospital Clínico de Zaragoza Not yet recruiting
Zaragoza, Áragon, Spain, 50009
Hospital Miguel Servet Not yet recruiting
Zaragoza, Áragon, Spain, 50009
Sponsors and Collaborators
Celgene
Investigators
Study Director: Carmen García, Senior Advocacy RML Celgene Corporation

Additional Information:
Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03539419     History of Changes
Other Study ID Numbers: CC-10004-PSOR-017
U1111-1212-0643 ( Registry Identifier: WHO )
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: November 21, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:
Psoriasis
Plaque Psoriasis
Apremilast
CC-10004

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Apremilast
Thalidomide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents