Status:

COMPLETED

A Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study)

Lead Sponsor:

Genesis Pharma S.A.

Collaborating Sponsors:

Celgene

Conditions:

Moderate Plaque Psoriasis

Eligibility:

All Genders

18+ years

Brief Summary

For patients with moderate plaque psoriasis who are intolerable to, have a contraindication to or have failed classical systemic treatments, the current commonly employed management strategy encompass...

Eligibility Criteria

Inclusion Criteria:

Patients eligible for inclusion in this study have to meet all of the following criteria:

  • Male and female patients ≥ 18 years of age at the time of informed consent;
  • Patients diagnosed with moderate chronic plaque psoriasis [(10<BSA<20 or 10<PASI<20) and 10<DLQI<20], who failed to respond to or who have a contraindication to, or are intolerant to other classical systemic therapy;
  • Patients naïve to biologic treatments;
  • Patients for whom the decision to prescribe therapy with apremilast (Otezla®) according to the locally approved summary of product characteristics (SmPC) has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study;
  • Patients with available BSA, PASI and DLQI scores at the start of apremilast treatment;
  • Patients must be able to read, understand and complete the study specific questionnaires;
  • Patients must provide a written Informed Consent prior to inclusion to the study;
  • Patients must be able to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from participation in this study:

  • Patients who have initiated treatment with apremilast more than 7 days before enrollment into the study;
  • Patients that meet any of the contraindications to the administration of the apremilast as outlined in the latest version of the locally approved SmPC;
  • Patients currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with apremilast;
  • Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.

Key Trial Info

Start Date :

April 7 2017

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 24 2019

Estimated Enrollment :

302 Patients enrolled

Trial Details

Trial ID

NCT03059953

Start Date

April 7 2017

End Date

April 24 2019

Last Update

August 19 2021

Active Locations (1)

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Page 1 of 1 (1 locations)

1

401 General Military Hospital

Athens, Greece

A Study of Treatment With APRemilast in Moderate psoriAsIS in Real Life clinicAL Practice (The 'APRAISAL' Study) | DecenTrialz