NCT03059953

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 encompasses treatment with biologic agents. The direct and indirect costs of biologic treatment, accruing, among others, from the high drug acquisition and administration costs, the required baseline safety screening and subsequent routine monitoring as well as the potential loss of patients' working hours constitute a significant financial burden on the public healthcare system. In light of the above evidence, it appears that in routine care apremilast may fulfill an important gap in the treatment armamentarium of psoriasis by providing a promising treatment option to be employed prior to biologics, which has demonstrated efficacy even in hard-to-treat areas such as the scalp, nails, palms and soles, and has a limited manageable safety profile, while being more convenient and cost-effective than biologics. In view of the scarcity of real-world evidence regarding the impact of apremilast on the patients' health-related quality of life (HRQoL) and extent and severity of the disease, and under the consideration that the moderate psoriasis patient {defined as \[10\<body surface area (BSA)\<20 or 10\<psoriasis area severity index (PASI)\<20\] and 10\<dermatology quality of life index (DLQI)\<20}, naïve to biologic treatment was likely underrepresented in the pivotal ESTEEM trials since approximately 30% of the enrolled patients had been previously treated with biologic therapy, 28-30% had a baseline PASI score \>20, and 48-52% had a BSA \>20%, this study represents an attempt to examine the impact of apremilast in routine clinical practice settings in Greece on the patient with moderate plaque psoriasis when this therapeutic strategy precedes biologics in the treatment algorithm. Specifically, the present study aims to generate novel real-world evidence on the effect of apremilast treatment in biologic treatment naïve patients with moderate plaque psoriasis in terms of the patients' HRQoL, patient-perceived benefits of therapy, treatment response rate, and impact on nail, scalp and palmoplantar psoriatic involvement and severity of pruritus, while concurrently assessing apremilast survival rate and cost per PASI-75 responder in the routine clinical practice of Greece.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 17, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 7, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2019

Completed
Last Updated

August 19, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

February 17, 2017

Last Update Submit

August 16, 2021

Conditions

Moderate Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Quality of Life - Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)

    Percentage of patients with moderate plaque psoriasis treated with apremilast who will achieve a DLQI total score ≤ 5 (i.e., no or small effect of their skin problem on HRQoL)

    at 24 weeks post-treatment onset

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male and female patients ≥ 18 years of age, 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 and naïve to biologic treatments

You may qualify if:

  • 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 be able to adhere to the study visit schedule and other protocol requirements.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

401 General Military Hospital

Athens, Greece

Location

Related Publications (1)

  • Ioannides D, Antonakopoulos N, Georgiou S, Chasapi V, Katsantonis I, Drosos A, Rigopoulos D, Antoniou C, Anastasiadis G, Bassukas I, Ioannidou D, Protopapa A, Neofotistou O, Krasagakis K, Aronis P, Papageorgiou M, Lazaridou E, Patsatsi A, Lefaki I, Roussaki-Schulze AV, Satra F, Anagnostopoulos Z, Papakonstantis M. Effectiveness and safety of apremilast in biologic-naive patients with moderate psoriasis treated in routine clinical practice in Greece: the APRAISAL study. J Eur Acad Dermatol Venereol. 2021 Sep;35(9):1838-1848. doi: 10.1111/jdv.17392. Epub 2021 Jul 13.

    PMID: 34036627RESULT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

February 23, 2017

Study Start

April 7, 2017

Primary Completion

April 6, 2018

Study Completion

April 24, 2019

Last Updated

August 19, 2021

Record last verified: 2021-05

Locations

GR(1)