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Study Complete
Sponsor ID
CC-10004-PSOR-021

A study to assess benefits of apremilast in patients with moderate to severe chronic plaque psoriasis followed by dermatologists under real life settings in FranceREALIZE

Sponsor ID
CC-10004-PSOR-021
Clinicaltrials.gov ID
NCT03757013
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

REALIZE study will include a representative sample of 500 patients with moderate to severe plaque psoriasis for whom the treating dermatologist has decided to begin apremilast treatment in accordance with the local label reimbursement criteria. Patients may be enrolled into the study up to 4 weeks after starting the study treatment.

REALIZE is a longitudinal, multicenter, observational study under real life settings in patients with moderate to severe chronic plaque psoriasis after failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy).

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
453
Additional Study Details

Protocol Summary

Primary Outcome Measures

Proportion of patients with Patient Benefit Index score (PBI-S) ≥1 at 6 months after initiation of apremilast.

Timeframe: Up to 6 months

Secondary Outcome Measures

Proportion of subjects with PBI-S (range 0-4) at 6 months after apremilast initiation

Timeframe: Up to 6 months

Proportion of patients with PBI-S=4 at 6 months after apremilast initiation

Timeframe: Up to 6 months

Adherence Rate

Timeframe: Up to 12 months

Percentage of patients substituting apremilast

Timeframe: Up to 24 months

Dermatology Life Quality Index (DLQI)

Timeframe: Up to 24 months

Proportion of patients with DLQI ≤ 5

Timeframe: Up to 24 months

Proportion of patients achieving DLQI 0/1

Timeframe: Up to 24 months

Change in DLQI score from M0 to M6 and M12

Timeframe: Up to 12 months

Proportion of patients with improvement in DLQI ≥ 5 points between M0 and M6, M12

Timeframe: Up to 12 months

Treatment Satisfaction Questionnaire for Medication (TSQM9)

Timeframe: Up to 24 months

Proportion of patients with sPGA 0 or 1

Timeframe: Up to 24 months

Change in sPGA from baseline to M6 and M12

Timeframe: Up to 12 months

Percentage of BSA (%BSA) involved at M0, M6, M12

Timeframe: Up to 12 months

Change in % BSA from M0 to M6, M12

Timeframe: Up to 12 months

Psoriasis Area Severity Index (PASI) at M0, M6, M12

Timeframe: Up to 12 months

Change in PASI from M0 to M6, M12

Timeframe: Up to 12 months

Proportion of patients achieving PASI50 at M6, M12

Timeframe: Up to 12 months

Proportion of patients achieving PASI75 at M6, M12.

Timeframe: Up to 12 months

Adverse Events (AEs)

Timeframe: Up to 24 months

Duration of disease

Timeframe: Baseline

Number of areas of plaque psoriasis

Timeframe: Baseline

Type of chronic psoriasis involved

Timeframe: Baseline

The number of lines of previous systemic treatments

Timeframe: Baseline

Type of systemic therapy previously administered

Timeframe: Baseline

Duration of previous chronic psoriasis treatment

Timeframe: Baseline

Number of motivations of the prescription of apremilast

Timeframe: Up to 24 months

Percentage of motivations of the prescription of apremilast

Timeframe: Up to 24 months

Locations

Location
Status
Contact Us
Location
Private Practice, Paris
Paris, France, 75005
Status
Active, not recruiting
Location
Private Practice, Laval
Laval, France, 53000
Status
Active, not recruiting
Location
Private Practice, Dijon
Dijon, France, 21000
Status
Active, not recruiting
Location
Private Practice, Bordeaux
Bordeaux, France, 33000
Status
Active, not recruiting
Location
Private Practice, Toulouse
Toulouse, France, 31000
Status
Active, not recruiting
Location
Private Practice, Nevers
Nevers, France, 58000
Status
Terminated
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Study Info
Age
18+ years
Condition
  • Psoriasis
    • Sex
    All
    Trial Dates
    Sep 2018 - Jul 2021
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Male or female aged at least 18 years • Patient with a diagnosis of stable moderate to severe chronic plaque psoriasis • For whom the treating dermatologist has made the decision to initiate apremilast treatment in accordance with the local label and reimbursement criteria i.e. a history of failure or contra-indication or intolerance to other systemic therapy including ciclosporin, methotrexate, or phototherapy UVA + psoralen (PUVA therapy) • Patient having started apremilast up to 4 weeks before the enrolment visit for treatment of moderate to severe chronic plaque psoriasis even if apremilast has been stopped before inclusion in the study • Patient literate and willing to fill in questionnaires • Non-opposition form signed by the investigator indicating that the patient received information about the study, and orally agreed.
    Exclusion Criteria:
    • Patient who refuses to participate in the study or is unable to give his/her oral consent • Patient having participated in an interventional study in the last 30 days