Study Complete
Sponsor ID
CC-10004-PSOR-013

A Study of Real-World Experience of Psoriasis Patients Treated with Apremilast in Clinical Dermatology PracticeAPPRECIATE

Sponsor ID
CC-10004-PSOR-013
Clinicaltrials.gov ID
NCT02740218
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This is a retrospective, multi-center observational cohort study. This study will be implemented first in Germany (approximately 50 sites), the United Kingdom (approximately 20 sites) and Sweden (approximately 25 sites), followed by a selected number of countries in Europe, depending on apremilast local availability. The design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. In addition, this study is aiming at capturing physicians’ and patients’ treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. This study is primarily descriptive in nature, and no a priori hypotheses are specified. Patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. They must not be involved in any other clinical study involving apremilast.

Additional Study Details

Phase
N/A
Product
N/A
Type
Observational
Masking
N/A
Enrollment
610
Additional Study Details

Protocol Summary

Primary Outcome Measures

The Patient Benefit Index (PBI) outcome score

Timeframe: Up to approximately 7 months

Secondary Outcome Measures

Treatment Satisfaction Questionnaire for Medication (TSQM) outcome score

Timeframe: Up to approximately 7 months

Percentage of patients achieving PASI75

Timeframe: Up to approximately 7 months

Percentages of patients achieving PASI50

Timeframe: Up to approximately 7 months

Mean change in Dermatology Life Quality Index (DLQI)

Timeframe: Up to approximately 7 months

Percentages of patients achieving ≥5 point improvement in DLQI

Timeframe: Up to approximately 7 months

Percentages of patients achieving PASI50 plus ≥5 point improvement in DLQI

Timeframe: Up to approximately 7 months

Mean change in Body Surface Area (BSA)

Timeframe: Up to approximately 7 months

Mean change in PGA

Timeframe: Up to approximately 7 months

Percentage of patients achieving PGA 0/1 (clear/almost clear)

Timeframe: Up to approximately 7 months

Adverse Events (AEs)

Timeframe: Up to approximately 7 months

Locations

Location
Status
Contact Us
Location
Praxis Dr. Scheibner
Dresden, Germany, 01217
Status
Completed
Location
Praxis Dr. Kämmerer
Freiberg, Germany, 09599
Status
Completed
Location
Praxis Dr. Buttgereit
Wildau, Germany, 15745
Status
Terminated
Location
Praxis Birgit Zimmermann
Malchow, Germany, 17231
Status
Completed
Location
Praxis Dr. Blank
Rostock, Germany, 18055
Status
Terminated
Location
Praxis Dr. Hoene
Rostock, Germany, 18059
Status
Terminated
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