A

• Conditions: moderate to severe chronic plaque-type psoriasis; MedDRA version: 18.0Level: PTClassification code 10037153Term: PsoriasisSystem Organ Class: 10040785 - Skin and subcutaneous tissue disorders; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2012-002011-26-HU
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-10
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 546

Inclusion Criteria

Patients must be able to understand and communicate with the investigator and comply with the requirements of the study [including administration of subcutaneous (s.c.) injections at home] and must give a written, signed and dated informed consent before any study related activity is performed. Where relevant, a legal representative will also sign the informed study consent according to local laws and regulations

Men or women at least 18 years of age at time of screening

Chronic plaque-type psoriasis diagnosed for at least 6 months before baseline

Moderate to severe psoriasis as defined at baseline by:
• PASI score of 10 or greater and,
• IGA score of 3 or greater (based on a scale of 0 - 4) and,
• BSA affected by plaque-type psoriasis of 10% or greater

Chronic plaque-type psoriasis patients who have previously received phototherapy or systemic psoriasis therapy at least once or who are candidates for such therapies in the opinion of the investigator
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 440
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 106

Exclusion Criteria

Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and guttate psoriasis)

Drug-induced psoriasis (i.e., new onset or current exacerbation from e.g. beta-blockers, or lithium)

Ongoing use of prohibited psoriasis treatments (e.g., topical or systemic corticosteroids, UV-therapy). Washout periods detailed in the protocol have to be adhered to

Ongoing use of other non-psoriasis prohibited treatments. Washout periods detailed in the protocol have to be adhered to. All other prior non-psoriasis concomitant treatments must be on a stable dose for at least four weeks before baseline

Previous exposure to etanercept

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified