Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Phase 4

Completed

Brief Summary: The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

Recruitment & Eligibility

Inclusion Criteria

Inclusion Criteria:

18 years of age or older at time of consent
Active Psoriatic Arthritis
Clinically stable, plaque psoriasis involving more than 10% of the body surface area

Exclusion Criteria

Exclusion Criteria:

Evidence of skin conditions other than psoriasis that would interfere with skin examinations.
Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation
Prior exposure to any TNF-inhibitor, including etanercept

Arm && Interventions

Group	Intervention	Description
B	Placebo	Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24.
B	etanercept	Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24.
A	etanercept	Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).

Primary Outcome Measures

Name	Time	Method
Number of Patients Achieving "Clear" or "Almost Clear" on Physician Global Assessment (PGA) of Psoriasis	12 weeks	The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). "Clear" and "Almost Clear" includes all patients who were scored as a 0 or 1.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC)	12 and 24 weeks	The PsARC response was defined as improvement in at least 2 of the four criteria: \>=30% decrease in swollen joint count, \>=30% decrease in tender joint count, \>=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), \>=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Locations (112): Hospital A Posadas
🇦🇷
Palomar, Buenos Aires, Argentina
Hospital General de Agudos
🇦🇷
Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷
Buenos Aires, Argentina
CEMIC
🇦🇷
Buenos Aires, Argentina
Instituto de Medicina Cutanea
🇦🇷
Buenos Aires, Argentina
Goulburn Street Medical Centre
🇦🇺
Liverpool, New South Wales, Australia
St Vincent's Hospital VIC
🇦🇺
Fitzroy, Australia
Universitaetsklinik Graz
🇦🇹
Graz, SM, Austria
Krankenhaus Rudolfsstiftung
🇦🇹
Wien, Austria
Universitair Ziekenhuis Gent
🇧🇪
Gent, Belgium
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Hospital A Posadas
🇦🇷Palomar, Buenos Aires, Argentina