Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Wyeth

Status and phase: Completed; Phase 4

Conditions: Psoriatic Arthritis

Treatments: Drug: etanercept; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245960

0881A5-401

B1801271 (Other Identifier)

2005-001533-15 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 752 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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752 participants in 2 patient groups

A

Active Comparator group

Description:

Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW).

Treatment:

Drug: etanercept

Drug: etanercept

B

Active Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: etanercept

Drug: etanercept