Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

NCT ID: NCT00581100

Last Updated: 2013-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-10-31

Brief Summary

The purpose of this study is to evaluate if Etanercept administered at a higher initial dose provides greater improvement in nail and skin psoriasis symptoms than a regimen with a lower initial dose.

Detailed Description

This study will assess the effects of the 2 Etanercept regimens on fingernail psoriasis over 24 weeks among patients with both skin and fingernail symptoms who have previously failed at least one therapy for nail psoriasis. The endpoint of 24 weeks was chosen to allow sufficient time for normal nail growth.

Conditions

Nail Psoriasis; Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

etanercept 50 mg SC injection twice weekly for 12 weeks reducing to etanercept 50 mg once weekly to week 24

Group Type: ACTIVE_COMPARATOR

etanercept

Intervention Type: DRUG

Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.

Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.

2

etanercept 50 mg SC once weekly for the complete 24 week treatment period

Group Type: ACTIVE_COMPARATOR

etanercept

Intervention Type: DRUG

Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.

Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.

Interventions

etanercept

Subjects randomized to Arm 1 shall be treated with ETN 50 mg twice weekly for 12 weeks reducing thereafter to ETN 50 mg once weekly to 24 weeks.

Subjects randomized to Arm 2 shall be treated with ETN 50 mg once weekly for the entire 24 week treatment period.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 18 years of age or older
• Active, stable plaque psoriasis defined by the following criteria:

• Body surface area (BSA) ≥ 10 % at screening and baseline
• Or, PASI >10 at screening and baseline
• Or, PGA of Psoriasis status of moderate or worse (moderate, marked, or severe) at screening and baseline
• Or, DLQI > 10 at baseline
• Active fingernail psoriasis defined as target fingernail NAPSI ≥ 2 and overall NAPSI > 14 - Target nail is defined as the nail with the highest nail score (matrix+bed scores) at baseline. Should more than one fingernail have the same score, the target fingernail will be chosen by the investigator.
• Failure of at least one systemic psoriasis therapy for nail psoriasis
• Eligible to receive biologic therapy for psoriasis in accordance to local guidelines

Exclusion Criteria

• Evidence of Skin conditions other than psoriasis
• Psoralen plus ultraviolet radiation (PUVA), cyclosporine, alefacept, methotrexate, acitretin, or any other systemic anti-psoriasis therapy within 28 days of study drug initiation
• Prior exposure to any TNF-inhibitor. Prior exposure to efalizumab

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

0881A6-409

Identifier Type: -

Identifier Source: org_study_id