Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

Wyeth

Status and phase: Completed; Phase 4

Conditions: Plaque Psoriasis; Nail Psoriasis

Treatments: Drug: etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00581100

0881A6-409

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

1

Active Comparator group

Description:

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

Treatment:

Drug: etanercept

2

Active Comparator group

Description:

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

Treatment:

Drug: etanercept