Effects of Etanercept on Nail Psoriasis and Plaque Psoriasis

NCT00581100 | Completed Phase 4 Results

• 1 other identifier: 0881A6-409
• Study Type: interventional
• Target: 136
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nail Psoriasis; Plaque Psoriasis

Keywords

Nail Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail

  Target fingernail (highest matrix + bed scores at baseline) divided with imaginary lines into quadrants and graded for nail matrix and nail bed psoriasis. Sum of scores = total score for that nail (0-8). Nail Matrix Psoriasis = pitting, leukonychia, red spots in lunula, and/or nail plate crumbling. Nail Bed Psoriasis = onycholysis, splinter hemorrhages, oil drop (salmon patch) discoloration, and/or nail bed hyperkeratosis. Range for both scores: 0 (none), 1 (present in 1/4 nail), 2 (present in 2/4 nail), 3 (present in 3/4 nail), 4 (present in 4/4 nail). Higher scores = more severe psoriasis.

  Baseline, Week 24

Secondary Outcomes (15)

• Change From Baseline in Overall Nail Psoriasis Severity Index (NAPSI) Score

  Baseline, Week 24

• Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24

  Week 12, Week 24

• Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) Score for Target Fingernail at Week 12 and Week 24

  Week 12, Week 24

• Percent of Participants Who Achieved a 50% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24

  Week 12, Week 24

• Percent of Participants Who Achieved a 75% Improvement in the Nail Psoriasis Severity Index (NAPSI) for Overall NAPSI Score at Week 12 and Week 24

  Week 12, Week 24

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: etanercept

2

ACTIVE COMPARATOR

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

Drug: etanercept

Interventions

etanercept 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.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Interventions

Etanercept

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 27, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: February 25, 2013
• Results First Posted: August 30, 2010

Record last verified: 2013-02