Study to Help Understand the Action of the Drug Etanercept for the Adult Patient With Psoriasis

NCT00116181 | Completed Phase 3

• 1 other identifier: JKR 542
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator's laboratory is studying a skin disease known as psoriasis. The purpose of this protocol is to study the action and the effects of Etanercept, on psoriasis. This medication has been studied extensively and has been found to be effective and safe in the treatment of psoriasis. The eligible patient will have 10% of his/her body surface area involved with psoriasis vulgaris. This trial is a phase III study to help understand the action of the drug etanercept, trade name Enbrel, for the adult patient with moderate to severe plaque psoriasis and who is a candidate for internal medications.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving a responder status on the Physician's Global Assessment (PGA) at week 24

  screening, baseline, week 2, 4, 12, 16, 20 and 24

Secondary Outcomes (1)

• Subject incidence rates of serious adverse events, serious infections, non-melanoma skin cancer, and all malignancies

  measured over 24 weeks

Study Arms (2)

continuous therapy

EXPERIMENTAL

Subjects will receive 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) for weeks 13 through 24.

Drug: Etanercept

intermittent therapy

ACTIVE COMPARATOR

Subjects who achieve a responder status on the PGA (PGA score £ 2 and improved from baseline) at week 12 will discontinue therapy. Upon relapse of PGA responder status, etanercept will be administered 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) through week 24.

Drug: Etanercept

Interventions

Etanercept DRUG

All subjects will administer etanercept 50 mg twice weekly subcutaneously (2 injections of 25 mg etanercept SC within 1 hour twice weekly) for the first 12 weeks of study. Subjects randomized to the "continuous therapy" arm will then receive 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) for weeks 13 through 24. Subjects randomized to the "intermittent therapy" arm will be assessed for response. Those who achieve a responder status on the PGA (PGA score £ 2 and improved from baseline) at week 12 will discontinue therapy. Upon relapse of PGA responder status, etanercept will be administered 50 mg once weekly SC (2 injections of 25 mg etanercept SC within 1 hour once weekly) through week 24.

continuous therapy; intermittent therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: Male and Female
• Minimum Age: 18
• Maximum Age: 70

You may not qualify if:

• Healthy Volunteers

Sponsors & Collaborators

• Rockefeller University: lead
• Amgen: collaborator

Study Sites (1)

Rockefeller University

New York, New York, 10021, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Psoriasis

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

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

Study Officials

• James G. Krueger, MD, PHD

  Rockefeller University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 27, 2005
• First Posted: June 28, 2005
• Study Start: October 1, 2004
• Primary Completion: January 1, 2007
• Last Updated: March 18, 2011

Record last verified: 2011-03

Locations

US (1)