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Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00111436
First Posted: May 23, 2005
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
  Purpose
The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.

Condition Intervention Phase
Psoriasis Drug: Etanercept Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject incidence of adverse events, including infectious episodes [ Time Frame: 72 weeks ]
  • Changes from baseline in laboratory values [ Time Frame: 72 weeks ]

Secondary Outcome Measures:
  • Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study [ Time Frame: 72 weeks ]
  • Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis [ Time Frame: 72 weeks ]
  • Patient Global Assessment of psoriasis [ Time Frame: 72 weeks ]
  • Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores [ Time Frame: 72 weeks ]
  • Changes from baseline in SF-36 Health Survey scores [ Time Frame: 72 weeks ]

Enrollment: 912
Study Start Date: April 2003
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg
50 mg once weekly
Drug: Etanercept
Enbrel 50 mg once weekly or 50 mg twice weekly
Experimental: 100 mg
50 mg twice weekly
Drug: Etanercept
Enbrel 50 mg once weekly or 50 mg twice weekly

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

Exclusion Criteria:

  • Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
  • Pregnant or breast-feeding females
  • Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00111436


Sponsors and Collaborators
Amgen
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111436     History of Changes
Other Study ID Numbers: 20030115
First Submitted: May 20, 2005
First Posted: May 23, 2005
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Amgen:
Psoriasis, adults, skin
Phase 3, clinical trial
Amgen, etanercept
Enbrel®, moderate
severe, extension

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors