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

This study has been completed.
Sponsor:
Collaborators:
Immunex Corporation
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00111436
First received: May 20, 2005
Last updated: April 24, 2013
Last verified: April 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]
  • Changes from baseline in laboratory values [ Time Frame: 72 weeks ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Patient Global Assessment of psoriasis [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Changes from baseline in SF-36 Health Survey scores [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 20, 2005
Last Updated: April 24, 2013
Health Authority: United States: Food and Drug Administration

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
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014