Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00111449
First received: May 20, 2005
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.


Condition Intervention Phase
Psoriasis
Drug: Etanercept
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.

Secondary Outcome Measures:
  • Dermatology Live Quality Index (DLQI) response at week 12
  • Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
  • Psoriasis pain (VAS) at week 12
  • Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
  • PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
  • Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
  • Adverse events, infections injection site reactions during long-term therapy
  • Serious adverse events and infections during long-term therapy
  • Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy

Estimated Enrollment: 600
Study Start Date: June 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an 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: NCT00111449

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00111449     History of Changes
Other Study ID Numbers: 20030117
Study First Received: May 20, 2005
Last Updated: May 13, 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

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 18, 2014