Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis - Full Text View

Sponsor:	Amgen
Collaborator:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00332332

Purpose

The purpose of this study is to evaluate the use of Enbrel® (etanercept) in the treatment of psoriasis in patients for a period of up to 1 year.

Condition	Intervention	Phase
Psoriasis	Biological: ENBREL (entanercept)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis

Resource links provided by NLM:

Genetics Home Reference related topics: psoriatic arthritis

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

Status of Mild or Better on Physician Global Assessment at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
Status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) at month 12. This scale ranges from 0 to 5, with 0 = best outcome.

Secondary Outcome Measures:

Percent Change From Baseline to Month 12 in Patient Global Assessment [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Percent change from baseline to month 12 in the Patient Global Assessment of psoriasis score. This score ranged from 0 (good) to 5 (severe).
Percent Change From Baseline to Month 12 in Body Surface Area [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Percent change from baseline to month 12 in body surface area (BSA) affected by psoriasis.
Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
Percent change from baseline to month 12 in the Dermatology Life Quality Index (DLQI) total score. This score ranges from 0 to 30, with 0 = no effect and 30 = large effect.

Enrollment:	230
Study Start Date:	March 2006
Study Completion Date:	February 2010
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: ENBREL (Etanercept) OPEN LABEL SINGLE ARM TREATMENT WITH ENBREL (Etanercept)	Biological: ENBREL (entanercept) INTERVENTION WITH ENBREL (Etanercept) IN SUBJECTS WITH PSORIASIS Open label, Enbrel (Etanercept) 50 mg twice weekly SC for 3 months followed by 50 mg twice a week week SC for 9 months, for a total treatment period of 12 months

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older at baseline
Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
Able to start Enbrel (Etanercept) therapy per the approved product monograph

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332332

Sponsors and Collaborators

Amgen

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

MD

Amgen

More Information

Additional Information:

Notice regarding posted summaries of trial results This link exits the ClinicalTrials.gov site

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier:	NCT00332332 History of Changes
Other Study ID Numbers:	20050180
Study First Received:	May 30, 2006
Results First Received:	November 5, 2010
Last Updated:	June 3, 2011
Health Authority:	Canada: Health Canada

Keywords provided by Amgen:

Phase IV
Psoriasis
Inflammation

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 February 12, 2012