Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel in Psoriasis

This study is ongoing, but not recruiting participants.

First Received: May 30, 2006 Last Updated: October 2, 2008 History of Changes

Sponsors and Collaborators:	Amgen Wyeth
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 Drug: Enbrel	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel in Psoriasis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by Amgen:

Primary Outcome Measures:

PHYSICIAN GLOBAL ASSESSMENT [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

QOL, Safety [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	March 2006
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ENBREL: No Intervention OPEN LABEL SINGLE ARM TREATMENT WITH ENBREL	Biological: ENBREL INTERVENTION WITH ENBREL IN SUBJECTS WITH PSORIASIS Drug: Enbrel ENBREL IN PSORIASIS Biological: ENBREL ENBREL IN PSORIASIS

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 Moderate to severe plaque psoriasis Able to start Enbrel therapy per the approved product monograph Exclusion Criteria Active infections Evidence of skin conditions other than psoriasis that would interfere with study evaluations Subjects receiving Remicade (infliximab), Humira (adalimumab) or Amevive (alefacept)

Contacts and Locations

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

Sponsors and Collaborators

Amgen

Wyeth

Investigators

Study Director:

Amgen

More Information

Additional Information:

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

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20050180
Study First Received:	May 30, 2006
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00332332 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by Amgen:

Phase IV
Psoriasis
Inflammation

Study placed in the following topic categories:

Anti-Inflammatory Agents
Skin Diseases
Immunologic Factors
TNFR-Fc fusion protein
Immunosuppressive Agents
Inflammation
Psoriasis

Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Skin Diseases, Papulosquamous

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Skin Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Psoriasis

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on July 02, 2009