Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Rheumatologists

This study is currently recruiting participants.

Verified by Wyeth, December 2007

First Received: February 15, 2006 Last Updated: December 19, 2007 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00293722

Purpose

The purpose of this study is to evaluate the safety and effectiveness of Etanercept under usual care settings in patients with PsA treated by rheumatologists.

Condition	Intervention
Arthritis, Psoriatic Psoriasis	Drug: etanercept

MedlinePlus related topics: Psoriasis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Prospective Post Marketing Surveillance to Evaluate the Safety and Efficacy of Etanercept Under Usual Care Settings in Patients With Psoriatic Arthritis (PsA) Treated by Rheumatologists

Further study details as provided by Wyeth:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	February 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

25mg administered twice weekly

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary care clinical and community sample

Criteria

Inclusion Criteria:

Clinical diagnosis of arthritis psoriatica

Exclusion Criteria:

Sepsis or risk for sepsis,
Acute infection,
Hypersensitivity against Etanercept

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293722

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Germany
	Recruiting
Munster, Germany, 48159

Sponsors and Collaborators

Wyeth

Investigators

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A6-102064
Study First Received:	February 15, 2006
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00293722 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Wyeth:

Arthritis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Spinal Diseases
Immunologic Factors
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
TNFR-Fc fusion protein
Immunosuppressive Agents
Bone Diseases
Musculoskeletal Diseases

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
TNFR-Fc fusion protein
Bone Diseases
Musculoskeletal Diseases
Psoriasis
Sensory System Agents
Arthritis
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Spondylarthritis

Spondylarthropathies
Spinal Diseases
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 07, 2009