Study Evaluating Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

This study is ongoing, but not recruiting participants.

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00195364

Purpose

The purpose of this study is to evaluate long-term safety of etanercept in patients with rheumatoid arthritis who successfully have completed open-label safety study 0881A1-301-EU

Condition	Intervention	Phase
Rheumatoid Arthritis Inflammation	Drug: Etanercept	Phase IV

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Retrospective Study
Official Title:	Long-Term Safety Study of Etanercept in Patients With Rheumatoid Arthritis Who Completed Trial 0881A1-301-EU in Spain

Further study details as provided by Wyeth:

Estimated Enrollment:	93
Study Start Date:	July 2003

Eligibility

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

Criteria

Inclusion Criteria:

To have completed 0881A1-301-EU study in Spain
Clinical diagnosis by ACR revised criteria of rheumatoid arthritis.

Exclusion Criteria:

Hypersensibility to etanercept or any of its components
Significant concurrent medical disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00195364

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0881A1-301, 101492
Study First Received:	September 13, 2005
Last Updated:	May 18, 2006
ClinicalTrials.gov Identifier:	NCT00195364
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases

Arthritis, Rheumatoid
Rheumatic Diseases
TNFR-Fc fusion protein
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Pathologic Processes

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

ClinicalTrials.gov processed this record on January 16, 2009