Trial record 1 of 1 for: NCT00245934

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Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00245934

Recruitment Status : Completed

First Posted : October 28, 2005

Last Update Posted : December 14, 2007

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

First Submitted Date

October 26, 2005

First Posted Date

October 28, 2005

Last Update Posted Date

December 14, 2007

Study Start Date

June 2003

Primary Completion Date

Not Provided

Current Primary Outcome Measures

Not Provided

Original Primary Outcome Measures

Not Provided

Change History

Current Secondary Outcome Measures

Not Provided

Original Secondary Outcome Measures

Not Provided

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title

Study Evaluating Enbrel in Patients With Rheumatoid Arthritis

Official Title

Observational Study With Enbrel in Patients With Rheumatoid Arthritis

Brief Summary

The purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated.

Detailed Description

Not Provided

Study Type

Observational

Study Design

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Not Provided

Study Population

Not Provided

Condition

Rheumatoid Arthritis

Intervention

Drug: Enbrel

Study Groups/Cohorts

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status

Completed

Enrollment

1500

Original Enrollment

Same as current

Actual Study Completion Date

July 2005

Primary Completion Date

Not Provided

Eligibility Criteria

Inclusion Criteria:

Proven diagnosis of rheumatoid arthritis

Exclusion Criteria:

Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the following points will prevent or restrict participation:
- Patients who suffer from hypersensitivity to the active substance Etanercept or to any of the excipients of Enbrel®
- Treatment with Enbrel® should not be initiated in patients with active infections including chronic or localized infections
- Patients with sepsis or risk of sepsis should not be treated

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Contacts

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries

Not Provided

Removed Location Countries

Administrative Information

NCT Number

NCT00245934

Other Study ID Numbers

101354

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

Not Provided

Investigators

Study Director:	Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator:	Trial Manager	For Germany, MedinfoDEU@wyeth.com

PRS Account

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

December 2007

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