Study Investigating Enbrel Treatment for Ankylosing Spondylitis

This study has been completed.

Sponsor:

Information provided by:

Wyeth is now a wholly owned subsidiary of Pfizer

ClinicalTrials.gov Identifier:

NCT00195416

First received: September 12, 2005

Last updated: September 15, 2009

Last verified: September 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 15, 2009

Start Date ^ICMJE

June 2005

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00195416 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study Investigating Enbrel Treatment for Ankylosing Spondylitis

Official Title ^ICMJE

A Drug Use Investigation of Enbrel for Post-marketing Surveillance (PMS) for Ankylosing Spondylitis

Brief Summary

To identify the following problems and questions with respect to the safety and effectiveness of Enbrel during the post-marketing period as required by Korea Food and Drug Administration (KFDA)'s regulations.

Unknown adverse reactions, especially serious adverse reactions
Change of the incidences of adverse reactions under the routine drug uses
Factors that may affect the safety of the drug
Factors that may affect the effectiveness of the drug

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic, secondary and tertiary medical centers

Condition ^ICMJE

Ankylosing Spondylitis

Intervention ^ICMJE

Drug: Etanercept

Etanercept 25mg Injection, 2 times/week

Study Group/Cohort (s)

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 ^ICMJE

Completed

Enrollment ^ICMJE

526

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adults: Severe ankylosing spondylitis (AS) in patients who do not respond adequately to previous therapy

Exclusion Criteria:

Patients with known hypersensitivity to Enbrel or any component of the product
Patients with sepsis or risk of sepsis
Patients with active infections including chronic or localized infections such as tuberculosis.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT Number ^ICMJE

NCT00195416

Other Study ID Numbers ^ICMJE

0881A-102018

Has Data Monitoring Committee

Responsible Party

Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth

Study Sponsor ^ICMJE

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

Information Provided By

Wyeth is now a wholly owned subsidiary of Pfizer

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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