Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 31, 2005

Last Updated Date

July 25, 2008

Start Date ^ICMJE

December 2005

Primary Completion Date

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

Current Primary Outcome Measures ^ICMJE

To compare the efficacy of etanercept with sulphasalazine in the treatment of ankylosing spondylitis. [ Time Frame: 22 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

To compare the efficacy of etanercept with sulphasalzine in the treatment of ankylosing spondylitis.

Change History

Complete list of historical versions of study NCT00247962 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the effect of etanercept with sulphasalazine on the quality of life. To evaluate the safety of etanercept. [ Time Frame: 22 Weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To compare the effect of etanercept with sulphasalazine on the quality of life. To evaluate the safety of etanercept.

Descriptive Information

Brief Title ^ICMJE

Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

Official Title ^ICMJE

A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis

Brief Summary

The purpose of this study is to compare the efficacy of etanercept and sulphasalazine in the treatment of Ankylosing Spondylitis.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Ankylosing Spondylitis

Intervention ^ICMJE

Drug: etanercept
Drug: sulphasalazine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

540

Completion Date

February 2008

Primary Completion Date

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

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of ankylosing spondylitis
Active ankylosing spondylitis

Exclusion Criteria:

Complete ankylosis of spine
Previous treatment with etanercept

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

Australia, Austria, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Poland, Qatar, Saudi Arabia, Spain, Sweden, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00247962

Responsible Party

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

Study ID Numbers ^ICMJE

0881A3-402

Study Sponsor ^ICMJE

Wyeth

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Medical Monitor	Wyeth
Principal Investigator:	Trial Manager	For Poland, WPWZMED@wyeth.com
Principal Investigator:	Trial Manager	For Italy, descresg@wyeth.com
Principal Investigator:	Trial Manager	For Hungary, WPBUMED@wyeth.com
Principal Investigator:	Trial Manager	For Czech Republic, WPPGCLI@wyeth.com
Principal Investigator:	Trial Manager	For Australia, medinfo@wyeth.com
Principal Investigator:	Trial Manager	For Germany, medinfoDEU@wyeth.com
Principal Investigator:	Trial Manager	For Austria, WPVIMED@wyeth.com
Principal Investigator:	Trial Manager	For Spain, infomed@wyeth.com
Principal Investigator:	Trial Manager	For Netherlands, trials-NL@wyeth.com
Principal Investigator:	Trial Manager	For Denmark, medinfonord@wyeth.com
Principal Investigator:	Trial Manager	For Finland, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For Sweden, MedInfoNord@wyeth.com
Principal Investigator:	Trial Manager	For UK/Great Britian, ukmedinfo@wyeth.com
Principal Investigator:	Trial Manager	For Ireland, ukmedinfo@wyeth.com
Principal Investigator:	Trial Manager	For France, infomedfrance@wyeth.com
Principal Investigator:	Trial Manager	For China, medinfo@wyeth.com

Information Provided By

Wyeth

Verification Date

July 2008

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