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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00247962
Date of registration:	31/10/2005
Prospective Registration:	Yes
Primary sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Public title:	Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis
Scientific title:	A Randomized, Double-Blind Study Evaluating the Safety and Efficacy of Etanercept and Sulphasalazine in Subjects With Ankylosing Spondylitis
Date of first enrolment:	December 2005
Target sample size:	566
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00247962
Study type:	Interventional
Study design:
Phase:	Phase 4

Countries of recruitment
Australia	Austria	China	Czech Republic	Denmark	Finland	France	Germany
Greece	Hungary	Ireland	Italy	Netherlands	Poland	Portugal	Qatar
Saudi Arabia	Spain	Sweden	Switzerland	United Kingdom

Contacts

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Australia, medinfo@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Austria, WPVIMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
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Affiliation:	For Czech Republic, WPPGCLI@wyeth.com

Name:	Trial Manager
Address:
Telephone:
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Affiliation:	For France, infomedfrance@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Ireland, ukmedinfo@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Poland, WPWZMED@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For UK/Great Britian, ukmedinfo@wyeth.com

Name:	Trial Manager
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Telephone:
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Affiliation:	For Sweden, MedInfoNord@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Netherlands, trials-NL@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Spain, infomed@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Denmark, medinfonord@wyeth.com

Name:	Trial Manager
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Affiliation:	For Italy, descresg@wyeth.com

Name:	Trial Manager
Address:
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Email:
Affiliation:	For China, medinfo@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Finland, MedInfoNord@wyeth.com

Name:	Trial Manager
Address:
Telephone:
Email:
Affiliation:	For Germany, medinfoDEU@wyeth.com

Name:	Medical Monitor
Address:
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Affiliation:	Wyeth is now a wholly owned subsidiary of Pfizer

Name:	Trial Manager
Address:
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Email:
Affiliation:	For Hungary, WPBUMED@wyeth.com

Key inclusion & exclusion criteria

Inclusion Criteria:

- Clinical diagnosis of ankylosing spondylitis

- Active ankylosing spondylitis

Exclusion Criteria:

- Complete ankylosis of spine

- Previous treatment with etanercept

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: etanercept

Drug: sulphasalazine (SSZ)

Primary Outcome(s)

Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20) [Time Frame: 16 weeks]

Secondary Outcome(s)

Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline [Time Frame: Baseline and 16 Weeks]

Secondary ID(s)

0881A3-402

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:	Yes
Date Posted:	08/11/2012
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00247962

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