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Study Evaluating Etanercept and Sulphasalazine in Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00247962
First received: October 31, 2005
Last updated: October 9, 2012
Last verified: October 2012
History of Changes
Results First Received: January 30, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Ankylosing Spondylitis
Interventions: Drug: etanercept
Drug: sulphasalazine (SSZ)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited in multiple countries from December 2005 to September 2007.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to 4 weeks in a 2:1 randomization ratio.

Reporting Groups
  Description
Etanercept etanercept 50 mg once weekly
Sulphasalazine Sulphasalazine (SSZ) titration up to 3 g daily

Participant Flow:   Overall Study
    Etanercept     Sulphasalazine  
STARTED     379     187  
COMPLETED     353     168  
NOT COMPLETED     26     19  
Adverse Event                 15                 12  
Lost to Follow-up                 3                 1  
Physician Decision                 0                 1  
Protocol Violation                 1                 1  
Withdrawal by Subject                 3                 2  
Lack of Efficacy                 4                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Etanercept etanercept 50 mg once weekly
Sulphasalazine Sulphasalazine (SSZ) titration up to 3 g daily
Total Total of all reporting groups

Baseline Measures
    Etanercept     Sulphasalazine     Total  
Number of Participants  
[units: participants]
 		  379     187     566  
Age  
[units: years]
Mean ± Standard Deviation 		  40.69  ± 11.69     40.90  ± 12.23     40.76  ± 11.86  
Gender  
[units: participants]
 		     
Female     100     47     147  
Male     279     140     419  
Region of Enrollment  
[units: participants]
 		     
Qatar     7     3     10  
Switzerland     2     1     3  
Finland     11     3     14  
Spain     12     7     19  
Ireland     1     0     1  
Austria     3     1     4  
Italy     19     8     27  
United Kingdom     38     19     57  
France     4     1     5  
Czech Republic     36     18     54  
Hungary     27     15     42  
Poland     30     15     45  
Australia     5     2     7  
Denmark     13     6     19  
Netherlands     7     4     11  
Germany     62     31     93  
China     17     9     26  
Sweden     4     2     6  
Greece     4     3     7  
Serbia     54     27     81  
Mexico     11     6     17  
Colombia     8     4     12  
Portugal     4     2     6  



  Outcome Measures
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1.  Primary:   Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS 20)   [ Time Frame: 16 weeks ]
  Show Outcome Measure 1

2.  Secondary:   Ankylosing Spondylitis Quality of Life (ASQoL) Total Score Change From Baseline   [ Time Frame: Baseline and 16 Weeks ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Publications automatically indexed to this study:


Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00247962     History of Changes
Other Study ID Numbers: 0881A3-402
Study First Received: October 31, 2005
Results First Received: January 30, 2009
Last Updated: October 9, 2012
Health Authority: European Union: European Medicines Agency