Study Evaluating Predictors of Response in Patients With Ankylosing Spondylitis (PRETEA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00900796
First received: May 11, 2009
Last updated: May 7, 2012
Last verified: May 2012
Results First Received: May 7, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Ankylosing Spondylitis
Intervention: Other: Treatment switching

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Anti-tumor Necrosis Factor Agents Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.

Participant Flow for 3 periods

Period 1:   Phase 1
    Anti-tumor Necrosis Factor Agents  
STARTED     132  
COMPLETED     121  
NOT COMPLETED     11  
Lacked sufficient information                 4  
Missing information at Week 16                 7  

Period 2:   Between Phase 1 and Phase 2
    Anti-tumor Necrosis Factor Agents  
STARTED     121  
COMPLETED     11  
NOT COMPLETED     110  
Responded to therapy- ineligible for Ph2                 110  

Period 3:   Phase 2
    Anti-tumor Necrosis Factor Agents  
STARTED     11  
COMPLETED     6  
NOT COMPLETED     5  
Lost to Follow-up                 5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Anti-tumor Necrosis Factor Agents (Evaluable Population) Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.

Baseline Measures
    Anti-tumor Necrosis Factor Agents (Evaluable Population)  
Number of Participants  
[units: participants]
  121  
Age  
[units: years]
Mean ± Standard Deviation
  42.7  ± 11.6  
Gender  
[units: participants]
 
Female     36  
Male     85  



  Outcome Measures
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1.  Primary:   Percentage of Participants With a Clinical Response   [ Time Frame: Week 16 ]

2.  Secondary:   Percentage of Participants With High Probability of Response and no Response Who Received Second Anti-TNF Treatment   [ Time Frame: Week 32 ]

3.  Secondary:   Percentage of Participants With Low Probability of Response and no Response Who Received Second Anti-TNF Treatment   [ Time Frame: Week 32 ]

4.  Secondary:   Percentage of Participants With Low Probability of Response and a Clinical Response at Week 16   [ Time Frame: Week 16 ]

5.  Secondary:   Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16   [ Time Frame: Week 16 ]

6.  Secondary:   Percentage of Participants Who Switched to Another Anti-TNF Treatment Due to Lack of Efficacy   [ Time Frame: Week 16 ]

7.  Secondary:   Percentage of Participants With ASAS 40 Response Who Started Second Anti-TNF Treatment and Were Treated for at Least 16 Weeks   [ Time Frame: Week 32 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00900796     History of Changes
Other Study ID Numbers: 0881A3-4452, B1801100
Study First Received: May 11, 2009
Results First Received: May 7, 2012
Last Updated: May 7, 2012
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios