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Trial record 39 of 381 for:    Ankylosing Spondylitis

Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy (ASSIAL)

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ClinicalTrials.gov Identifier: NCT01856569
Recruitment Status : Completed
First Posted : May 17, 2013
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Other
Condition: Ankylosing Spondylitis
Intervention: Other: no intervention

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Anti-Tumor Necrosis Factor (Anti-TNF) Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.

Participant Flow:   Overall Study
    Anti-Tumor Necrosis Factor (Anti-TNF)
STARTED   152 
Full Analysis Set   144 
COMPLETED   139 
NOT COMPLETED   13 
Other                1 
Changed Site/Structure                1 
Lost to Follow-up                3 
Did not met inclusion criteria                8 



  Baseline Characteristics

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.
Full analysis set (FAS) included all participants who met the inclusion criteria.

Reporting Groups
  Description
Anti-Tumor Necrosis Factor (Anti-TNF) Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.

Baseline Measures
   Anti-Tumor Necrosis Factor (Anti-TNF) 
Overall Participants Analyzed 
[Units: Participants]
 144 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.85  (12.46) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      53  36.8% 
Male      91  63.2% 


  Outcome Measures

1.  Primary:   Percentage of Participants With Unchanged First Line Anti-TNF Treatment Up to Month 18   [ Time Frame: Baseline up to Month 18 ]

2.  Primary:   Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score at Month 18   [ Time Frame: Baseline, Month 18 ]

3.  Primary:   Percentage of Participants With Unchanged First Line Anti-TNF Treatment In State of Low Disease Activity   [ Time Frame: Month 12, 18 ]

4.  Secondary:   Ankylosing Spondylitis Quality of Life (ASQoL) Total Score at Month 18   [ Time Frame: Month 18 ]

5.  Secondary:   C Reactive Protein Level at Baseline   [ Time Frame: Baseline ]

6.  Secondary:   Erythrocyte Sedimentation Rate at Baseline   [ Time Frame: Baseline ]


  Serious Adverse Events


  Other Adverse Events


  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
Data for change from baseline in ASQoL score was not collected as per change in planned analyses.


  More Information

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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01856569     History of Changes
Other Study ID Numbers: B1801362
B1801362
First Submitted: May 14, 2013
First Posted: May 17, 2013
Results First Submitted: January 19, 2017
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017