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Observational Non-Interventional Study With Enbrel (Etanercept) in Patients With Ankylosing Spondylitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01188655
First received: August 24, 2010
Last updated: September 8, 2011
Last verified: September 2011
Results First Received: March 29, 2011  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Spondylitis, Ankylosing
Intervention: Drug: Enbrel

  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
Etanercept Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.

Participant Flow:   Overall Study
    Etanercept
STARTED   89 
COMPLETED   76 
NOT COMPLETED   13 
Lack of Efficacy                1 
Lost to Follow-up                1 
Unspecified                11 



  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
Etanercept Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.

Baseline Measures
   Etanercept 
Overall Participants Analyzed 
[Units: Participants]
 89 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.6  (11.7) 
Gender 
[Units: Participants]
 
Female   32 
Male   57 
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.3  (1.6) 
[1] BASDAI is a validated self assessment tool used to determine disease activity in participant with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) participant's answered 6 questions measuring discomfort, pain and fatigue. Number of participants analyzed for BASDAI (n)= 84
Bath Ankylosing Spondylitis Functional Index (BASFI) at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.7  (2.3) 
[1] BASFI is a validated self assessment tool that determines the degree of functional limitation in AS. Utilizing a VAS of 0-10 (0 = easy, 10 =impossible), participants answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. Number of participants analyzed for BASFI (n)= 83
Participant's Global Assessment Visual Analog Scale at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 6.7  (2.0) 
[1] Measured using a 100mm Visual Analog Scale (VAS) ranging from 0=very good to 100=very bad. Number of participants analyzed for Participant’s Global Assessment VAS (n)= 84
Physician's Global Assessment Visual Analog Scale at baseline [1] 
[Units: Mm]
Mean (Standard Deviation)
 6.6  (1.4) 
[1] Physician Global Assessment of Disease Activity was measured on a 0 to 100 mm Visual Analog Scale (VAS), with 0 mm = no disease activity.
Duration of morning stiffness at baseline [1] 
[Units: Minutes]
Mean (Standard Deviation)
 88.3  (67.5) 
[1] Duration of morning stiffness is defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness in minutes. Number of participants analyzed for morning stiffness (n)= 80
Ankylosing Spondylitis Quality of Life Scale (ASQoL) at baseline [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.9  (3.9) 
[1] ASQoL is a questionnaire consisting of 18 statements, related to mobility, self-care, usual activities, pain/discomfort and anxiety/depression, relevant to the physical and mental conditions of the participant with AS, to assess disease-specific quality of life. Score range: 0 (good)-18 (poor). Number of participants analyzed for ASQoL (n)= 77
Percentage of Participants Without Enthesitis [1] 
[Units: Percentage of Participants]
 57.5 
[1] Number of participants analyzed for Enthesitis (n)= 87
Percentage of Participants Without Peripheral Arthritis [1] 
[Units: Percentage of Participants]
 70.1 
[1] Number of participants analyzed for Peripheral Arthritis (n)= 87
Occiput-to-wall distance [1] 
[Units: Centimeter (cm)]
Mean (Standard Deviation)
 3.8  (6.0) 
[1] Number of participants analyzed for occiput-to-wall distance (n)= 67
Spine agility function by Schober test [1] 
[Units: Cm]
Mean (Standard Deviation)
 6.3  (5.5) 
[1] Schober test determines agility of lumbar spine. It measures participant’s ability to flex lower back. Examiner makes mark at fifth lumbar vertebra (L5); places 1 finger 5 cm below and another 10 cm above the mark. Participant is asked to touch toes. Examiner measures increase in distance between 2 fingers. Number of participants analyzed (n)= 58.
Spine agility function by Ott test [1] 
[Units: Cm]
Mean (Standard Deviation)
 11.8  (14.3) 
[1] The Ott index determines the agility of the thoracic spine. Number of participants analyzed for Ott test (n)= 48


  Outcome Measures
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1.  Primary:   Percentage of Participants Achieving BASDAI 40 Response at Week 24   [ Time Frame: Week 24 ]

2.  Secondary:   Change From Baseline in BASDAI at Week 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

3.  Secondary:   Change From Baseline in the BASFI at Weeks 12 and 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

4.  Secondary:   Participant's Global Assessment Visual Analog Scale at Weeks 12 and 24   [ Time Frame: Week 12 and Week 24 ]

5.  Secondary:   Physician's Global Assessment Visual Analog Scale at Weeks 12 and 24   [ Time Frame: Week 12 and Week 24 ]

6.  Secondary:   Mean Duration of Morning Stiffness   [ Time Frame: Week 12 and Week 24 ]

7.  Secondary:   Change From Baseline in ASQoL at Week 12 and Week 24   [ Time Frame: Baseline, Week 12 and Week 24 ]

8.  Secondary:   Percentage of Participants Without Enthesitis   [ Time Frame: Week 12 and Week 24 ]

9.  Secondary:   Percentage of Participants Without Peripheral Arthritis   [ Time Frame: Week 12 and Week 24 ]

10.  Secondary:   Mean Occiput-to-wall Distance at Week 12 and Week 24   [ Time Frame: Week 12 and Week 24 ]

11.  Secondary:   Spine Agility Function by Schober Test   [ Time Frame: Week 12 and Week 24 ]

12.  Secondary:   Spine Agility Function by Ott Test   [ Time Frame: Week 12 and Week 24 ]


  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



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01188655     History of Changes
Other Study ID Numbers: 0881X1-4456
B1801095
Study First Received: August 24, 2010
Results First Received: March 29, 2011
Last Updated: September 8, 2011
Health Authority: Austria: Federal Office for Safety in Health Care