Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00293709
First received: February 15, 2006
Last updated: January 10, 2014
Last verified: January 2014
Results First Received: January 10, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Arthritis, Psoriatic
Psoriasis
Skin Diseases, Papulosquamous
Intervention: Drug: etanercept

  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
Participants With Psoriatic Arthritis Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.

Participant Flow:   Overall Study
    Participants With Psoriatic Arthritis  
STARTED     149  
COMPLETED     102  
NOT COMPLETED     47  
Unspecified                 47  



  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.
Safety analysis set included all participants who were enrolled in this study. Out of a total of 149 participants, data for baseline measure (age) was available only for 146 participants.

Reporting Groups
  Description
Participants With Psoriatic Arthritis Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.

Baseline Measures
    Participants With Psoriatic Arthritis  
Number of Participants  
[units: participants]
  149  
Age  
[units: years]
Mean ± Standard Deviation
  50.0  ± 12.2  
Gender  
[units: participants]
 
Female     70  
Male     79  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Baseline up to Week 52 ]

2.  Secondary:   Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52   [ Time Frame: Baseline, Week 52 ]

3.  Secondary:   Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52   [ Time Frame: Baseline, Week 52 ]

4.  Secondary:   Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52   [ Time Frame: Baseline, Week 52 ]

5.  Secondary:   Change From Baseline in Ritchie Index at Week 52   [ Time Frame: Baseline, Week 52 ]

6.  Secondary:   Change From Baseline in Physician Global Assessment of Disease Activity at Week 52   [ Time Frame: Baseline, Week 52 ]

7.  Secondary:   Number of Participants With Nail Involvement   [ Time Frame: Baseline, Week 12, 52 ]

8.  Secondary:   Change From Baseline in C-reactive Protein (CRP) at Week 52   [ Time Frame: Baseline, Week 52 ]

9.  Secondary:   Change From Baseline in Patient Assessment of Itching at Week 52   [ Time Frame: Baseline, Week 52 ]

10.  Secondary:   Change From Baseline in Patient Assessment of Pain at Week 52   [ Time Frame: Baseline, Week 52 ]

11.  Secondary:   Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52   [ Time Frame: Baseline, Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  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: 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: NCT00293709     History of Changes
Other Study ID Numbers: 0881A6-102036, B1801126
Study First Received: February 15, 2006
Results First Received: January 10, 2014
Last Updated: January 10, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices