A Study to Evaluate the Switch From Etanercept to Infliximab in Subjects With Moderate-to-Severe Psoriasis (Study P05133) (TANGO)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00686595
First received: May 27, 2008
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: January 27, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Psoriasis
Intervention: Biological: Infliximab

  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
48 participants were enrolled in this study. Of these, 38 participants received at least one dose of the study medication and represent the intent-to-treat (ITT) population.

Reporting Groups
  Description
Infliximab 5 mg/kg Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).

Participant Flow:   Overall Study
    Infliximab 5 mg/kg  
STARTED     38  
COMPLETED     31  
NOT COMPLETED     7  
Adverse Event                 3  
Protocol Violation                 1  
Lost to Follow-up                 1  
Lack of Efficacy                 1  
Poor Compliance                 1  



  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
Infliximab 5 mg/kg Infliximab 5 mg/kg IV administered at Baseline (Week 0), Visit 3 (Week 2), Visit 4 (Week 6), Visit 6 (Week 14), and Visit 8 (Week 22).

Baseline Measures
    Infliximab 5 mg/kg  
Number of Participants  
[units: participants]
  38  
Age  
[units: years]
Mean ± Standard Deviation
  46.54  ± 9.70  
Gender  
[units: participants]
 
Female     10  
Male     28  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Psoriasis Area and Severity Index (PASI) 75 Response Rate at Week 10   [ Time Frame: Baseline and 10 weeks ]

2.  Secondary:   PASI 75 Response Rate at Week 18   [ Time Frame: Baseline and 18 weeks ]

3.  Secondary:   PASI 75 Response Rate at Week 24   [ Time Frame: Baseline and 24 weeks ]

4.  Secondary:   PASI 50 Response Rate at Week 10   [ Time Frame: Baseline and 10 weeks ]

5.  Secondary:   PASI 50 Response Rate at Week 18   [ Time Frame: Baseline and 18 weeks ]

6.  Secondary:   PASI 50 Response Rate at Week 24   [ Time Frame: Baseline and 24 weeks ]

7.  Secondary:   PASI 90 Response Rate at Week 10   [ Time Frame: Baseline and 10 weeks ]

8.  Secondary:   PASI 90 Response Rate at Week 18   [ Time Frame: Baseline and 18 weeks ]

9.  Secondary:   PASI 90 Response Rate at Week 24   [ Time Frame: Baseline and 24 weeks ]

10.  Secondary:   PASI 100 Response Rate at Week 10   [ Time Frame: Baseline and 10 weeks ]

11.  Secondary:   PASI 100 Response Rate at Week 18   [ Time Frame: Baseline and 18 weeks ]

12.  Secondary:   PASI 100 Response Rate at Week 24   [ Time Frame: 24 weeks ]

13.  Secondary:   Percent Reduction in Self-Administered Psoriasis Area Severity Index (SAPASI) at Week 18   [ Time Frame: Baseline and Week 18 ]

14.  Secondary:   Percent Reduction in SAPASI at Week 24   [ Time Frame: Baseline and Week 24 ]

15.  Secondary:   Percent Reduction in Affected Body Surface Area (BSA) at Week 18   [ Time Frame: Baseline and Week 18 ]

16.  Secondary:   Percent Reduction in Affected BSA at Week 24   [ Time Frame: Baseline and Week 24 ]

17.  Secondary:   Percent Reduction in Visual Analogue Scale (VAS) Referred Itch at Week 18   [ Time Frame: Baseline and Week 18 ]

18.  Secondary:   Percent Reduction in VAS Referred Itch at Week 24   [ Time Frame: Baseline and Week 24 ]

19.  Secondary:   Percent Reduction in Dermatology Life Quality Index (DLQI) Total Score at Week 18   [ Time Frame: Baseline and Week 18 ]

20.  Secondary:   Percent Reduction in DLQI Total Score at Week 24   [ Time Frame: Baseline and Week 24 ]

21.  Secondary:   Percent Reduction in Skin Index Questionnaire (SKINDEX-29) Score at Week 18   [ Time Frame: Baseline and Week 18 ]

22.  Secondary:   Percent Reduction in SKINDEX-29 Scores at Week 24   [ Time Frame: Baseline 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: Vice President of Late Stage Development
Organization: Merck Sharpe & Dohme Corp
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00686595     History of Changes
Other Study ID Numbers: P05133
Study First Received: May 27, 2008
Results First Received: January 27, 2011
Last Updated: December 17, 2013
Health Authority: Italy: Ministry of Health