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

This study has been completed.

Sponsor:

Collaborator:

Centocor, Inc.

Information provided by:

Schering-Plough

ClinicalTrials.gov Identifier:

NCT00686595

First received: May 27, 2008

Last updated: April 4, 2011

Last verified: April 2011

History of Changes

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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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

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1. Primary:

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

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2. Secondary:

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

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3. Secondary:

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

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4. Secondary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

Percent Reduction in SKINDEX-29 Scores at Week 24 [ Time Frame: Baseline and Week 24 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Investigator agrees not to publish or publicly present any of the study results without prior written authorization from sponsor, except than for the dispositions provided in the Minister’s Decree and Ministerial Circular. Investigator agrees to provide 45 days written notice to sponsor prior to submission for publication or presentation to permit sponsor to review copies of abstracts/manuscripts for publication (including text for oral presentations) which report any study results.

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
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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:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
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:	April 4, 2011
Health Authority:	Italy: Ministry of Health

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