Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis - Study Results

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment
Condition:	Psoriatic Arthritis
Intervention:	Drug: etanercept

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited worldwide from December 2005 to September 2007.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to 4 weeks.

Reporting Groups

	Description
Etanercept	Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
Etanercept and Placebo	Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.

Participant Flow: Overall Study

	Etanercept	Etanercept and Placebo
STARTED	379	373
COMPLETED	350	345
NOT COMPLETED	29	28
Adverse Event	14	10
Lost to Follow-up	2	2
Protocol Violation	4	3
Withdrawal by Subject	5	7
Lack of Efficacy	4	6

Baseline Characteristics

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Reporting Groups

	Description
Etanercept	Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
Etanercept and Placebo	Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.

Baseline Measures

	Etanercept	Etanercept and Placebo	Total
Number of Participants [units: participants]	379	373	752
Age [units: years] Mean ± Standard Deviation	46.11 ± 11.39	46.93 ± 11.41	46.52 ± 11.40
Gender [units: participants]
Female	136	143	279
Male	243	230	473

Outcome Measures

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1. Primary:

Efficacy of Two Different Treatment Regimens of Etanercept in Treating Skin Manifestations of Psoriasis Subjects With Psoriatic Arthritis. [ 12 weeks ]

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2. Secondary:

Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease. [ 24 weeks ]

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Measure Type	Secondary
Measure Title	Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.
Measure Description	Efficacy measured by the number of subjects achieving Psoriatic Arthritis response criteria at 24 weeks last observed carried forward (LOCF).
Time Frame	24 weeks
Safety Issue	No

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.
The analysis population was the Modified Intent to Treat (mITT).

Reporting Groups

	Description
Etanercept	Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
Etanercept and Placebo	Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.

Measured Values

	Etanercept	Etanercept and Placebo
Number of Participants Analyzed [units: participants]	372	372
Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease. [units: participants]	303	299

Statistical Analysis 1 for Efficacy of Two Different Treatment Regimens of Etanercept in Treating Joint Disease.

Groups ^[1]	All groups
Method ^[2]	Cochran-Mantel-Haenszel
P Value ^[3]	0.791
Risk Difference (RD) ^[4]	1.34

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
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[2]	Other relevant information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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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: The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

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: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A5-401
Study First Received:	October 26, 2005
Results First Received:	March 31, 2009
Last Updated:	March 31, 2009
ClinicalTrials.gov Identifier:	NCT00245960 History of Changes
Health Authority:	European Union: European Medicines Agency