Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

This study has been completed.

Study NCT00245960 Information provided by Wyeth

First Received: October 26, 2005 Last Updated: March 31, 2009 History of Changes

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

Participant Flow

Hide 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

Hide Baseline Characteristics

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

Show All Outcome Measures

1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

Show Outcome Measure 2