Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis

This study has been terminated.

( The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug. )

Study NCT00273858 Information provided by Wyeth is now a wholly owned subsidiary of Pfizer

First Received on January 4, 2006. Last Updated on September 8, 2011 History of Changes

Results First Received: June 30, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Conditions:	Ankylosing Spondylitis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis, Ankylosing
Intervention:	Other: There is no Intervention. The study is observational.

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
Etanercept	Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.

Participant Flow: Overall Study

	Etanercept
STARTED	880
COMPLETED	343
NOT COMPLETED	537
Not completed 24 month observation time	334
Lost to Follow-up	101
Withdrawal by Subject	21
Adverse Event	81

Baseline Characteristics

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Reporting Groups

	Description
Etanercept	Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.

Baseline Measures

	Etanercept
Number of Participants [units: participants]	880
Age ^[1] [units: Years] Mean ± Standard Deviation	52.0 ± 13.6
Gender [units: Participants]
Female	562
Male	318

[1]	Mean age of the participants is based on N=795.

Outcome Measures

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1. Primary:

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 24 ]

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2. Primary:

Number of Participants Who Discontinued Treatment [ Time Frame: Baseline up to Month 24 ]

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3. Primary:

Number of Participants by Reasons for Discontinuation of Treatment [ Time Frame: Baseline up to Month 24 ]

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4. Secondary:

Change From Baseline in Health Assessment Questionnaire (HAQ) at 24 Month [ Time Frame: Baseline, Month 24 ]

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5. Secondary:

Change From Baseline in Patient Global Assessment (PtGA) Visual Analog Scale (VAS) at 24 Month [ Time Frame: Baseline, Month 24 ]

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6. Secondary:

Change From Baseline in Physician Global Assessment (PGA) VAS at 24 Month [ Time Frame: Baseline, Month 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: Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than 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: 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:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00273858 History of Changes
Other Study ID Numbers:	0881A-101695, B1801106
Study First Received:	January 4, 2006
Results First Received:	June 30, 2011
Last Updated:	September 8, 2011
Health Authority:	Greece: National Organization of Medicines