Study Evaluating Enbrel In Adults With Active Rheumatoid Arthritis In Luxemburg

This study has been completed.

Sponsor:

Collaborator:

Innovex, Inc

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT00195338

First received: September 12, 2005

Last updated: December 16, 2011

Last verified: December 2011

History of Changes

Results First Received: December 16, 2011

Study Type:	Observational
Study Design:	Observational Model: Cohort; Time Perspective: Prospective
Condition:	Rheumatoid Arthritis
Intervention:	Drug: etanercept

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 (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.

Participant Flow: Overall Study

	Etanercept
STARTED	25
COMPLETED	13
NOT COMPLETED	12
Lost to Follow-up	2
Adverse Event	5
Lack of Efficacy	1
Early closure of the site	4

Baseline Characteristics

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Reporting Groups

	Description
Etanercept	Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.

Baseline Measures

	Etanercept
Number of Participants [units: participants]	25
Age [units: years] Mean ± Standard Deviation	50.20 ± 13.93
Gender [units: participants]
Female	20
Male	5

Outcome Measures

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1. Primary:

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 66 ]

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2. Secondary:

Percentage of Participants With Completion of Study Treatment [ Time Frame: Month 12 through Month 72 ]

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3. Secondary:

Change From Baseline in Number of Joints With Active Synovitis at Months 6, 12, 18, 30, 42, 54 and 66 [ Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66 ]

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4. Secondary:

Change From Baseline in Health Assessment Questionnaire (HAQ) Score at Months 6, 12, 18, 30, 42, 54 and 66 [ Time Frame: Baseline, Months 6, 12, 18, 30, 42, 54 and 66 ]

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5. Secondary:

Mean Dose of Concomitant Methotrexate (MTX) and Steroids [ Time Frame: Baseline up to Month 66 ]

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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: Pfizer 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:	Pfizer
ClinicalTrials.gov Identifier:	NCT00195338 History of Changes
Other Study ID Numbers:	0881-101343
Study First Received:	September 12, 2005
Results First Received:	December 16, 2011
Last Updated:	December 16, 2011
Health Authority:	European Union: European Medicines Agency

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