Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

This study has been completed.

Sponsor:

Collaborator:

Immunex Corporation

Information provided by (Responsible Party):

Amgen

ClinicalTrials.gov Identifier:

NCT00356590

First received: July 24, 2006

Last updated: May 10, 2013

Last verified: May 2013

History of Changes

Results First Received: November 5, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Rheumatoid Arthritis
Intervention:	Biological: 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
Participants were enrolled from 3 March 1999 through 17 Mar 2000

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Participant Flow: Overall Study

	Etanercept (Enbrel)
STARTED	468
COMPLETED	194
NOT COMPLETED	274
Adverse Event	54
Death	10
Lost to Follow-up	35
Physician Decision	46
Withdrawal by Subject	41
Completed month 12 only	2
Protocol issues	6
Response status	28
Other	52

Baseline Characteristics

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Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Baseline Measures

	Etanercept (Enbrel)
Number of Participants [units: participants]	468
Age [units: Year] Mean ± Standard Deviation	51.38 ± 12.38
Gender [units: Participant]
Female	351
Male	117
Race/Ethnicity, Customized [units: Participant]
Hispanic or Latino	25
White or Caucasian	407
Other	4
American Indian or Alaska Native	4
Asian	5
Black or African American	23
Physician Global Assessment of Disease Status ^[1] [units: Units on a scale] Mean ± Standard Deviation	5.32 ± 2.30
Participant Global Assessment of Disease Status ^[1] [units: Units on a scale] Mean ± Standard Deviation	5.51 ± 2.27
Participant Pain Visual Analog Scale ^[2] [units: Units on a scale] Mean ± Standard Deviation	5.01 ± 2.62
Tender Joint Count ^[3] [units: Joints] Mean ± Standard Deviation	25.81 ± 16.71
Swollen Joint Count ^[4] [units: Joints] Mean ± Standard Deviation	20.30 ± 12.60
Health Assessment Questionnaire Disability Index ^[5] [units: Units on a scale] Mean ± Standard Deviation	1.30 ± 0.67
Physical Component Summary Score from SF-36 ^[6] [units: Units on a scale] Mean ± Standard Deviation	30.42 ± 9.69
Mental Component Summary Score from SF-36 ^[7] [units: Units on a scale] Mean ± Standard Deviation	48.28 ± 11.52
C-Reactive Protein [units: mg/dL] Mean ± Standard Deviation	3.28 ± 4.90
Duration of Morning Stiffness [units: Minutes] Mean ± Standard Deviation	182.24 ± 286.63

[1]	Assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
[2]	Assessed using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).
[3]	Based on up to 71 joints
[4]	Based on up to 68 joints
[5]	This index is a weighted average of 24 items, each scored 0 (no difficulty) to 3 (unable to function).
[6]	Physical Component Summary Score from the Short Form-36 Health Survey. This score has a range of 0 to 100, with higher scores indicating better health.
[7]	Mental Component Summary Score from the Short Form-36 Health Survey. This score has a range of 0 to 100, with higher scores indicating better health.

Outcome Measures

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1. Primary:

Total Exposure to Etanercept With Gaps [ Time Frame: Up to 8 years ]

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2. Primary:

Total Exposure-Adjusted Rate of Malignancies [ Time Frame: Up to 8 years ]

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3. Primary:

Total Exposure-Adjusted Rate of Deaths [ Time Frame: Up to 8 years ]

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4. Primary:

Total Exposure Adjusted Rate of Serious Infectious Events [ Time Frame: Up to 8 years ]

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5. Primary:

Total Exposure Adjusted Rate of Lymphomas [ Time Frame: Up to 8 years ]

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6. Primary:

Malignancy [ Time Frame: Up to 8 years ]

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7. Primary:

Lymphoma [ Time Frame: Up to 8 years ]

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8. Primary:

Serious Infectious Event [ Time Frame: Up to 8 years ]

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9. Primary:

Total Exposure Adjusted Rate of Serious Adverse Events [ Time Frame: Up to 8 years ]

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10. Primary:

Death [ Time Frame: Up to 8 years ]

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11. Secondary:

ACR20 Response at Month 3 [ Time Frame: Baseline and month 3 ]

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12. Secondary:

Dosing Period [ Time Frame: Up to 8 years ]

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13. Secondary:

ACR20 Response at Month 12 [ Time Frame: Baseline and month 12 ]

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Measure Type	Secondary
Measure Title	ACR20 Response at Month 12
Measure Description	American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Time Frame	Baseline and month 12
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.
All enrolled participants who received at least one dose of etanercept and had available data at month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	424
ACR20 Response at Month 12 [units: Participants]	262

No statistical analysis provided for ACR20 Response at Month 12

14. Secondary:

ACR50 Response at Month 12 [ Time Frame: Baseline and month 12 ]

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15. Secondary:

ACR70 Response at Month 12 [ Time Frame: Baseline and month 12 ]

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16. Secondary:

Standardized Incidence Rate for All SEER Cancers [ Time Frame: Up to 8 years ]

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17. Secondary:

Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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18. Secondary:

Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 [ Time Frame: Baseline and Month 12 ]

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19. Secondary:

Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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20. Secondary:

Percent Improvement in Tender Joint Count From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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21. Secondary:

Percent Improvement in Swollen Joint Count From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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22. Secondary:

Percent Improvement in HAQ DI From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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23. Secondary:

Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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24. Secondary:

Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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25. Secondary:

Percent Improvement in C-Reactive Protein From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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26. Secondary:

Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 [ Time Frame: Baseline and month 12 ]

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27. Secondary:

Change From Baseline to Year 2 in Total Sharp Score [ Time Frame: Baseline, Year 2 ]

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28. Secondary:

Change From Baseline to Year 2 in Sharp Score Erosion Subscale [ Time Frame: Baseline, Year 2 ]

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29. Secondary:

Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale [ Time Frame: Baseline, Year 2 ]

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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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multi-center studies, the investigator agrees not to publish any results before the first 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
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Amgen Inc.
phone: 866-572-6436

Publications of Results:

Genovese MC, Bathon JM, Fleischmann RM, Moreland LW, Martin RW, Whitmore JB, Tsuji WH, Leff JA. Longterm safety, efficacy, and radiographic outcome with etanercept treatment in patients with early rheumatoid arthritis. J Rheumatol. 2005 Jul;32(7):1232-42.

Genovese MC, Bathon JM, Martin RW, Fleischmann RM, Tesser JR, Schiff MH, Keystone EC, Wasko MC, Moreland LW, Weaver AL, Markenson J, Cannon GW, Spencer-Green G, Finck BK. Etanercept versus methotrexate in patients with early rheumatoid arthritis: two-year radiographic and clinical outcomes. Arthritis Rheum. 2002 Jun;46(6):1443-50.

Publications automatically indexed to this study:

Weinblatt ME, Bathon JM, Kremer JM, Fleischmann RM, Schiff MH, Martin RW, Baumgartner SW, Park GS, Mancini EL, Genovese MC. Safety and efficacy of etanercept beyond 10 years of therapy in North American patients with early and longstanding rheumatoid arthritis. Arthritis Care Res (Hoboken). 2011 Mar;63(3):373-82. doi: 10.1002/acr.20372. Epub 2010 Oct 18.

Responsible Party:	Amgen
ClinicalTrials.gov Identifier:	NCT00356590 History of Changes
Other Study ID Numbers:	20021623, 16.0023
Study First Received:	July 24, 2006
Results First Received:	November 5, 2010
Last Updated:	May 10, 2013
Health Authority:	Canada: Health Canada United States: Food and Drug Administration United States: Western Institutional Review Board

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