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 ]

Measure Type	Primary
Measure Title	Total Exposure to Etanercept With Gaps
Measure Description	Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Time Frame	Up to 8 years
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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Total Exposure to Etanercept With Gaps [units: Participant-years]	2882.50

No statistical analysis provided for Total Exposure to Etanercept With Gaps

2. Primary:

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

Measure Type	Primary
Measure Title	Total Exposure-Adjusted Rate of Malignancies
Measure Description	Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Total Exposure-Adjusted Rate of Malignancies [units: Malignancies per 100 participant-years]	1.32

No statistical analysis provided for Total Exposure-Adjusted Rate of Malignancies

3. Primary:

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

Measure Type	Primary
Measure Title	Total Exposure-Adjusted Rate of Deaths
Measure Description	Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Total Exposure-Adjusted Rate of Deaths [units: Deaths per 100 participant-years]	0.35

No statistical analysis provided for Total Exposure-Adjusted Rate of Deaths

4. Primary:

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

Measure Type	Primary
Measure Title	Total Exposure Adjusted Rate of Serious Infectious Events
Measure Description	Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Total Exposure Adjusted Rate of Serious Infectious Events [units: Events per 100 participant-years]	2.88

No statistical analysis provided for Total Exposure Adjusted Rate of Serious Infectious Events

5. Primary:

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

Measure Type	Primary
Measure Title	Total Exposure Adjusted Rate of Lymphomas
Measure Description	Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Total Exposure Adjusted Rate of Lymphomas [units: Lymphomas per 100 participant-years]	0.24

No statistical analysis provided for Total Exposure Adjusted Rate of Lymphomas

6. Primary:

Malignancy [ Time Frame: Up to 8 years ]

Measure Type	Primary
Measure Title	Malignancy
Measure Description	Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Malignancy [units: Participants]	31

No statistical analysis provided for Malignancy

7. Primary:

Lymphoma [ Time Frame: Up to 8 years ]

Measure Type	Primary
Measure Title	Lymphoma
Measure Description	Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Lymphoma [units: Participants]	6

No statistical analysis provided for Lymphoma

8. Primary:

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

Measure Type	Primary
Measure Title	Serious Infectious Event
Measure Description	Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Serious Infectious Event [units: Participants]	51

No statistical analysis provided for Serious Infectious Event

9. Primary:

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

Measure Type	Primary
Measure Title	Total Exposure Adjusted Rate of Serious Adverse Events
Measure Description	Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure * 100)
Time Frame	Up to 8 years
Safety Issue	Yes

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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Total Exposure Adjusted Rate of Serious Adverse Events [units: Events per 100 patient-years]	13.84

No statistical analysis provided for Total Exposure Adjusted Rate of Serious Adverse Events

10. Primary:

Death [ Time Frame: Up to 8 years ]

Measure Type	Primary
Measure Title	Death
Measure Description	Death of the participant on study up to 30 days after the last dose of etanercept
Time Frame	Up to 8 years
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

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Death [units: Participants]	10

No statistical analysis provided for Death

11. Secondary:

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

Measure Type	Secondary
Measure Title	ACR20 Response at Month 3
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 (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)
Time Frame	Baseline and month 3
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 3

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	450
ACR20 Response at Month 3 [units: Participants]	276

No statistical analysis provided for ACR20 Response at Month 3

12. Secondary:

Dosing Period [ Time Frame: Up to 8 years ]

Measure Type	Secondary
Measure Title	Dosing Period
Measure Description	Duration of etanercept dosing
Time Frame	Up to 8 years
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 participants who received at least one dose of etanercept

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Dosing Period [units: Days] Mean ± Standard Deviation	2249.6 ± 1180.00

No statistical analysis provided for Dosing Period

13. Secondary:

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

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 ]

Measure Type	Secondary
Measure Title	ACR50 Response at Month 12
Measure Description	American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% 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
ACR50 Response at Month 12 [units: Participants]	192

No statistical analysis provided for ACR50 Response at Month 12

15. Secondary:

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

Measure Type	Secondary
Measure Title	ACR70 Response at Month 12
Measure Description	American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% 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
ACR70 Response at Month 12 [units: Participants]	110

No statistical analysis provided for ACR70 Response at Month 12

16. Secondary:

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

Measure Type	Secondary
Measure Title	Standardized Incidence Rate for All SEER Cancers
Measure Description	Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.
Time Frame	Up to 8 years
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 participants who received at least one dose of etanercept

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	468
Standardized Incidence Rate for All SEER Cancers [units: Standardized incidence rate] Mean ( 95% Confidence Interval )	0.99 ( 0.67 to 1.42 )

No statistical analysis provided for Standardized Incidence Rate for All SEER Cancers

17. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
Measure Description	Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	417
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	50.07 ± 58.07

No statistical analysis provided for Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12

18. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
Measure Description	Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	419
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	35.46 ± 60.62

No statistical analysis provided for Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12

19. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
Measure Description	Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from "no pain" (0 cm) to "severe pain" (10 cm).
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	422
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	30.64 ± 103.25

No statistical analysis provided for Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12

20. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Tender Joint Count From Baseline to Month 12
Measure Description	Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	417
Percent Improvement in Tender Joint Count From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	49.70 ± 147.16

No statistical analysis provided for Percent Improvement in Tender Joint Count From Baseline to Month 12

21. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Swollen Joint Count From Baseline to Month 12
Measure Description	Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	412
Percent Improvement in Swollen Joint Count From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	52.04 ± 87.97

No statistical analysis provided for Percent Improvement in Swollen Joint Count From Baseline to Month 12

22. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in HAQ DI From Baseline to Month 12
Measure Description	Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	420
Percent Improvement in HAQ DI From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	40.91 ± 66.09

No statistical analysis provided for Percent Improvement in HAQ DI From Baseline to Month 12

23. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
Measure Description	Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	422
Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	-39.65 ± 55.43

No statistical analysis provided for Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12

24. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
Measure Description	Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	422
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	-12.31 ± 31.48

No statistical analysis provided for Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12

25. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in C-Reactive Protein From Baseline to Month 12
Measure Description	Percent improvement in C-reactive protein from baseline to month 12
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	423
Percent Improvement in C-Reactive Protein From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	31.57 ± 132.83

No statistical analysis provided for Percent Improvement in C-Reactive Protein From Baseline to Month 12

26. Secondary:

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

Measure Type	Secondary
Measure Title	Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
Measure Description	Percent improvement in the duration of morning stiffness from baseline to month 12
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 for this outcome measure at baseline and month 12

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	411
Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 [units: Percent change] Mean ± Standard Deviation	44.08 ± 156.20

No statistical analysis provided for Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12

27. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline to Year 2 in Total Sharp Score
Measure Description	Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.
Time Frame	Baseline, Year 2
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 for this outcome measure at baseline and year 2

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	274
Change From Baseline to Year 2 in Total Sharp Score [units: Units on a scale] Mean ( Full Range )	1.17 ( -10.10 to 32.72 )

No statistical analysis provided for Change From Baseline to Year 2 in Total Sharp Score

28. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline to Year 2 in Sharp Score Erosion Subscale
Measure Description	Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.
Time Frame	Baseline, Year 2
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 for this outcome measure at baseline and year 2

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	274
Change From Baseline to Year 2 in Sharp Score Erosion Subscale [units: Units on a scale] Mean ( Full Range )	0.54 ( -8.08 to 20.83 )

No statistical analysis provided for Change From Baseline to Year 2 in Sharp Score Erosion Subscale

29. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
Measure Description	Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.
Time Frame	Baseline, Year 2
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 for this outcome measure at baseline and year 2

Reporting Groups

	Description
Etanercept (Enbrel)	Etanercept 50 mg subcutaneous dose weekly

Measured Values

	Etanercept (Enbrel)
Number of Participants Analyzed [units: participants]	274
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale [units: Units on a scale] Mean ( Full Range )	0.64 ( -5.04 to 16.31 )

No statistical analysis provided for Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale

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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