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Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

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ClinicalTrials.gov Identifier: NCT01313208
Recruitment Status : Completed
First Posted : March 11, 2011
Results First Posted : June 17, 2014
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: etanercept
Drug: Placebo
Drug: DMARD Therapy
Enrollment 210

Recruitment Details First patient enrolled on 31 March 2011; Last patient enrolled 29 November 2012
Pre-assignment Details  
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.

Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.

All participants continued their DMARD treatment throughout the 24-week study period.

Period Title: Double-blind Phase (Weeks 1 - 12)
Started 104 106
Completed 98 101
Not Completed 6 5
Reason Not Completed
Withdrawal by Subject             3             2
Adverse Event             1             2
Ineligibility determined             0             1
Lost to Follow-up             1             0
Noncompliance             1             0
Period Title: Open-label Phase (Weeks 13 - 24)
Started 98 101
Completed 92 98
Not Completed 6 3
Reason Not Completed
Withdrawal by Subject             3             1
Noncompliance             0             2
Adverse Event             1             0
Other             2             0
Arm/Group Title Placebo Etanercept Total
Hide Arm/Group Description Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.

Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.

All participants continued their DMARD treatment throughout the 24-week study period.

Total of all reporting groups
Overall Number of Baseline Participants 104 106 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 106 participants 210 participants
55.5  (12.8) 56.5  (12.1) 56.0  (12.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 210 participants
Female
86
  82.7%
75
  70.8%
161
  76.7%
Male
18
  17.3%
31
  29.2%
49
  23.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 210 participants
American Indian or Alaska Native 1 0 1
Asian 3 2 5
Black or African American 8 9 17
Mixed race 1 0 1
White 90 91 181
Other 1 4 5
Duration of Rheumatoid Arthritis  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 106 participants 210 participants
7.41  (8.11) 8.26  (11.16) 7.84  (9.76)
Baseline methotrexate use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 104 participants 106 participants 210 participants
Yes 93 94 187
No 11 12 23
1.Primary Outcome
Title Percentage of Participants Achieving DAS28 Low Disease Activity at Week 12
Hide Description

Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: • The number of swollen and tender joints assessed using the 28-joint count; • C-Reactive Protein (CRP) level • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).

The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set (all randomized participants); last observation carried forward (LOCF) imputation was used.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
21.2 33.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Etanercept
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.055
Comments [Not Specified]
Method Mantel Haenszel
Comments P-value from Mantel-Haenszel test stratified by participant's baseline methotrexate use (yes or no).
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.83
Confidence Interval (2-Sided) 95%
0.99 to 3.41
Estimation Comments Etanercept/Placebo
2.Secondary Outcome
Title Percentage of Participants Achieving DAS28 Remission at Week 12
Hide Description

Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • C-reactive protein (CRP)
  • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).

The DAS28 score ranges from zero to ten. DAS28 above 5.1 indicates high disease activity.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
11.5 18.9
3.Secondary Outcome
Title Percentage of Participants Achieving DAS28 Low Disease Activity at All Other Timepoints
Hide Description

Low disease activity is defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) of less than 3.2. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • C-Reactive Protein (CRP) level
  • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).

The DAS28 score ranges from zero up to approximately ten. DAS28 scores above 5.1 indicate high disease activity.

Time Frame Baseline and Weeks 2, 4, 8, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analysis at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=104, 104) 2.9 1.0
Week 2 (N=99, 105) 10.1 21.0
Week 4 (N=104, 106) 15.4 24.5
Week 8 (N=104, 106) 16.3 34.0
Week 16 (N=104, 106) 37.5 40.6
Week 20 (N=104, 106) 46.2 45.3
Week 24 (N=104, 106) 43.3 50.0
4.Secondary Outcome
Title Percentage of Participants Achieving DAS28 Remission at All Other Timepoints
Hide Description

Remission is defined by a DAS28 score less than 2.6. The DAS28 is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables:

  • The number of swollen and tender joints assessed using the 28-joint count;
  • C-reactive protein (CRP)
  • Patient's global assessment of disease activity measured on a likert scale from 0 (no activity at all) to 10 (worst activity).

The DAS28 score ranges from zero to ten. A DAS28 above 5.1 indicates high disease activity.

Time Frame Baseline and Weeks 2, 4, 8, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=104, 104) 1.0 0.0
Week 2 (N=99, 105) 5.1 8.6
Week 4 (N=104, 106) 6.7 11.3
Week 8 (N=104, 106) 5.8 25.5
Week 16 (N=104, 106) 22.1 25.5
Week 20 (N=104, 106) 29.8 26.4
Week 24 (N=104, 106) 32.7 31.1
5.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 20 Response at Each Timepoint
Hide Description A participant was a responder if the following 3 criteria for improvement from Baseline were met: • ≥ 20% improvement in tender joint count; • ≥ 20% improvement in swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-Reactive Protein level.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants with available data at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (N=101, 105) 14.9 28.6
Week 4 (N=104, 106) 19.2 36.8
Week 8 (N=104, 106) 23.1 50.0
Week 12 (N=104, 106) 28.8 40.6
Week 16 (N=104, 106) 47.1 49.1
Week 20 (N=104, 106) 54.8 51.9
Week 24 N=104, 106) 46.2 50.0
6.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 50 Response at Each Timepoint
Hide Description

A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 50% improvement in tender joint count;
  • ≥ 50% improvement in swollen joint count; and
  • ≥ 50% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
    • Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • C-reactive protein (CRP) level.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants with available data at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (N=101, 106) 3.0 5.7
Week 4 (N=104, 106) 4.8 13.2
Week 8 (N=104, 106) 4.8 19.8
Week 12, (N=104, 106) 12.5 20.8
Week 16 (N=104, 106) 22.1 30.2
Week 20 (N=104, 106) 28.8 29.2
Week 24 (N=104, 106) 28.8 33.0
7.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR) 70 Response at Each Timepoint
Hide Description

A participant was a responder if the following 3 criteria for improvement from Baseline were met:

  • ≥ 70% improvement in tender joint count;
  • ≥ 70% improvement in swollen joint count; and
  • ≥ 70% improvement in at least 3 of the 5 following parameters:

    • Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]);
    • Patient's global assessment of disease activity (measured on a likert scale from 0 to 10);
    • Physician's global assessment of disease activity (measured on a likert scale from 0 to 10);
    • Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]);
    • C-reactive protein (CRP) level.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants with available data at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Week 2 (N=101, 106) 0.0 1.9
Week 4 (N=104, 106) 0.0 1.9
Week 8 (N=104, 106) 0.0 5.7
Week 12, (N=104, 106) 1.0 5.7
Week 16 (N=104, 106) 9.6 8.5
Week 20 (N=104, 106) 10.6 17.0
Week 24 (N=104, 106) 12.5 16.0
8.Secondary Outcome
Title Percentage of Participants With RAPID3 Remission or Low Severity at Each Time Point
Hide Description The Multi-Dimensional Health Assessment Questionnaire (MDHAQ) is adapted from the standard HAQ and is used for the computation of the Routine Assessment of Patient Index Data 3 (RAPID3). The RAPID 3 includes the 3 Core Data Set measures of physical function, pain, and patient global estimate. The score for physical function ranges from 0 to 10 and is calculated by adding the ten activities of daily living, each scored from 0 to 3 by the patient (0="without any difficulty", 1="with some difficulty", 2="with much difficulty", and 3="unable to do") and dividing the total raw score by 3. Pain and global estimate of health are measured on a likert scale from 0 to 10, both scored 0 (best) to 10 (worst). The three 0-10 scores for physical function, pain, and global assesment of health are added together for a composite score of 0 to 30. The RAPID3 composite score includes 4 categories: High Severity > 12, Moderate Severity = 6.1 - 12, Low severity = 3.1 - 6, and Remission ≤ 3.
Time Frame Baseline and Weeks 4, 12, and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=96, 99) 9.4 9.1
Week 4 (N=95, 99) 21.1 30.3
Week 12 (N=102, 103) 21.6 39.8
Week 24 (N=103, 103) 41.7 46.6
9.Secondary Outcome
Title Percentage of Participants Achieving Count Remission at Each Time Point
Hide Description Count remission is achieved when a participant satisfies all of the following at any given time point: - 68 tender joint count ≤ 1, - 66 swollen joint count ≤ 1, - C-reactive protein (CRP) (in mg/dL) ≤1, and - patient global assessment of disease activity ≤ 1 (measured on a likert scale from 0 to 10 ranging from "no activity at all" to "worst activity imaginable").
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=104, 106) 0.0 0.0
Week 2 (N=101, 106) 1.0 0.0
Week 4 (N=104, 106) 0.0 2.8
Week 8 (N=104, 106) 0.0 2.8
Week 12 (N=104, 106) 1.9 4.7
Week 16 (N=104, 106) 3.8 5.7
Week 20 (N=104, 106) 5.8 10.4
Week 24 (N=104, 106) 7.7 10.4
10.Secondary Outcome
Title Percentage of Participants Achieving CDAI Remission at Each Time Point
Hide Description

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:

  • 28 tender joint count (TJC),
  • 28 swollen joint count (SJC),
  • Patient's Global Assessment of Disease Activity measured on a likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;
  • Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest.

The CDAI score ranges from 0-76 where lower scores indicate less disease activity. CDAI remission is defined as a score ≤ 2.8.

Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=101, 101) 0.0 0.0
Week 2 (N=99, 106) 1.0 1.9
Week 4 (N=104, 106) 0.0 0.9
Week 8 (N=104, 106) 0.0 2.8
Week 12 (N=104, 106) 1.0 3.8
Week 16 (N=104, 106) 3.8 7.5
Week 20 (N=104, 106) 6.7 10.4
Week 24 (N=104, 106) 3.8 8.5
11.Secondary Outcome
Title Percentage of Participants Achieving CDAI Low Disease Activity at Each Time Point
Hide Description

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:

  • 28 tender joint count (TJC),
  • 28 swollen joint count (SJC),
  • Patient's Global Assessment of Disease Activity measured on a Likert scale form 0 to 10, where 0 = lowest disease activity and 10 = highest;
  • Physician's Global Assessment of Disease Activity -measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest. The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity. CDAI low disease activity is defined as a score ≤ 10.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=101, 101) 0.0 0.0
Week 2 (N=99, 106) 9.1 12.3
Week 4 (N=104, 106) 16.3 18.9
Week 8 (N=104, 106) 15.4 29.2
Week 12 (N=104, 106) 21.2 25.5
Week 16 (N=104, 106) 32.7 35.8
Week 20 (N=104, 106) 42.3 38.7
Week 24 (N=104, 106) 41.3 46.2
12.Secondary Outcome
Title Clinical Disease Activity Index (CDAI) Score at Each Time Point
Hide Description

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the:

  • 28 tender joint count (TJC),
  • 28 swollen joint count (SJC),
  • Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest;
  • Physician's Global Assessment of Disease Activity (measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest).

The CDAI score ranges from 0 to 76 where lower scores indicate less disease activity.

Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (N=101, 101) 30.18  (9.30) 29.79  (9.08)
Week 2 (N=99, 106) 26.67  (12.89) 24.32  (12.94)
Week 4 (N=104, 106) 24.81  (12.76) 21.56  (12.82)
Week 8 (N=104, 106) 22.83  (12.25) 20.22  (13.96)
Week 12 (N=104, 106) 22.79  (14.07) 20.68  (14.90)
Week 16 (N=104, 106) 18.03  (12.34) 18.28  (15.16)
Week 20 (N=104, 106) 15.13  (10.80) 17.47  (14.90)
Week 24 (N=104, 106) 16.33  (11.85) 16.86  (14.74)
13.Secondary Outcome
Title Percentage of Participants Achieving SDAI Remission at Each Time Point
Hide Description

The simplified disease activity index (SDAI) is a composite measure that sums the total number of:

  • 28 tender joint counts,
  • 28 swollen joint counts,
  • Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0= lowest disease activity and 10 = highest;
  • Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and
  • C-reactive protein (CRP) in mg/dL.

The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI remission is defined as a score ≤ 3.3.

Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=101, 101) 0.0 0.0
Week 2 (N=97, 105) 1.0 1.0
Week 4 (N=104, 106) 1.0 0.9
Week 8 (N=104, 106) 0.0 5.7
Week 12 (N=104, 106) 1.9 5.7
Week 16 (N=104, 106) 4.8 8.5
Week 20 (N=104, 106) 8.7 11.3
Week 24 (N=104, 106) 6.7 10.4
14.Secondary Outcome
Title Percentage of Participants Achieving SDAI Low Disease Activity at Each Time Point
Hide Description The simplified disease activity index (SDAI) is a composite measure that sums the total number of: - 28 tender joint counts, - 28 swollen joint counts, - Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10 where 0 = lowest disease activity and 10 = highest, and - C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity. SDAI low disease activity is defined as a score ≤ 11.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Measure Type: Number
Unit of Measure: percentage of participants
Baseline (N=101, 101) 0.0 0.0
Week 2 (N=97, 105) 8.2 12.4
Week 4 (N=104, 106) 13.5 18.9
Week 8 (N=104, 106) 14.4 30.2
Week 12 (N=104, 106) 21.2 23.6
Week 16 (N=104, 106) 32.7 35.8
Week 20 (N=104, 106) 42.3 38.7
Week 24 (N=104, 106) 39.4 45.3
15.Secondary Outcome
Title Simplified Clinical Disease Activity Index (SDAI) Score at Each Time Point
Hide Description

The simplified disease activity index (SDAI) is a composite measure that sums the total number of:

  • 28 tender joint counts,
  • 28 swollen joint counts,
  • Patient's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest;
  • Physician's Global Assessment of Disease Activity measured on a Likert scale from 0 to 10, where 0 = lowest disease activity and 10 = highest, and
  • C-reactive protein (CRP) in mg/dL.

The SDAI score ranges from 0 to approximately 86 where lower scores indicate less disease activity.

Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (N=101, 101) 31.00  (9.49) 30.56  (9.01)
Week 2 (N=97, 105) 27.83  (12.89) 24.77  (12.96)
Week 4 (N=104, 106) 25.81  (12.89) 22.00  (12.86)
Week 8 (N=104, 106) 23.64  (12.32) 20.51  (14.08)
Week 12 (N=104, 106) 23.52  (14.02) 21.09  (15.05)
Week 16 (N=104, 106) 18.55  (12.43) 18.68  (15.25)
Week 20 (N=104, 106) 15.61  (10.77) 17.87  (14.98)
Week 24 (N=104, 106) 16.93  (11.90) 17.30  (14.85)
16.Secondary Outcome
Title Tender 28-Joint Count (TJC28) at Each Time Point
Hide Description Twenty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: tender joints
Baseline (N=104, 106) 11.1  (5.5) 10.6  (5.1)
Week 2 (N=101, 106) 10.1  (6.7) 9.6  (7.6)
Week 4 (N=104, 106) 9.4  (6.9) 8.4  (6.9)
Week 8 (N=104, 106) 8.0  (6.2) 7.7  (7.7)
Week 12 (N=104, 106) 8.8  (7.0) 8.1  (8.0)
Week 16 (N=104, 106) 6.6  (6.3) 6.9  (7.9)
Week 20 (N=104, 106) 5.1  (5.3) 6.5  (7.9)
Week 24 (N=104, 106) 6.0  (6.4) 6.5  (7.9)
17.Secondary Outcome
Title Swollen 28-Joint Count (SJC28) at Each Time Point
Hide Description Twenty-eight joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: swollen joints
Baseline (N=104, 106) 8.5  (4.4) 8.4  (5.0)
Week 2 (N=101, 106) 6.9  (5.4) 6.7  (4.5)
Week 4 (N=104, 106) 6.7  (5.3) 5.4  (4.6)
Week 8 (N=104, 106) 6.2  (4.9) 5.4  (4.9)
Week 12 (N=104, 106) 5.7  (5.4) 5.5  (4.9)
Week 16 (N=104, 106) 5.0  (4.5) 5.2  (5.4)
Week 20 (N=104, 106) 4.4  (4.7) 4.8  (4.9)
Week 24 (N=104, 106) 4.6  (4.7) 4.6  (5.2)
18.Secondary Outcome
Title Patient Global Assessment of Joint Pain at Each Time Point
Hide Description The severity of the participant’s joint pain was assessed using a visual analog scale (VAS). The participant was asked to draw a mark through a 100 mm horizontal line to indicate how much pain they were experiencing “today", from ‘0’ (no pain at all) on the left end of the line to 100 (worst pain imaginable) on the right end of the line.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (N=104, 106) 43.74  (23.05) 47.13  (23.22)
Week 2 (N=101, 106) 40.98  (23.58) 33.41  (22.77)
Week 4 (N=104, 106) 38.65  (23.42) 35.75  (24.92)
Week 8 (N=104, 106) 38.16  (23.64) 31.18  (25.44)
Week 12 (N=104, 106) 38.38  (24.52) 31.54  (26.46)
Week 16 (N=104, 106) 25.80  (20.52) 28.97  (24.37)
Week 20 (N=104, 106) 23.98  (20.36) 27.74  (25.83)
Week 24 (N=104, 106) 25.43  (22.12) 28.09  (26.26)
19.Secondary Outcome
Title Patient's Global Assessment of Disease Activity at Each Time Point
Hide Description The participant’s global assessment of their arthritis disease activity was assessed by the participant circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (N=104, 106) 5.0  (2.2) 5.3  (2.1)
Week 2 (N=101, 106) 4.7  (2.3) 4.0  (2.1)
Week 4 (N=104, 106) 4.5  (2.2) 4.1  (2.3)
Week 8 (N=104, 106) 4.6  (2.3) 3.7  (2.4)
Week 12 (N=104, 106) 4.3  (2.4) 3.7  (2.5)
Week 16 (N=104, 106) 3.3  (2.2) 3.3  (2.3)
Week 20 (N=104, 106) 2.9  (2.2) 3.2  (2.6)
Week 24 (N=104, 106) 3.1  (2.2) 3.1  (2.6)
20.Secondary Outcome
Title Physician Global Assessment of Disease Activity at Each Time Point
Hide Description The global assessment of the participant’s arthritis was assessed by the physician circling a number from 0 to 10 on a horizontal Likert scale ranging from “No Activity at All” (score = 0) to “Worst Activity Imaginable” (score = 10).
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Baseline (N=101, 102) 5.3  (1.7) 5.4  (1.6)
Week 2 (N=99, 106) 4.6  (1.9) 4.0  (1.8)
Week 4 (N=104, 106) 4.2  (1.9) 3.7  (1.9)
Week 8 (N=104, 106) 4.0  (2.0) 3.4  (2.1)
Week 12 (N=104, 106) 4.0  (2.1) 3.3  (2.1)
Week 16 (N=104, 106) 3.1  (2.0) 2.9  (2.0)
Week 20 (N=104, 106) 2.7  (1.7) 2.9  (2.1)
Week 24 (N=104, 106) 2.7  (1.8) 2.7  (1.9)
21.Secondary Outcome
Title Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) at Each Time Point
Hide Description The HAQ-DI asks about the degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and errands and chores). Responses in each functional area are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where zero represents no disability and three very severe, high-dependency disability.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Week 2 (N=98, 104) -0.093  (0.385) -0.266  (0.429)
Week 4 (N=103, 105) -0.164  (0.383) -0.315  (0.528)
Week 8 (N=99, 104) -0.208  (0.420) -0.370  (0.466)
Week 12 (N=101, 101) -0.203  (0.434) -0.388  (0.543)
Week 16 (N=98, 101) -0.347  (0.476) -0.403  (0.531)
Week 20 (N=95, 97) -0.412  (0.504) -0.423  (0.578)
Week 24 (N=91, 98) -0.445  (0.522) -0.475  (0.576)
22.Secondary Outcome
Title C-reactive Protein Levels at Each Time Point
Hide Description C-Reactive Protein (CRP) was measured from blood samples by a central laboratory as a marker for inflammation.
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; LOCF was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Mean (Standard Deviation)
Unit of Measure: mg/L
Baseline (N=104, 106) 9.44  (16.29) 7.56  (11.77)
Week 2 (N=100, 105) 8.68  (11.49) 3.97  (6.43)
Week 4 (N=104, 106) 9.75  (15.79) 4.60  (8.27)
Week 8 (N=104, 106) 8.03  (10.26) 3.94  (5.37)
Week 12 (N=104, 106) 8.33  (10.62) 4.09  (6.11)
Week 16 (N=104, 106) 5.17  (7.58) 3.76  (5.14)
Week 20 (N=104, 106) 4.75  (6.28) 3.75  (4.55)
Week 24 (N=104, 106) 5.75  (13.10) 4.40  (5.69)
23.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Physical Functioning Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The physical functioning subscale assesses limitations in physical activities because of health problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=100, 105) 45.16  (2.75) 45.71  (2.71)
Week 4 (N=101, 102) 47.54  (2.74) 51.86  (2.72)
Week 12 (N=99, 99) 53.02  (2.75) 52.06  (2.74)
Week 24 (N=88, 97) 60.38  (2.81) 55.63  (2.75)
24.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Vitality Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The vitality sub-score assesses energy and fatigue. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=101, 105) 42.65  (2.14) 41.11  (2.11)
Week 4 (N=103, 105) 46.45  (2.14) 49.27  (2.12)
Week 12 (N=100, 100) 47.55  (2.15) 48.90  (2.14)
Week 24 (N=90, 98) 53.03  (2.20) 54.08  (2.15)
25.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Role-Physical Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The role-physical subscale assesses limitations in usual role activities because of physical health problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 103) 49.34  (2.74) 51.69  (2.73)
Week 4 (N=102, 105) 56.09  (2.76) 58.09  (2.72)
Week 12 (N=100, 101) 57.74  (2.77) 57.83  (2.75)
Week 24 (N=89, 97) 65.87  (2.83) 59.54  (2.77)
26.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Bodily Pain Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning (less pain). Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 106) 41.98  (1.98) 38.39  (1.96)
Week 4 (N=103, 105) 47.77  (1.99) 52.17  (1.97)
Week 12 (N=101, 101) 51.15  (2.00) 52.79  (1.99)
Week 24 (N=88, 98) 61.66  (2.08) 59.42  (2.01)
27.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) General Health Perceptions Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 106) 49.13  (2.03) 51.77  (2.01)
Week 4 (N=103, 104) 52.52  (2.03) 56.31  (2.02)
Week 12 (N=100, 101) 52.21  (2.04) 54.77  (2.03)
Week 24 (N=89, 98) 55.94  (2.09) 57.44  (2.04)
28.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Social Functioning Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better level of functioning. The social functioning subscale assesses limitations in social activities because of physical or emotional problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 106) 65.14  (2.61) 63.21  (2.58)
Week 4 (N=103, 105) 69.04  (2.61) 72.03  (2.59)
Week 12 (N=101, 101) 69.68  (12.62) 69.32  (2.61)
Week 24 (N=88, 98) 78.59  (2.70) 75.19  (2.63)
29.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Role-Emotional Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The role-emotional subscale assesses limitations in usual role activities because of emotional problems. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 104) 69.23  (2.75) 66.36  (2.74)
Week 4 (N=102, 105) 71.92  (2.77) 72.56  (2.73)
Week 12 (N=100, 100) 75.86  (2.78) 71.87  (2.77)
Week 24 (N=89, 98) 80.12  (2.86) 76.30  (2.78)
30.Secondary Outcome
Title Short Form 36 Health Survey (SF-36) Mental Health Domain Score at Each Time Point
Hide Description The SF-36 measures the impact of disease on overall quality of life and consists of 36 questions in eight domains (physical function, pain, general and mental health, vitality, social function, physical and emotional health). The individual domain scores are calculated and transformed to range from 0 to 100, with higher scores indicating a better quality of life. The mental health sub-score assesses general mental health (psychological distress and well-being). Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 104) 70.14  (1.90) 66.56  (1.88)
Week 4 (N=103, 102) 69.74  (1.90) 72.01  (1.90)
Week 12 (N=100, 100) 72.05  (1.92) 72.56  (1.90)
Week 24 (N=89, 97) 75.71  (1.96) 74.20  (1.92)
31.Secondary Outcome
Title Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Work Time Missed (Absenteeism) at Each Time Point
Hide Description This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent of work time missed is derived from the number of hours of work missed due to rheumatoid arthritis symptoms as a percentage of total hours that should have been worked. A higher percentage indicates more hours missed. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants employed and included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: percent work time missed
Baseline (N=46, 46) 3.54  (2.04) 5.88  (2.03)
Week 4 (N=46, 42) 4.18  (2.03) 4.50  (2.12)
Week 12 (N=45, 40) 8.07  (2.06) 4.46  (2.16)
Week 24 (N=38, 43) 5.22  (2.21) 3.77  (2.09)
32.Secondary Outcome
Title Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Impairment While Working (Presenteeism) at Each Time Point
Hide Description This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent impairment while working was derived from the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants employed and included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: percent impairment while working
Baseline (N=45, 45) 34.39  (3.39) 36.86  (3.39)
Week 4 (N=44, 43) 31.91  (3.41) 25.04  (3.44)
Week 12 (N=39, 40) 25.49  (3.52) 24.61  (3.50)
Week 24 (N=37, 40) 21.46  (3.57) 21.10  (3.49)
33.Secondary Outcome
Title Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Activity Impairment at Each Time Point
Hide Description This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis. Percent activity impairment is derived from the patient’s assessment of the degree to which rheumatoid arthritis affected their regular daily activities. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: percent activity impairment
Baseline (N=103, 106) 49.29  (2.56) 50.38  (2.53)
Week 4 (N=102, 104) 41.22  (2.57) 38.67  (2.55)
Week 12 (N=99, 99) 39.16  (2.59) 35.98  (2.58)
Week 24 (N=88, 96) 29.91  (2.68) 30.57  (2.61)
34.Secondary Outcome
Title Work Productivity and Activity Impairment Questionnaire (WPAI): Percent Overall Work Impairment at Each Time Point
Hide Description This self-administered questionnaire is designed to address impairment to the work productivity and activity of participants due to rheumatoid arthritis in the past 7 days. Percent overall work impairment takes into account both hours missed due to rheumatoid arthritis symptoms and the participant’s assessment of the degree to which rheumatoid arthritis affected their productivity while working. A higher percentage indicates greater impairment and less productivity. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants employed and included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: percent overall work impairment
Baseline (N=45, 46) 34.79  (3.80) 36.71  (3.76)
Week 4 (N=46, 42) 33.14  (3.77) 26.14  (3.87)
Week 12 (N=45, 40) 27.23  (3.80) 26.22  (3.92)
Week 24 (N=38, 42) 23.93  (3.98) 22.58  (3.86)
35.Secondary Outcome
Title Participant Assessment of Fatigue at Each Time Point
Hide Description The participant's assessment of fatigue was collected using a single-item 100 mm visual analogue scale. The participant was asked to draw a vertical line through a horizontal line to indicate the degree of fatigue they experienced because of their condition over the past week. The horizontal line is 100 mm in length with ‘0’ and ‘no fatigue’ on the left end of the line and ‘100’ and ‘extreme fatigue’ on the right end of the line. Least squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=103, 105) 49.38  (2.63) 50.05  (2.61)
Week 2 (N=99, 104) 50.31  (2.66) 38.68  (2.61)
Week 4 (N=103, 105) 46.48  (2.63) 40.04  (2.61)
Week 8 (N=99, 104) 44.09  (2.66) 39.32  (2.62)
Week 12 (N=100, 100) 45.51  (2.66) 41.43  (2.64)
Week 16 (N=98, 101) 38.73  (2.67) 35.15  (2.64)
Week 20 (N=95, 97) 29.82  (2.69) 35.20  (2.66)
Week 24 (N=90, 98) 34.35  (2.72) 33.87  (2.65)
36.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Disturbance Scale at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). Sleep Disturbance measures the ability to fall asleep and to maintain restful sleep. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=102, 104) 45.02  (1.00) 44.95  (1.00)
Week 4 (N=103, 104) 46.42  (1.00) 46.38  (1.00)
Week 12 (N=98, 100) 46.10  (1.01) 46.91  (1.00)
Week 24 (N=86, 96) 48.23  (1.04) 47.38  (1.01)
37.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Shortness of Breath or Headache Scale at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=104, 106) 51.63  (0.95) 49.25  (0.94)
Week 4 (N=103, 104) 51.38  (0.95) 50.20  (0.95)
Week 12 (N=99, 98) 50.34  (0.97) 49.77  (0.97)
Week 24 (N=89, 97) 51.21  (1.00) 50.31  (0.97)
38.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Snoring Scale at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Shortness of Breath (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=101, 103) 47.78  (0.95) 47.13  (0.94)
Week 4 (N=102, 102) 49.14  (0.94) 47.91  (0.94)
Week 12 (N=99, 97) 49.47  (0.95) 49.04  (0.95)
Week 24 (N=86, 93) 49.95  (0.98) 48.25  (0.96)
39.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Adequacy Scale at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Sleep Adequacy measures sleep sufficiency in terms of whether the participant sleeps enough to provide restoration of wakefulness. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. For sleep adequacy a higher score indicates better sleep quality. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=102, 105) 47.12  (0.98) 46.72  (0.97)
Week 4 (N=103, 104) 47.63  (0.98) 47.42  (0.97)
Week 12 (N=99, 99) 46.86  (0.99) 47.73  (0.98)
Week 24 (N=87, 97) 48.73  (1.02) 48.66  (0.99)
40.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Daytime Somnolence Scale at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). Daytime somnolence measures drowsiness or sleepiness during the day. In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=103, 106) 46.82  (1.01) 46.27  (1.00)
Week 4 (N=103, 104) 46.62  (1.01) 48.72  (1.01)
Week 12 (N=99, 99) 47.80  (1.02) 48.05  (1.02)
Week 24 (N=87, 97) 48.31  (1.05) 48.80  (1.02)
41.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Problems Index I at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. The Sleep Problems Index-I is drawn from 6 items in the four domains including Sleep Disturbance (2 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (1 item). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=102, 105) 46.16  (0.92) 45.53  (0.91)
Week 4 (N=103, 104) 46.91  (0.92) 46.63  (0.91)
Week 12 (N=99, 97) 46.82  (0.92) 47.17  (0.92)
Week 24 (N=87, 97) 48.39  (0.95) 47.80  (0.92)
42.Secondary Outcome
Title Medical Outcomes Study (MOS) Sleep Problems Index II at Each Time Point
Hide Description The MOS-Sleep comprises 12 items and measures key sleep structures across 6 domains. These domains are Sleep Disturbance (4 items), Sleep Adequacy (2 items), Sleep Quantity (1 item), Daytime Somnolence (3 items), Snoring (1 item), and Awakening short of breath or with a headache, (1 item). The scale also produces two indices. Index-II uses 9 items from four domains including Sleep Disturbance (4 items), Sleep Adequacy (2 items), Shortness of Breath (1 item), and Daytime Somnolence (2 items). In MOS Sleep norm-based scoring, all scales are scored on the same metric, where 50 is the mean for the general U.S. population and 10 is the standard deviation. Higher scores indicate more severe sleep problems. Least Squares means are from a mixed-effect model for repeated measurements (MMRM).
Time Frame Baseline and Weeks 4, 12 and 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Primary analysis set; Mixed-Effect Model Repeated Measures (MMRM) analysis to account for post-baseline missing data with Likelihood-based approach was used. "N" indicates the number of participants included in the analyses at each time point.
Arm/Group Title Placebo Etanercept
Hide Arm/Group Description:
Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
Overall Number of Participants Analyzed 104 106
Least Squares Mean (Standard Error)
Unit of Measure: scores on a scale
Baseline (N=101, 104) 45.69  (0.93) 45.16  (0.92)
Week 4 (N=103, 104) 46.63  (0.93) 48.84  (0.92)
Week 12 (N=98, 97) 46.51  (0.94) 47.06  (0.94)
Week 24 (N=86, 96) 48.55  (0.96) 47.88  (0.94)
Time Frame 28 weeks
Adverse Event Reporting Description The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency threshold in either treatment group.
 
Arm/Group Title Placebo-Etanercept Etanercept-Etanercept
Hide Arm/Group Description Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period. Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
All-Cause Mortality
Placebo-Etanercept Etanercept-Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo-Etanercept Etanercept-Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   3/104 (2.88%)   4/106 (3.77%) 
Blood and lymphatic system disorders     
Anaemia  1  1/104 (0.96%)  1/106 (0.94%) 
Cardiac disorders     
Coronary artery disease  1  1/104 (0.96%)  0/106 (0.00%) 
Supraventricular tachycardia  1  0/104 (0.00%)  1/106 (0.94%) 
Gastrointestinal disorders     
Diverticular perforation  1  1/104 (0.96%)  0/106 (0.00%) 
Hepatobiliary disorders     
Cholelithiasis  1  1/104 (0.96%)  0/106 (0.00%) 
Infections and infestations     
Bronchitis  1  0/104 (0.00%)  1/106 (0.94%) 
Injury, poisoning and procedural complications     
Femur fracture  1  1/104 (0.96%)  0/106 (0.00%) 
Investigations     
Alanine aminotransferase increased  1  1/104 (0.96%)  0/106 (0.00%) 
Aspartate aminotransferase increased  1  1/104 (0.96%)  0/106 (0.00%) 
Nervous system disorders     
Transient ischaemic attack  1  0/104 (0.00%)  1/106 (0.94%) 
Reproductive system and breast disorders     
Menorrhagia  1  0/104 (0.00%)  1/106 (0.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo-Etanercept Etanercept-Etanercept
Affected / at Risk (%) Affected / at Risk (%)
Total   61/104 (58.65%)   62/106 (58.49%) 
Gastrointestinal disorders     
Nausea  1  6/104 (5.77%)  5/106 (4.72%) 
General disorders     
Fatigue  1  4/104 (3.85%)  6/106 (5.66%) 
Injection site erythema  1  11/104 (10.58%)  13/106 (12.26%) 
Injection site pain  1  6/104 (5.77%)  5/106 (4.72%) 
Injection site pruritus  1  8/104 (7.69%)  7/106 (6.60%) 
Injection site rash  1  6/104 (5.77%)  9/106 (8.49%) 
Infections and infestations     
Bronchitis  1  4/104 (3.85%)  7/106 (6.60%) 
Nasopharyngitis  1  12/104 (11.54%)  6/106 (5.66%) 
Sinusitis  1  7/104 (6.73%)  8/106 (7.55%) 
Upper respiratory tract infection  1  13/104 (12.50%)  8/106 (7.55%) 
Urinary tract infection  1  4/104 (3.85%)  7/106 (6.60%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  5/104 (4.81%)  6/106 (5.66%) 
Back pain  1  7/104 (6.73%)  5/106 (4.72%) 
Pain in extremity  1  1/104 (0.96%)  6/106 (5.66%) 
Rheumatoid arthritis  1  12/104 (11.54%)  12/106 (11.32%) 
Nervous system disorders     
Headache  1  16/104 (15.38%)  9/106 (8.49%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/104 (2.88%)  6/106 (5.66%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
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 Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. 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 multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01313208     History of Changes
Other Study ID Numbers: 20070561
First Submitted: March 10, 2011
First Posted: March 11, 2011
Results First Submitted: May 7, 2014
Results First Posted: June 17, 2014
Last Update Posted: February 9, 2017