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The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis

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ClinicalTrials.gov Identifier: NCT01001208
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : August 12, 2013
Last Update Posted : August 12, 2013
Sponsor:
Collaborator:
Immunex Corporation
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 Psoriasis
Interventions Drug: Methotrexate
Drug: Etanercept
Drug: Placebo
Enrollment 478
Recruitment Details Participants were enrolled from 09 November 2009 through 25 June 2010
Pre-assignment Details  
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Period Title: Overall Study
Started 239 239
Completed 211 206
Not Completed 28 33
Reason Not Completed
Adverse Event             10             5
Lost to Follow-up             5             9
Physician Decision             1             0
Withdrawal by Subject             4             5
Ineligibility Determined             4             2
Noncompliance             4             7
Disease Progression             0             3
Other             0             2
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo Total
Hide Arm/Group Description Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen. Total of all reporting groups
Overall Number of Baseline Participants 239 239 478
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants 239 participants 478 participants
42.99  (13.06) 45.23  (12.79) 44.11  (12.96)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
Female
86
  36.0%
72
  30.1%
158
  33.1%
Male
153
  64.0%
167
  69.9%
320
  66.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
American Indian or Alaska Native 1 0 1
Asian 10 9 19
Native Hawaiian or Other Pacific Islander 2 1 3
Black or African American 4 10 14
White 179 177 356
Hispanic or Latino 42 39 81
Japanese 0 0 0
Other 1 3 4
Aborigine 0 0 0
Psoriasis Area and Severity Index (PASI) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 239 participants 239 participants 478 participants
18.24  (8.15) 18.34  (6.62) 18.29  (7.42)
[1]
Measure Description: Psoriasis Area and Severity Index (PASI) Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by physicians using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Percent of Body Surface Area (BSA) Involved in Psoriasis  
Mean (Standard Deviation)
Unit of measure:  Percentage of BSA
Number Analyzed 239 participants 239 participants 478 participants
24.43  (15.94) 24.23  (13.64) 24.33  (14.82)
Body Mass Index Group  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
<=35 kg/m^2 172 173 345
>35 kg/m^2 67 66 133
Prior Anti-tumor Necrosis Factor (TNF) Exposure  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
Yes 42 48 90
No 197 191 388
1.Primary Outcome
Title PASI 75 Response at Week 24
Hide Description Percentage of participants achieving at least a 75% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame Baseline and 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
77.3 60.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
2.Secondary Outcome
Title PASI 50 Response at Week 24
Hide Description Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame Baseline and 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
91.6 84.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
3.Secondary Outcome
Title Static Physician Global Assessment (sPGA) Response at Week 24
Hide Description Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 24. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Time Frame Week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
71.8 54.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
4.Secondary Outcome
Title PASI 50 Response at Week 12
Hide Description Percentage of participants achieving at least a 50% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame Baseline and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
92.4 83.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
5.Secondary Outcome
Title PASI 75 Response at Week 12
Hide Description Percentage of participants achieving at least a 75% decrease (i.e. improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame Baseline and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
70.2 54.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
6.Secondary Outcome
Title Static Physician Global Assessment (sPGA) Response at Week 12
Hide Description Percentage of participants achieving a clear (0) or almost clear (1) status on the Static Physician Global Assessment (sPGA) at Week 12. This index evaluates the physician’s global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The assessment was scored by a blinded assessor on a scale of 0 to 5, where 0 = clear, with no evidence of plaque elevation, erythema, or scale, and 5 = severe induration, erythema, and scaling.
Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
65.5 47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
7.Secondary Outcome
Title PASI 90 Response at Week 12
Hide Description Percentage of participants achieving at least a 90% decrease (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 12. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame Baseline and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
34 23.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0348
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
8.Secondary Outcome
Title PASI 90 Response at Week 24
Hide Description Percentage of participants achieving at least a 90% decrese (improvement) from Baseline in the Psoriasis Area and Severity Index (PASI) at Week 24. PASI Score incorporates measures of erythema, desquamation, infiltration, and affected body surface area. Involvement and severity of psoriasis was scored by a blinded assessor using a scale of 0 to 72, where 0 = no psoriasis and 72 = severe disease.
Time Frame Baseline and 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Measure Type: Number
Unit of Measure: Percentage of participants
53.8 34.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0112
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method Cochran-Mantel-Haenszel
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
9.Secondary Outcome
Title Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12
Hide Description A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 12 score; a positive change from Baseline therefore indicates improvement.
Time Frame Baseline and 12 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Mean (Standard Deviation)
Unit of Measure: Percentage of BSA
16.3  (13.7) 15.2  (13.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1995
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method 2-sided van Elteren test
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
10.Secondary Outcome
Title Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24
Hide Description A measurement of psoriasis involvement, given as the physician’s assessment of the percentage of the participant’s total body surface area (BSA) involved with psoriasis. The BSA numerical score was completed by a blinded assessor. A decrease from Baseline indicates improvement. Change from Baseline was calculated as Baseline score - Week 24 score; a positive change from Baseline therefore indicates improvement.
Time Frame Baseline and 24 Weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
Arm/Group Title Etanercept + Methotrexate Etanercept + Placebo
Hide Arm/Group Description:
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
Overall Number of Participants Analyzed 238 234
Mean (Standard Deviation)
Unit of Measure: Percentage of BSA
19.5  (15.2) 17.8  (14.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Etanercept + Methotrexate, Etanercept + Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1995
Comments Overall significance level for primary and secondary endpoints controlled based on a combination of sequential testing and Hommel procedures.
Method 2-sided van Elteren test
Comments Stratified by baseline body mass index group and prior anti-TNF exposure group
Time Frame 52 weeks
Adverse Event Reporting Description The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
 
Arm/Group Title Etanercept + Placebo Etanercept + Methotrexate
Hide Arm/Group Description Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen. Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
All-Cause Mortality
Etanercept + Placebo Etanercept + Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Etanercept + Placebo Etanercept + Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   3/239 (1.26%)   2/239 (0.84%) 
Cardiac disorders     
Myocardial Infarction  1  1/239 (0.42%)  0/239 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  1/239 (0.42%)  0/239 (0.00%) 
Infections and infestations     
Pneumonia Bacterial  1  0/239 (0.00%)  1/239 (0.42%) 
Musculoskeletal and connective tissue disorders     
Lumbar Spinal Stenosis  1  0/239 (0.00%)  1/239 (0.42%) 
Synovial Cyst  1  0/239 (0.00%)  1/239 (0.42%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/239 (0.42%)  0/239 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Etanercept + Placebo Etanercept + Methotrexate
Affected / at Risk (%) Affected / at Risk (%)
Total   58/239 (24.27%)   67/239 (28.03%) 
Gastrointestinal disorders     
Nausea  1  7/239 (2.93%)  13/239 (5.44%) 
Infections and infestations     
Nasopharyngitis  1  26/239 (10.88%)  23/239 (9.62%) 
Upper Respiratory Tract Infection  1  12/239 (5.02%)  20/239 (8.37%) 
Nervous system disorders     
Headache  1  22/239 (9.21%)  22/239 (9.21%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
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 resul
Results Point of Contact
Name/Title: Study Director
Organization: Amgen Inc.
Phone: 866-572-6436
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01001208     History of Changes
Other Study ID Numbers: 20070559
First Submitted: October 15, 2009
First Posted: October 26, 2009
Results First Submitted: December 21, 2011
Results First Posted: August 12, 2013
Last Update Posted: August 12, 2013