Trial Outcomes & Findings for The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis (NCT NCT01001208)
NCT ID: NCT01001208
Last Updated: 2013-08-12
Results Overview
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.
COMPLETED
PHASE3
478 participants
Baseline and 24 Weeks
2013-08-12
Participant Flow
Participants were enrolled from 09 November 2009 through 25 June 2010
Participant milestones
| Measure |
Etanercept + Methotrexate
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.
|
Etanercept + Placebo
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 Study
STARTED
|
239
|
239
|
|
Overall Study
COMPLETED
|
211
|
206
|
|
Overall Study
NOT COMPLETED
|
28
|
33
|
Reasons for withdrawal
| Measure |
Etanercept + Methotrexate
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.
|
Etanercept + Placebo
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 Study
Adverse Event
|
10
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
9
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
5
|
|
Overall Study
Ineligibility Determined
|
4
|
2
|
|
Overall Study
Noncompliance
|
4
|
7
|
|
Overall Study
Disease Progression
|
0
|
3
|
|
Overall Study
Other
|
0
|
2
|
Baseline Characteristics
The Efficacy and Safety of Adding Methotrexate to Etanercept in Psoriasis
Baseline characteristics by cohort
| Measure |
Etanercept + Methotrexate
n=239 Participants
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.
|
Etanercept + Placebo
n=239 Participants
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
n=478 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42.99 years
STANDARD_DEVIATION 13.06 • n=5 Participants
|
45.23 years
STANDARD_DEVIATION 12.79 • n=7 Participants
|
44.11 years
STANDARD_DEVIATION 12.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
153 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 participants
n=5 Participants
|
10 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
179 participants
n=5 Participants
|
177 participants
n=7 Participants
|
356 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
42 participants
n=5 Participants
|
39 participants
n=7 Participants
|
81 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aborigine
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Psoriasis Area and Severity Index (PASI) Score
|
18.24 Units on a scale
STANDARD_DEVIATION 8.15 • n=5 Participants
|
18.34 Units on a scale
STANDARD_DEVIATION 6.62 • n=7 Participants
|
18.29 Units on a scale
STANDARD_DEVIATION 7.42 • n=5 Participants
|
|
Percent of Body Surface Area (BSA) Involved in Psoriasis
|
24.43 Percentage of BSA
STANDARD_DEVIATION 15.94 • n=5 Participants
|
24.23 Percentage of BSA
STANDARD_DEVIATION 13.64 • n=7 Participants
|
24.33 Percentage of BSA
STANDARD_DEVIATION 14.82 • n=5 Participants
|
|
Body Mass Index Group
<=35 kg/m^2
|
172 participants
n=5 Participants
|
173 participants
n=7 Participants
|
345 participants
n=5 Participants
|
|
Body Mass Index Group
>35 kg/m^2
|
67 participants
n=5 Participants
|
66 participants
n=7 Participants
|
133 participants
n=5 Participants
|
|
Prior Anti-tumor Necrosis Factor (TNF) Exposure
Yes
|
42 participants
n=5 Participants
|
48 participants
n=7 Participants
|
90 participants
n=5 Participants
|
|
Prior Anti-tumor Necrosis Factor (TNF) Exposure
No
|
197 participants
n=5 Participants
|
191 participants
n=7 Participants
|
388 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
PASI 75 Response at Week 24
|
77.3 Percentage of participants
|
60.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
PASI 50 Response at Week 24
|
91.6 Percentage of participants
|
84.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 24Population: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
Static Physician Global Assessment (sPGA) Response at Week 24
|
71.8 Percentage of participants
|
54.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
PASI 50 Response at Week 12
|
92.4 Percentage of participants
|
83.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
PASI 75 Response at Week 12
|
70.2 Percentage of participants
|
54.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
Static Physician Global Assessment (sPGA) Response at Week 12
|
65.5 Percentage of participants
|
47 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
PASI 90 Response at Week 12
|
34 Percentage of participants
|
23.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
PASI 90 Response at Week 24
|
53.8 Percentage of participants
|
34.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
Change From Baseline in the Percentage of Body Surface Area Involved With Psoriasis at Week 12
|
16.3 Percentage of BSA
Standard Deviation 13.7
|
15.2 Percentage of BSA
Standard Deviation 13.4
|
SECONDARY outcome
Timeframe: Baseline and 24 WeeksPopulation: Intention-to-Treat with available data; last observation carried forward (LOCF) imputation was used.
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.
Outcome measures
| Measure |
Etanercept + Methotrexate
n=238 Participants
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.
|
Etanercept + Placebo
n=234 Participants
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.
|
|---|---|---|
|
Change Form Baseline in Percentage of Body Surface Area Involved With Psoriasis at Week 24
|
19.5 Percentage of BSA
Standard Deviation 15.2
|
17.8 Percentage of BSA
Standard Deviation 14.0
|
Adverse Events
Etanercept + Placebo
Etanercept + Methotrexate
Serious adverse events
| Measure |
Etanercept + Placebo
n=239 participants at risk
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.
|
Etanercept + Methotrexate
n=239 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
0.42%
1/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.42%
1/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.42%
1/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.00%
0/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.42%
1/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Musculoskeletal and connective tissue disorders
Synovial Cyst
|
0.00%
0/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.42%
1/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.42%
1/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
0.00%
0/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Other adverse events
| Measure |
Etanercept + Placebo
n=239 participants at risk
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.
|
Etanercept + Methotrexate
n=239 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.9%
7/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
5.4%
13/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
26/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.6%
23/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.0%
12/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
8.4%
20/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
|
Nervous system disorders
Headache
|
9.2%
22/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
9.2%
22/239 • 52 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
|
Additional Information
Study Director
Amgen Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial resul
- Publication restrictions are in place
Restriction type: OTHER