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Clinical Trial Results:
A Multicenter Double-blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

Summary
EudraCT number	2014-004869-24
Trial protocol	LV GR GB PT HU CZ BG PL ES FR
Global end of trial date	06 Jul 2018

Results information
Results version number	v1(current)
This version publication date	15 Jul 2019
First version publication date	15 Jul 2019
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

20130207

ISRCTN number

US NCT number

NCT02376790

WHO universal trial number (UTN)

Sponsor organisation name

Amgen Inc.

Sponsor organisation address

One Amgen Center Drive, Thousand Oaks, United States, 91320

Public contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com

Scientific contact

IHQ Medical Info-Clinical Trials, Amgen (EUROPE) GmbH, MedInfoInternational@amgen.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

06 Jul 2018

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

06 Jul 2018

Was the trial ended prematurely?

Main objective of the trial

To evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy, in subjects with psoriatic arthritis (PsA) as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 24.

Protection of trial subjects

This study was conducted in accordance with International Council for Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. A copy of the protocol, proposed informed consent form, other written subject information, and any proposed advertising material were submitted to the institutional IRB/IEC for written approval. A copy of the written approval of the protocol and informed consent form were received by Amgen before subjects were recruited into the study and before shipment of Amgen investigational product. The investigator or his/her designee informed the subject of all aspects pertaining to the subject’s participation in the study before any screening procedures were performed.

Background therapy

Evidence for comparator

Actual start date of recruitment

03 Mar 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Bulgaria: 45

Country: Number of subjects enrolled

Argentina: 10

Country: Number of subjects enrolled

Canada: 25

Country: Number of subjects enrolled

Chile: 53

Country: Number of subjects enrolled

Czech Republic: 32

Country: Number of subjects enrolled

France: 1

Country: Number of subjects enrolled

Greece: 18

Country: Number of subjects enrolled

Hungary: 31

Country: Number of subjects enrolled

Latvia: 12

Country: Number of subjects enrolled

Mexico: 73

Country: Number of subjects enrolled

Poland: 61

Country: Number of subjects enrolled

Portugal: 16

Country: Number of subjects enrolled

Russian Federation: 77

Country: Number of subjects enrolled

South Africa: 32

Country: Number of subjects enrolled

Spain: 9

Country: Number of subjects enrolled

United Kingdom: 9

Country: Number of subjects enrolled

United States: 347

Worldwide total number of subjects

851

EEA total number of subjects

234

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

754

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study was conducted at 124 centers in Europe, Latin America, North America, and South Africa. Participants were enrolled from 03 March 2015 to 07 July 2017.

Screening details

The study consisted of a 30-day screening period, a 48-week randomized double blind treatment period, and a 30-day safety follow-up period. Participants were randomly assigned in a 1:1:1 ratio to 1 of 3 treatment groups.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Assessor

Are arms mutually exclusive

Yes

Methotrexate Monotherapy

Arm description

Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.

Arm type

Active comparator

Investigational medicinal product name

Placebo to Etanercept

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo to etanercept was administered by subcutaneous injection once a week.

Investigational medicinal product name

Methotrexate

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.

Etanercept Monotherapy

Arm description

Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.

Arm type

Experimental

Investigational medicinal product name

Etanercept

Investigational medicinal product code

Other name

Enbrel

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Etanercept was administered by subcutaneous injection once a week.

Investigational medicinal product name

Placebo to Methotrexate

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Placebo to methotrexate capsules taken orally once a week.

Etanercept + Methotrexate

Arm description

Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.

Arm type

Experimental

Investigational medicinal product name

Methotrexate

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.

Investigational medicinal product name

Etanercept

Investigational medicinal product code

Other name

Enbrel

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Etanercept was administered by subcutaneous injection once a week.

Number of subjects in period 1	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Started	284	284	283
Received Treatment	282	284	282
Completed	224	237	230
Not completed	60	47	53
Consent withdrawn by subject	43	36	37
Decision by Sponsor	2	1	4
Lost to follow-up	15	10	12

Baseline characteristics

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Reporting group title

Methotrexate Monotherapy

Reporting group description

Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.

Reporting group title

Etanercept Monotherapy

Reporting group description

Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.

Reporting group title

Etanercept + Methotrexate

Reporting group description

Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.

Reporting group values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate	Total
Number of subjects	284	284	283	851
Age, Customized
Units: Subjects
≤ 65 years	257	251	259	767
> 65 years	27	33	24	84
Age Continuous
Units: years
arithmetic mean (standard deviation)	48.7 ± 13.1	48.5 ± 13.5	48.1 ± 12.7	-
Sex: Female, Male
Units: Subjects
Female	160	133	139	432
Male	124	151	144	419
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaska Native	11	11	8	30
Asian	3	1	1	5
Black (or African American)	4	0	3	7
Mixed Race	0	1	0	1
Native Hawaiian or Other Pacific Islander	1	1	0	2
Other	10	18	6	34
White	255	252	265	772
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	58	70	69	197
Not Hispanic or Latino	226	214	214	654
Unknown or Not Reported	0	0	0	0
Body Mass Index (BMI)
Units: Subjects
≤ 30 kg/m²	146	153	160	459
> 30 kg/m²	138	130	123	391
Missing	0	1	0	1
Prior Use of Non-biologic Disease Modifying Antirheumatic Drugs (DMARDs)
Units: Subjects
Yes	38	26	43	107
No	246	258	240	744
Duration of Psoriatic Arthritis Disease
Data are provided for participants with available data (N = 231, 222, 231)
Units: years
arithmetic mean (standard deviation)	3.64 ± 6.85	3.10 ± 5.96	2.96 ± 5.99	-
Swollen Joint Count
A total of 66 joints were scored for presence or absence of swelling. Data are provided for all participants with available data (N = 284, 283, 282).
Units: joints
arithmetic mean (standard deviation)	12.9 ± 9.9	11.5 ± 9.6	11.2 ± 9.1	-
Tender Joint Count
A total of 68 joints were scored for presence or absence of tenderness. Data are provided for all participants with available data (N = 284, 283, 282).
Units: joints
arithmetic mean (standard deviation)	20.9 ± 15.0	18.8 ± 14.5	20.0 ± 15.3	-
Physician Global Assessment of Disease Activity
Assessed by the physician on a 100 mm visual analog scale (VAS), where 0 mm = No activity at all and 100 mm = Worst activity imaginable. Data are provided for all participants with available data (N = 284, 284, 282).
Units: mm
arithmetic mean (standard deviation)	58.6 ± 19.4	58.3 ± 18.2	58.0 ± 17.8	-
Patient Global Assessment of Disease Activity
Assessed by the participant on a 100 mm VAS, where 0 mm = No arthritis activity at all and 100 mm = Worst arthritis activity imaginable. Data are provided for all participants with available data (N = 283, 284, 282).
Units: mm
arithmetic mean (standard deviation)	60.7 ± 22.5	62.9 ± 22.1	61.0 ± 20.8	-
Patient Global Assessment of Joint Pain
Participants assessed their joint pain on a 100 mm VAS, where 0 mm = No pain at all and 100 mm = Worst pain imaginable. Data are provided for all participants with available data (N = 283, 284, 282).
Units: mm
arithmetic mean (standard deviation)	56.1 ± 21.7	56.5 ± 22.3	55.7 ± 21.6	-
Disability Index of the Health Assessment Questionnaire (HAQ-DI)
The HAQ-DI is a patient-reported questionnaire consisting of 20 questions in 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task in the past week using the following responses: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores were summed and averaged to provide an overall score ranging from 0 (no disability) to 3 (very severe, high-dependency disability). Data are provided for all participants with available data (N = 283, 284, 282).
Units: units on a scale
arithmetic mean (standard deviation)	1.3 ± 0.6	1.1 ± 0.6	1.2 ± 0.6	-
C-reactive Protein (CRP) Concentration
C-reactive protein (CRP) is a protein found in blood. CRP levels rise in response to inflammation. Data are provided for all participants with available data (N = 284, 282, 283).
Units: mg/L
arithmetic mean (standard deviation)	10.52 ± 16.29	10.72 ± 15.59	8.70 ± 11.65	-
Psoriatic Arthritis Disease Activity Score (PASDAS)
PASDAS is a measure of disease activity derived from: • Physician and patient global assessment of disease activity (0-100 VAS) • 68 tender joint count • 66 swollen joint count • Short Form-36 Questionnaire (SF-36) physical component summary (score 0-100) • Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20) • Leeds enthesitis index (enthesitis assessed at 6 sites; total score 0-6) • CRP The composite score is a weighted index with higher scores indicating more severe disease. Data are provided for subjects with available data (N = 282, 279, 280).
Units: units on a scale
median (full range (min-max))	6.10 (2.2 to 9.1)	6.02 (2.5 to 10.2)	5.95 (3.0 to 9.4)	-
Clinical Disease Activity Index (CDAI)
The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the following items: - 28 tender joint count, - 28 swollen joint count, - Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 = lowest disease activity and 10 cm highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity. Data are provided for subjects with available data (N = 283, 283, 281).
Units: units on a scale
arithmetic mean (standard deviation)	30.51 ± 13.26	28.45 ± 12.89	28.55 ± 12.71	-
Simplified Disease Activity Index (SDAI)
The Simplified Disease Activity Index (SDAI) is a composite index that is calculated as the sum of the following items: - 28 tender joint count, - 28 swollen joint count, - Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 = lowest disease activity and 10 = highest; - Physician's Global Assessment of Disease Activity -measured on a 10 VAS, where 0 = lowest disease activity and 10 cm = highest. - CRP The SDAI score ranges from 0 to 86 with higher scores representing worse disease. Data are provided for subjects with available data (N = 283, 281, 281).
Units: units on a scale
arithmetic mean (standard deviation)	31.56 ± 13.52	29.52 ± 13.19	29.43 ± 12.90	-
Disease Activity Score 28 (DAS28)
The DAS28 measures the severity of disease at a specific time and is derived from the following variables: - 28 tender joint count - 28 swollen joint count - C-reactive protein (CRP) concentration - Patient's global assessment of disease activity, measured on a 100 mm VAS, where 0 = lowest disease activity and 100 = highest. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. Higher scores indicate higher disease activity. Data are provided for subjects with available data (N = 283, 281, 281).
Units: units on a scale
arithmetic mean (standard deviation)	4.93 ± 1.11	4.80 ± 1.13	4.75 ± 1.12	-
Medical Outcomes Health Survey Short Form 36 Item (SF-36) Version 2 Physical Component Summary Score
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains. Two summary component scores are calculated: mental component summary score (MCS) and physical component summary score (PCS). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Data are provided for participants with available data (N = 282, 284, 282).
Units: units on a scale
arithmetic mean (standard deviation)	35.587 ± 8.411	37.835 ± 8.381	37.353 ± 9.243	-
Medical Outcomes Health Survey Short Form 36 Item(SF-36) Version 2 Mental Component Summary Score
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains. Two summary component scores are calculated: mental component summary score (MCS) and physical component summary score (PCS). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning. Data are provided for participants with available data (N = 282, 284, 282)
Units: units on a scale
arithmetic mean (standard deviation)	45.174 ± 12.073	45.107 ± 12.496	46.256 ± 11.236	-
Leeds Dactylitis Index (LDI)
The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits (on a scale from 0-3). The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the LDI; higher LDI indicates worse dactylitis. Data are provided for subjects with available data (N = 284, 283, 282).
Units: units on a scale
arithmetic mean (standard deviation)	56.89 ± 174.56	50.07 ± 137.20	44.11 ± 143.17	-
Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
The SPARCC enthesitis index assesses enthesitis at 18 sites for palpitation with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity). Tenderness at each site is quantified on a dichotomous basis (0 = non-tender, 1 = tender). A higher count represents greater enthesitis burden. Data are provided for subjects with available data (N = 284, 283, 282).
Units: units on a scale
arithmetic mean (standard deviation)	3.9 ± 4.3	3.7 ± 4.3	4.1 ± 4.5	-
Percentage of Body Surface Area (BSA) Involved in Psoriasis
The physician’s assessment of the percentage of the participant’s total body surface area involved with psoriasis.
Units: percent body surface area
arithmetic mean (standard deviation)	12.68 ± 18.78	10.76 ± 14.66	10.74 ± 15.58	-
Static Physician Global Assessment (sPGA)
The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling) 1 = almost clear 2 = mild 3 = moderate 4 = marked 5 = severe Data are provided for subjects with available data (N = 281, 284, 283).
Units: units on a scale
arithmetic mean (standard deviation)	2.6 ± 1.1	2.6 ± 1.0	2.5 ± 1.0	-

End points

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Reporting group title

Methotrexate Monotherapy

Reporting group description

Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.

Reporting group title

Etanercept Monotherapy

Reporting group description

Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.

Reporting group title

Etanercept + Methotrexate

Reporting group description

Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

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End point title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

End point description

A positive ACR20 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 20% improvement in 68 tender joint count; • ≥ 20% improvement in 66 swollen joint count; and • ≥ 20% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein concentration. Participants with missing postbaseline data were counted as non-responders.

End point type

Primary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: percentage of participants
number (not applicable)	50.7	60.9	65.0

Analysis of ACR 20 at Week 24

Statistical analysis description

The primary hypothesis of this study is that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with psoriatic arthritis achieving ACR 20 response at week 24.

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority ^[1]

P-value

= 0.005 ^[2]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

13.9

Confidence interval

level

95%

sides

2-sided

lower limit

5.8

upper limit

Notes
[1] - Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.
[2] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors.

Analysis of ACR 20 at Week 24

Statistical analysis description

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority ^[3]

P-value

= 0.029 ^[4]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

9.2

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

17.3

Notes
[3] - Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.
[4] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors.

Secondary: Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24

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End point title

Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24

End point description

Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: - Tender joint count (0-68) ≤ 1 - Swollen joint count (0-66) ≤ 1 - Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3% - Patient global assessment of joint pain VAS (0-100) ≤ 15 - Patient global assessment of disease activity VAS (0-100) ≤ 20 - HAQ-DI (0-3) ≤ 0.5 - Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1 Participants with missing data were counted as non-responders.

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: percentage of participants
number (not applicable)	22.9	35.9	35.7

Analysis of MDA at Week 24

Statistical analysis description

The secondary hypothesis of this study was that etanercept plus methotrexate therapy and etanercept monotherapy are more efficacious than methotrexate monotherapy as measured by the percentage of participants with PsA achieving MDA response at week 24.

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority ^[5]

P-value

= 0.005 ^[6]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

12.2

Confidence interval

level

95%

sides

2-sided

lower limit

4.9

upper limit

19.6

Notes
[5] - Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.
[6] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors.

Analysis of MDA at Week 24

Statistical analysis description

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority ^[7]

P-value

= 0.005 ^[8]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

11.6

Confidence interval

level

95%

sides

2-sided

lower limit

4.2

upper limit

18.9

Notes
[7] - Adjusted p-value was obtained by applying a Bonferroni-based testing procedure for multiplicity adjustment to control the family-wise, two-sided type one error rate at 0.05.
[8] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors.

Secondary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time

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End point title

Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time

End point description

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: percentage of participants
number (not applicable)
Week 4 (N = 280, 280, 276)	25.0	44.3	46.4
Week 8 (N = 271, 274, 268)	46.5	60.2	60.8
Week 12 (N = 267, 267, 263)	46.8	65.5	70.3
Week 16 (N = 253, 256, 248)	58.5	69.5	71.8
Week 24 (N = 253, 256, 256)	56.9	67.6	71.9
Week 36 (N = 243, 248, 240)	66.3	77.0	74.2
Week 48 (N = 229, 237, 230)	70.7	83.1	80.4

No statistical analyses for this end point

Secondary: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time

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End point title

Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time

End point description

A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 50% improvement in 68 tender joint count; • ≥ 50% improvement in 66 swollen joint count; and • ≥ 50% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: percentage of participants
number (not applicable)
Week 4 (N = 281, 279, 276)	6.0	16.5	18.8
Week 8 (N = 272, 275, 269)	15.1	31.3	30.1
Week 12 (N = 267, 267, 263)	16.9	40.4	39.2
Week 16 (N = 253, 256, 251)	29.2	43.8	43.4
Week 24 (N = 252, 257, 256)	30.6	44.4	45.7
Week 36 (N = 244, 246, 241)	41.8	57.3	56.0
Week 48 (N = 229, 238, 231)	49.3	63.0	60.2

Analysis of ACR50 Response at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[9]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

14.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.4

upper limit

Notes
[9] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Analysis of ACR50 Response at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.006 ^[10]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

11.8

Confidence interval

level

95%

sides

2-sided

lower limit

3.4

upper limit

20.2

Notes
[10] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Secondary: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time

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End point title

Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time

End point description

A positive ACR70 response is defined if the following 3 criteria for improvement from baseline were met: • ≥ 70% improvement in 68 tender joint count; • ≥ 70% improvement in 66 swollen joint count; and • ≥ 70% improvement in at least 3 of the 5 following parameters: ◦ Patient's assessment of joint pain (measured on a 100 mm visual analog scale [VAS]); ◦ Patient's global assessment of disease activity (measured on a 100 mm VAS); ◦ Physician's global assessment of disease activity (measured on a 100 mm VAS); ◦ Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); ◦ C-reactive protein.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: percentage of participants
number (not applicable)
Week 4 (N = 281, 280, 276)	2.8	3.6	5.1
Week 8 (N = 272, 277, 269)	4.4	15.2	14.5
Week 12 (N = 267, 268, 264)	5.2	24.3	22.3
Week 16 (N = 252, 256, 251)	10.7	24.2	25.5
Week 24 (N = 253, 257, 256)	13.8	29.2	27.7
Week 36 (N = 245, 247, 242)	19.6	38.5	33.5
Week 48 (N = 230, 237, 232)	25.2	39.7	39.7

Analysis of ACR70 Response at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[11]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

13.4

Confidence interval

level

95%

sides

2-sided

lower limit

6.5

upper limit

20.4

Notes
[11] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Analysis of ACR70 Response at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[12]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

13.7

Confidence interval

level

95%

sides

2-sided

lower limit

6.7

upper limit

20.7

Notes
[12] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Secondary: Change From Baseline in Tender Joint Count Over Time

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End point title

Change From Baseline in Tender Joint Count Over Time

End point description

The tender joint count is an assessment of the pain and/or tenderness of 68 joints using a 0 to 1 point scale (0 = none, 1 = present). The total tender joint count is calculated by summing the number of joints with present tenderness.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: tender joints
arithmetic mean (standard error)
Week 4 (N = 280, 279, 277)	-5.7 ± 0.6	-6.4 ± 0.6	-7.4 ± 0.6
Week 8 (N = 271, 276, 269)	-7.8 ± 0.7	-8.9 ± 0.6	-9.4 ± 0.7
Week 12 (N = 266, 267, 264)	-9.7 ± 0.7	-9.8 ± 0.7	-10.8 ± 0.7
Week 16 (N = 253, 257, 251)	-10.0 ± 0.7	-10.9 ± 0.7	-11.9 ± 0.8
Week 24 (N = 253, 257, 257)	-10.8 ± 0.8	-10.9 ± 0.8	-11.0 ± 0.9
Week 36 (N = 245, 248, 243)	-13.5 ± 0.8	-12.7 ± 0.8	-12.9 ± 0.9
Week 48 (N = 230, 239, 232)	-14.5 ± 0.8	-13.9 ± 0.8	-12.9 ± 0.9

No statistical analyses for this end point

Secondary: Change From Baseline in Swollen Joint Count Over Time

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End point title

Change From Baseline in Swollen Joint Count Over Time

End point description

The swollen joint count is an assessment of the swelling of 66 joints using a 0 to 1 point scale (0 = none, 1 = present). The total swollen joint count is calculated by summing the number of joints with present swelling.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: swollen joints
arithmetic mean (standard error)
Week 4 (N = 280, 279, 277)	-4.1 ± 0.4	-4.8 ± 0.3	-4.7 ± 0.4
Week 8 (N = 271, 276, 269)	-5.4 ± 0.5	-6.2 ± 0.4	-6.5 ± 0.4
Week 12 (N = 266, 267, 264)	-6.6 ± 0.5	-6.8 ± 0.4	-7.2 ± 0.4
Week 16 (N = 253, 257, 251)	-7.0 ± 0.5	-7.3 ± 0.4	-7.8 ± 0.4
Week 24 (N = 253, 257, 257)	-7.0 ± 0.5	-7.6 ± 0.5	-7.7 ± 0.5
Week 36 (N = 245, 248, 243)	-9.2 ± 0.5	-9.0 ± 0.5	-8.4 ± 0.5
Week 48 (N = 230, 239, 232)	-9.6 ± 0.5	-9.2 ± 0.5	-8.7 ± 0.5

No statistical analyses for this end point

Secondary: Change From Baseline in Physician Global Assessment of Disease Activity Over Time

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End point title

Change From Baseline in Physician Global Assessment of Disease Activity Over Time

End point description

A global assessment of the participant’s arthritis assessed by the physician on a 100 mm visual analog scale (VAS) where 0 mm = No activity at all and 100 mm = Worst activity imaginable.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: mm
arithmetic mean (standard error)
Week 4 (N = 278, 278, 277)	-16.8 ± 1.2	-23.1 ± 1.2	-22.8 ± 1.3
Week 8 (N = 271, 277, 269)	-25.0 ± 1.4	-29.7 ± 1.4	-30.4 ± 1.4
Week 12 (N = 266, 267, 264)	-26.8 ± 1.6	-32.7 ± 1.6	-33.9 ± 1.3
Week 16 (N = 251, 257, 252)	-30.3 ± 1.7	-34.9 ± 1.5	-36.2 ± 1.4
Week 24 (N = 250, 257, 257)	-29.6 ± 1.8	-35.7 ± 1.7	-35.8 ± 1.6
Week 36 (N = 241, 246, 241)	-37.1 ± 1.7	-42.8 ± 1.5	-39.9 ± 1.5
Week 48 (N = 229, 239, 232)	-41.4 ± 1.5	-43.8 ± 1.4	-41.5 ± 1.6

No statistical analyses for this end point

Secondary: Change From Baseline in Patient Global Assessment of Disease Activity Over Time

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End point title

Change From Baseline in Patient Global Assessment of Disease Activity Over Time

End point description

A global assessment of the participant’s arthritis, assessed by the participant on a 100 mm VAS where 0 mm = No arthritis activity at all and 100 mm = Worst arthritis activity imaginable.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: mm
arithmetic mean (standard error)
Week 4 (N = 280, 281, 277)	-11.0 ± 1.5	-21.9 ± 1.6	-21.0 ± 1.5
Week 8 (N = 271, 277, 269)	-15.6 ± 1.6	-27.3 ± 1.6	-26.4 ± 1.6
Week 12 (N = 266, 268, 264)	-18.6 ± 1.6	-29.9 ± 1.7	-28.0 ± 1.7
Week 16 (N = 252, 257, 250)	-22.7 ± 1.7	-30.9 ± 1.7	-29.3 ± 1.7
Week 24 (N = 252, 258, 257)	-23.0 ± 1.8	-32.3 ± 1.7	-29.6 ± 1.8
Week 36 (N = 243, 248, 241)	-26.0 ± 1.8	-36.4 ± 1.8	-32.4 ± 1.8
Week 48 (N = 228, 238, 232)	-28.9 ± 1.9	-38.8 ± 1.7	-33.3 ± 1.9

No statistical analyses for this end point

Secondary: Change From Baseline in Patient Global Assessment of Joint Pain Over Time

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End point title

Change From Baseline in Patient Global Assessment of Joint Pain Over Time

End point description

A global assessment of the severity of the participant’s joint pain, assessed by the participant on a 100 mm VAS where 0 mm = No pain at all and 100 mm = Worst pain imaginable.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: mm
arithmetic mean (standard error)
Week 4 (N = 280, 281, 277)	-8.9 ± 1.4	-18.4 ± 1.5	-18.5 ± 1.6
Week 8 (N = 271, 277, 269)	-14.5 ± 1.5	-23.5 ± 1.5	-24.0 ± 1.5
Week 12 (N = 266, 268, 264)	-16.0 ± 1.6	-24.1 ± 1.7	-24.9 ± 1.6
Week 16 (N = 252, 257, 250)	-20.9 ± 1.7	-25.9 ± 1.7	-25.6 ± 1.7
Week 24 (N = 252, 258, 257)	-20.6 ± 1.7	-26.4 ± 1.7	-26.9 ± 1.7
Week 36 (N = 243, 248, 241)	-23.9 ± 1.7	-31.5 ± 1.7	-28.8 ± 1.8
Week 48 (N = 228, 238, 232)	-27.2 ± 1.8	-32.5 ± 1.7	-31.1 ± 1.8

No statistical analyses for this end point

Secondary: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time

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End point title

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time

End point description

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: units on a scale
arithmetic mean (standard error)
Week 4 (N = 280, 281, 277)	-0.188 ± 0.024	-0.266 ± 0.024	-0.306 ± 0.029
Week 8 (N = 271, 276, 269)	-0.277 ± 0.029	-0.365 ± 0.031	-0.403 ± 0.032
Week 12 (N = 266, 268, 264)	-0.310 ± 0.030	-0.404 ± 0.029	-0.450 ± 0.033
Week 16 (N = 252, 257, 250)	-0.378 ± 0.036	-0.454 ± 0.033	-0.483 ± 0.036
Week 24 (N = 252, 258, 257)	-0.412 ± 0.036	-0.444 ± 0.035	-0.468 ± 0.038
Week 36 (N = 243, 248, 241)	-0.452 ± 0.038	-0.496 ± 0.039	-0.548 ± 0.040
Week 48 (N = 228, 238, 232)	-0.526 ± 0.041	-0.557 ± 0.038	-0.554 ± 0.041

No statistical analyses for this end point

Secondary: Change From Baseline in C-reactive Protein Concentration Over Time

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End point title

Change From Baseline in C-reactive Protein Concentration Over Time

End point description

C-reactive protein (CRP) is a specific measure of inflammatory activity.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: mg/L
arithmetic mean (standard error)
Week 4 (N = 275, 265, 256)	-0.93 ± 0.93	-5.91 ± 1.01	-5.49 ± 0.74
Week 8 (N = 270, 265, 257)	-2.31 ± 0.90	-7.51 ± 0.94	-5.19 ± 0.88
Week 12 (N = 262, 255, 247)	-3.36 ± 0.84	-7.38 ± 0.99	-5.71 ± 0.82
Week 16 (N = 248, 246, 241)	-2.81 ± 0.82	-7.40 ± 1.03	-5.59 ± 0.85
Week 24 (N = 246, 249, 247)	-2.60 ± 0.91	-6.91 ± 1.15	-5.82 ± 0.70
Week 36 (N = 236, 234, 230)	-4.16 ± 0.96	-7.36 ± 1.13	-5.82 ± 0.80
Week 48 (N = 223, 226, 219)	-4.88 ± 1.03	-7.45 ± 1.10	-5.81 ± 0.95

No statistical analyses for this end point

Secondary: Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time

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End point title

Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time

End point description

Minimal Disease Activity (MDA) is a measure of low disease activity specific for psoriatic arthritis (PsA) that incorporates measures of joint and entheseal inflammation, skin disease, patient reported outcomes and functional disability to assess disease activity. Participants were classified as achieving MDA if they fulfilled 5 of the following 7 outcome measures: • Tender joint count (0-68) ≤ 1 • Swollen joint count (0-66) ≤ 1 • Body surface area (BSA) involvement with psoriasis (0% to 100%) ≤ 3% • Patient global assessment of joint pain VAS (0-100) ≤ 15 • Patient global assessment of disease activity VAS (0-100) ≤ 20 • HAQ-DI (0-3) ≤ 0.5 • Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index (18 sites assessed for enthesitis with an overall score of 0 - 16) ≤ 1

End point type

Secondary

End point timeframe

Weeks 4, 8, 12, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: percentage of participants
number (not applicable)
Week 4 (N = 281, 280, 278)	5.7	11.1	12.6
Week 8 (N = 271, 276, 270)	3.0	9.4	7.4
Week 12 (N = 267, 268, 265)	11.6	29.9	29.1
Week 24 (N = 253, 258, 258)	25.7	39.5	39.1
Week 36 (N = 244, 248, 242)	30.3	43.5	46.7
Week 48 (N = 229, 238, 233)	35.8	51.3	53.2

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time

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End point title

Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time

End point description

PASDAS is a measure of disease activity derived from the following variables: • Physician and patient global assessment of disease activity (assessed on a 0-100 VAS) • 68 tender joint count • 66 swollen joint count • Short Form-36 Questionnaire (SF-36) physical component summary (general health status on a scale from 0-100) • Tender dactylitis count (each digit assessed for tender dactylitis; total score 0-20) • Leeds enthesitis index (enthesitis assessed at 6 sites; total score of 0-6) • CRP level (mg/L) The composite score is a weighted index where higher scores indicate more severe disease.

End point type

Secondary

End point timeframe

Baseline and weeks 12, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: units on a scale
arithmetic mean (standard error)
Week 12 (N = 261, 263, 261)	-1.63 ± 0.08	-2.32 ± 0.09	-2.37 ± 0.09
Week 24 (N = 246, 250, 255)	-1.98 ± 0.10	-2.64 ± 0.10	-2.63 ± 0.11
Week 36 (N = 234, 238, 232)	-2.46 ± 0.10	-3.10 ± 0.10	-2.95 ± 0.11
Week 48 (N = 226, 232, 229)	-2.70 ± 0.10	-3.23 ± 0.09	-3.10 ± 0.11

Analysis of Change in PASDAS at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[13]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.62

Confidence interval

level

95%

sides

2-sided

lower limit

-0.91

upper limit

-0.34

Variability estimate

Standard error of the mean

Dispersion value

0.14

Notes
[13] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in PASDAS at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[14]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.63

Confidence interval

level

95%

sides

2-sided

lower limit

-0.92

upper limit

-0.34

Variability estimate

Standard error of the mean

Dispersion value

0.15

Notes
[14] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive

Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time

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End point title

Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time

End point description

The Clinical Disease Activity Index (CDAI) is a composite index that is calculated as the sum of the following items: - 28 tender joint count, - 28 swollen joint count, - Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest; - Physician's Global Assessment of Disease Activity -measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. The CDAI score ranges from 0-76 where lower scores indicate less disease activity.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: units on a scale
arithmetic mean (standard error)
Week 4 (N = 276, 277, 276)	-8.38 ± 0.62	-10.59 ± 0.61	-10.68 ± 0.60
Week 8 (N = 270, 276, 268)	-11.56 ± 0.73	-14.13 ± 0.66	-14.56 ± 0.65
Week 12 (N = 265, 266, 263)	-13.93 ± 0.74	-15.61 ± 0.75	-16.12 ± 0.71
Week 16 (N = 250, 256, 248)	-15.20 ± 0.80	-16.49 ± 0.70	-17.37 ± 0.76
Week 24 (N = 249, 257, 256)	-15.74 ± 0.85	-17.12 ± 0.78	-16.43 ± 0.85
Week 36 (N = 240, 246, 239)	-18.90 ± 0.76	-19.79 ± 0.76	-18.86 ± 0.79
Week 48 (N = 228, 238, 231)	-20.16 ± 0.80	-20.78 ± 0.75	-19.35 ± 0.83

Analysis of Change in CDAI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.59 ^[15]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.63

Confidence interval

level

95%

sides

2-sided

lower limit

-2.93

upper limit

1.68

Variability estimate

Standard error of the mean

Dispersion value

1.18

Notes
[15] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in CDAI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.26 ^[16]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-1.32

Confidence interval

level

95%

sides

2-sided

lower limit

-3.63

upper limit

0.99

Variability estimate

Standard error of the mean

Dispersion value

1.18

Notes
[16] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time

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End point title

Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time

End point description

The Simplified Disease Activity Index (SDAI) is a composite index that is calculated as the sum of the following items: - 28 tender joint count, - 28 swollen joint count, - Patient's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest; - Physician's Global Assessment of Disease Activity measured on a 10 cm VAS, where 0 cm = lowest disease activity and 10 cm = highest. - CRP The SDAI score ranges from 0 to 86 with higher scores representing worse disease.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: units on a scale
arithmetic mean (standard error)
Week 4 (N = 275, 273, 273)	-8.38 ± 0.62	-11.12 ± 0.62	-11.18 ± 0.61
Week 8 (N = 270, 272, 267)	-11.77 ± 0.72	-14.92 ± 0.69	-15.14 ± 0.66
Week 12 (N = 264, 264, 263)	-14.32 ± 0.75	-16.44 ± 0.77	-16.67 ± 0.73
Week 16 (N = 248, 253, 246)	-15.55 ± 0.81	-17.25 ± 0.72	-17.79 ± 0.78
Week 24 (N = 248, 253, 256)	-15.96 ± 0.86	-17.75 ± 0.81	-17.01 ± 0.87
Week 36 (N = 239, 242, 235)	-19.27 ± 0.77	-20.50 ± 0.78	-19.46 ± 0.82
Week 48 (N = 228, 234, 229)	-20.65 ± 0.81	-21.61 ± 0.77	-19.94 ± 0.87

Analysis of Change in SDAI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.41 ^[17]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.98

Confidence interval

level

95%

sides

2-sided

lower limit

-3.35

upper limit

1.38

Variability estimate

Standard error of the mean

Dispersion value

1.2

Notes
[17] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive

Analysis of Change in SDAI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.15 ^[18]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-1.72

Confidence interval

level

95%

sides

2-sided

lower limit

-4.09

upper limit

0.65

Variability estimate

Standard error of the mean

Dispersion value

1.21

Notes
[18] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time

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End point title

Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time

End point description

The DAS28 measures the severity of disease at a specific time and is derived from the following variables: - 28 tender joint count - 28 swollen joint count - C-reactive protein (CRP) - Patient's global assessment of disease activity, measured on a 100 mm VAS, where 0 mm = lowest disease activity and 100 mm = highest. DAS28(CRP) scores range from 0 to approximately 10, with the upper bound dependent on the highest possible level of CRP. A DAS28 score higher than 5.1 indicates high disease activity, a DAS28 score less than 3.2 indicates low disease activity, and a DAS28 score less than 2.6 indicates clinical remission.

End point type

Secondary

End point timeframe

Baseline and weeks 4, 8, 12, 16, 24, 36, and 48

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	284	284	283
Units: units on a scale
arithmetic mean (standard error)
Week 4 (N = 278, 275, 273)	-0.73 ± 0.05	-1.18 ± 0.06	-1.21 ± 0.06
Week 8 (N = 270, 272, 267)	-1.05 ± 0.06	-1.64 ± 0.07	-1.61 ± 0.07
Week 12 (N = 264, 265, 263)	-1.34 ± 0.06	-1.78 ± 0.08	-1.80 ± 0.08
Week 16 (N = 250, 253, 246)	-1.47 ± 0.07	-1.90 ± 0.08	-1.92 ± 0.08
Week 24 (N = 251, 253, 256)	-1.55 ± 0.08	-1.97 ± 0.08	-1.86 ± 0.08
Week 36 (N = 242, 244, 236)	-1.88 ± 0.07	-2.25 ± 0.08	-2.20 ± 0.09
Week 48 (N = 228, 234, 229)	-2.04 ± 0.07	-2.38 ± 0.08	-2.23 ± 0.09

Analysis of Change in DAS28 at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

567

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.01 ^[19]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.29

Confidence interval

level

95%

sides

2-sided

lower limit

-0.52

upper limit

-0.07

Variability estimate

Standard error of the mean

Dispersion value

0.11

Notes
[19] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in DAS28 at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

568

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[20]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.62

upper limit

-0.17

Variability estimate

Standard error of the mean

Dispersion value

0.12

Notes
[20] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24

Top of page

End point title

Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24

End point description

The Health Assessment Questionnaire - Disability Index is a patient-reported questionnaire consisting of 20 questions referring in 8 functional areas: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task are summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from Baseline in the overall score indicate improvement in functional ability.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	252	258	257
Units: units on a scale
arithmetic mean (standard error)	-0.412 ± 0.036	-0.444 ± 0.035	-0.468 ± 0.038

Analysis of Change in HAQ-DI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

509

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.34 ^[21]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.05

Confidence interval

level

95%

sides

2-sided

lower limit

-0.15

upper limit

0.05

Variability estimate

Standard error of the mean

Dispersion value

0.05

Notes
[21] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in HAQ-DI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

510

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.67 ^[22]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.02

Confidence interval

level

95%

sides

2-sided

lower limit

-0.12

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.05

Notes
[22] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24

Top of page

End point title

Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24

End point description

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains. Two summary component scores are calculated: mental component summary score (MCS) and physical component summary score (PCS). The MCS consists of social functioning, vitality, mental health, and role-emotional scales and the PCS consists of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	253	256	257
Units: units on a scale
arithmetic mean (standard error)
Physical Component Summary	5.952 ± 0.550	7.808 ± 0.546	8.011 ± 0.598
Mental Component Summary	3.259 ± 0.589	2.835 ± 0.624	3.321 ± 0.572

Analysis of Change in PCS at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

510

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.015 ^[23]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

1.94

Confidence interval

level

95%

sides

2-sided

lower limit

0.37

upper limit

3.51

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[23] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in PCS at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

509

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.033 ^[24]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

1.71

Confidence interval

level

95%

sides

2-sided

lower limit

0.13

upper limit

3.28

Variability estimate

Standard error of the mean

Dispersion value

0.8

Notes
[24] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in MCS at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

510

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.97 ^[25]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-1.69

upper limit

1.63

Variability estimate

Standard error of the mean

Dispersion value

0.84

Notes
[25] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in MCS at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

509

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.56 ^[26]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2.16

upper limit

1.16

Variability estimate

Standard error of the mean

Dispersion value

0.85

Notes
[26] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24

Top of page

End point title

Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24

End point description

The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features: • pitting (scores 0-3, depending on the number of pits) • nail plate crumbling (scores 0-3, depending on the % of nail involvement) • onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement) • leukonychia (0 = absent, 1 = present) • red spots in lunula (0 = absent, 1 = present) • nail bed hyperkeratosis (0 = absent, 1 = present) • splinter hemorrhages (0 = absent, 1 = present) In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, the fingernail with the highest mNAPSI score). This fingernail was followed for the remainder of the study. mNAPSI scores range from 0-13 where higher scores represent worse nail disease. The analysis includes participants with non-zero mNAPSI score at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	121	115	123
Units: units on a scale
arithmetic mean (standard error)	-1.1 ± 0.2	-1.5 ± 0.2	-1.7 ± 0.2

Analysis of Change in mNAPSI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

244

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.02 ^[27]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.56

Confidence interval

level

95%

sides

2-sided

lower limit

-1.03

upper limit

-0.09

Variability estimate

Standard error of the mean

Dispersion value

0.24

Notes
[27] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in mNAPSI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

236

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.1 ^[28]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

-0.4

Confidence interval

level

95%

sides

2-sided

lower limit

-0.88

upper limit

0.08

Variability estimate

Standard error of the mean

Dispersion value

0.24

Notes
[28] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Percentage of Participants With Clear mNAPSI at Week 24

Top of page

End point title

Percentage of Participants With Clear mNAPSI at Week 24

End point description

The modified NAPSI scale is a grading system for nail psoriasis that incorporates the following 7 clinical features: • pitting (scores 0-3, depending on the number of pits) • nail plate crumbling (scores 0-3, depending on the % of nail involvement) • onycholysis and oil drop dyschromia (scores 0-3, depending on the % of nail involvement) • leukonychia (0 = absent, 1 = present) • red spots in lunula (0 = absent, 1 = present) • nail bed hyperkeratosis (0 = absent, 1 = present) • splinter hemorrhages (0 = absent, 1 = present) In participants with fingernails involved with psoriasis, each fingernail was scored at baseline to determine the worst fingernail (ie, with the highest mNAPSI score). This fingernail was followed for the remainder of the study. mNAPSI scores range from 0-13 where higher scores represent worse nail disease. Clear mNAPSI is defined as a score = 0. The analysis includes participants with non-zero mNAPSI score at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	121	115	123
Units: percentage of participants
number (not applicable)	0.0	0.0	0.0

No statistical analyses for this end point

Secondary: Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24

Top of page

End point title

Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24

End point description

The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst]. The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. The analysis includes participants with non-zero LDI score at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	89	89	87
Units: units on a scale
arithmetic mean (standard error)	-128.80 ± 26.76	-119.09 ± 20.66	-110.15 ± 22.70

Analysis of Change in LDI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

176

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.68 ^[29]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

13.92

Confidence interval

level

95%

sides

2-sided

lower limit

-51.52

upper limit

79.36

Variability estimate

Standard error of the mean

Dispersion value

33.23

Notes
[29] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in LDI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.85 ^[30]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

6.34

Confidence interval

level

95%

sides

2-sided

lower limit

-58.75

upper limit

71.42

Variability estimate

Standard error of the mean

Dispersion value

33.05

Notes
[30] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Percentage of Participants With Clear LDI at Week 24

Top of page

End point title

Percentage of Participants With Clear LDI at Week 24

End point description

The Leeds dactylitis index quantitatively measures dactylitis using the circumference of involved digits and control digits and tenderness of involved digits. Digits affected by dactylitis are defined as those with a 10% difference in the ratio of circumference of the affected digit to the contralateral digit. The control digit is either the contralateral digit (digit on opposite hand or foot), or if the contralateral digit is also affected, values from a standard reference table. Tenderness of affected digits is assessed on a scale from 0 [none] to 3 [worst]. The ratio of circumference between an affected digit and the control digit is multiplied by the tenderness score for the affected digit. The results from each involved digit are summed to provide the final LDI. A higher LDI indicates worse dactylitis. Clear LDI is defined as a score = 0. The analysis includes participants with non-zero LDI score at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	89	89	87
Units: percentage of participants
number (not applicable)	65.2	76.4	79.3

Analysis of Clear LDI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

176

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.057 ^[31]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

12.9

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

26.2

Notes
[31] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Analysis of Clear LDI at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

178

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.12 ^[32]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

10.9

Confidence interval

level

95%

sides

2-sided

lower limit

-2.5

upper limit

24.4

Notes
[32] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24

Top of page

End point title

Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24

End point description

The SPARCC enthesitis index assesses enthesitis at 18 sites for palpitation with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site because of their anatomical proximity). Tenderness at each site is quantified on a dichotomous basis (0 = non-tender, 1 = tender). Entheses assessed are medial epicondyle (left and right), lateral epicondyle (left and right), supraspinatus insertion into greater tuberosity of humerus (left and right), greater trochanter (left and right), quadriceps insertion into superior border of patella (left and right), patellar ligament insertion into inferior pole of patella or tibial tubercle (left and right), Achilles tendon insertion into calcaneum (left and right), plantar fascia insertion into calcaneum (left and right). A higher count represents greater enthesitis burden. The analysis includes participants with non-zero SPARCC enthesitis index at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	167	173	179
Units: units on a scale
arithmetic mean (standard error)	-3.1 ± 0.3	-3.0 ± 0.3	-2.9 ± 0.3

Analysis of Change in SPARCC Enthesitis at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

346

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7 ^[33]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

0.16

Confidence interval

level

95%

sides

2-sided

lower limit

-0.66

upper limit

0.98

Variability estimate

Standard error of the mean

Dispersion value

0.42

Notes
[33] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in SPARCC Enthesitis at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

340

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.93 ^[34]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-0.79

upper limit

0.86

Variability estimate

Standard error of the mean

Dispersion value

0.42

Notes
[34] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24

Top of page

End point title

Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24

End point description

The SPARCC enthesitis index assesses enthesitis at 18 sites with a resultant total score of 0 to 16 (for scoring purposes, the inferior patella and tibial tuberosity are considered 1 site due to their anatomical proximity). Tenderness at each site is scored as either 0 (non-tender) or 1 (tender). Entheses assessed are medial epicondyle, lateral epicondyle, supraspinatus insertion into greater tuberosity of humerus, greater trochanter, quadriceps insertion into superior border of patella, patellar ligament insertion into inferior pole of patella or tibial tubercle, Achilles tendon insertion into calcaneum, plantar fascia insertion into calcaneum. A higher count represents greater enthesitis burden. Clear SPARCC enthesitis is defined as a score = 0. The analysis includes participants with non-zero SPARCC enthesitis index at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	167	173	179
Units: percentage of participants
number (not applicable)	43.1	52.6	47.8

Analysis of Clear SPARCC Enthesitis at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

346

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.55 ^[35]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

3.2

Confidence interval

level

95%

sides

2-sided

lower limit

-7.3

upper limit

13.7

Notes
[35] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Analysis of Clear SPARCC Enthesitis at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

340

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.11 ^[36]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

8.8

Confidence interval

level

95%

sides

2-sided

lower limit

-1.9

upper limit

19.4

Notes
[36] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Secondary: Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24

Top of page

End point title

Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24

End point description

The physician’s assessment of the percentage of the participant’s total body surface area involved with psoriasis. Percent improvement from baseline = (Baseline Value – Post-baseline Value) / Baseline * 100 The analysis includes participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available data at week 24.

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	179	166	163
Units: percent change
arithmetic mean (standard error)	66.12 ± 2.76	69.80 ± 2.73	75.53 ± 3.71

Analysis of Change in BSA Involvement at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

342

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.031 ^[37]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

9.36

Confidence interval

level

95%

sides

2-sided

lower limit

0.85

upper limit

17.87

Variability estimate

Standard error of the mean

Dispersion value

4.33

Notes
[37] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of Change in BSA Involvement at Week 24

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

345

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.49 ^[38]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

3.02

Confidence interval

level

95%

sides

2-sided

lower limit

-5.49

upper limit

11.54

Variability estimate

Standard error of the mean

Dispersion value

4.33

Notes
[38] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or >30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups

Top of page

End point title

Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups

End point description

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	254	259	259
Units: percent change
arithmetic mean (standard error)
< 3% BSA involvement (N = 75, 93, 96)	-24.49 ± 46.71	-92.18 ± 108.54	17.66 ± 51.97
≥ 3% to < 10% BSA involvement (N = 87, 75, 77)	66.61 ± 4.18	64.42 ± 4.43	68.76 ± 7.26
≥ 10% BSA involvement (N = 92, 91, 86)	65.66 ± 3.66	74.23 ± 3.32	81.61 ± 2.55

Analysis of BSA Improvement in BSA ≥ 10% Subgroup

Statistical analysis description

Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

513

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[39]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

15.95

Confidence interval

level

95%

sides

2-sided

lower limit

6.99

upper limit

24.9

Variability estimate

Standard error of the mean

Dispersion value

4.55

Notes
[39] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Analysis of BSA Improvement in BSA ≥ 10% Subgroup

Statistical analysis description

Analysis of percent improvement from baseline in the percentage of BSA involved in psoriasis in the subgroup of participants with ≥ 10% BSA involvement at baseline.

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

513

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.12 ^[40]

Method

ANCOVA

Parameter type

LS Mean Treatment Difference

Point estimate

6.97

Confidence interval

level

95%

sides

2-sided

lower limit

-1.89

upper limit

15.83

Variability estimate

Standard error of the mean

Dispersion value

4.5

Notes
[40] - ANCOVA model adjusted for baseline BMI status (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD use. P-value is unadjusted and considered descriptive.

Secondary: Static Physician Global Assessment (sPGA) at Week 24

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End point title

Static Physician Global Assessment (sPGA) at Week 24

End point description

The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling) 1 = almost clear (minimal plaque elevation, erythema or scaling) 2 = mild (mild plaque elevation or scaling, light red coloration) 3 = moderate (moderate plaque elevation, scaling, light red coloration) 4 = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration) 5 = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration). The analysis includes participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data at week 24.

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	178	166	161
Units: participants
0 (clear)	38	36	63
1 (almost clear)	80	84	62
2 (mild)	34	28	25
3 (moderate)	22	12	10
4 (marked)	3	6	1
5 (severe)	1	0	0

No statistical analyses for this end point

Secondary: Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups

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End point title

Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	253	258	257
Units: participants
< 3% BSA involvement at baseline: Total	75	92	96
< 3% BSA involvement: 0 (clear)	26	29	52
< 3% BSA involvement: 1 (almost clear)	28	37	32
< 3% BSA involvement: 2 (mild)	15	19	9
< 3% BSA involvement: 3 (moderate)	4	6	3
< 3% BSA involvement: 4 (marked)	2	1	0
< 3% BSA involvement: 5 (severe)	0	0	0
≥ 3% to < 10% BSA involvement at baseline: Total	87	75	76
≥ 3% to < 10% BSA involvement: 0 (clear)	23	16	35
≥ 3% to < 10% BSA involvement: 1 (almost clear)	41	32	23
≥ 3% to < 10% BSA involvement: 2 (mild)	13	18	12
≥ 3% to < 10% BSA involvement: 3 (moderate)	10	7	5
≥ 3% to < 10% BSA involvement: 4 (marked)	0	2	1
≥ 3% to < 10% BSA involvement: 5 (severe)	0	0	0
≥ 10% BSA involvement at baseline: Total	91	91	85
≥ 10% BSA involvement at baseline: 0 (clear)	15	20	28
≥ 10% BSA involvement: 1 (almost clear)	39	52	39
≥ 10% BSA involvement at baseline: 2 (mild)	21	10	13
≥ 10% BSA involvement at baseline: 3 (moderate)	12	5	5
≥ 10% BSA involvement at baseline: 4 (marked)	3	4	0
≥ 10% BSA involvement at baseline: 5 (severe)	1	0	0

No statistical analyses for this end point

Secondary: Mean Static Physician Global Assessment (sPGA) Score at Week 24

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End point title

Mean Static Physician Global Assessment (sPGA) Score at Week 24

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	178	166	161
Units: units on a scale
arithmetic mean (standard error)	1.3 ± 0.1	1.2 ± 0.1	0.9 ± 0.1

No statistical analyses for this end point

Secondary: Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups

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End point title

Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	253	258	257
Units: units on a scale
arithmetic mean (standard error)
< 3% BSA involvement (N = 75, 92, 96)	1.0 ± 0.1	1.1 ± 0.1	0.6 ± 0.1
≥ 3% to < 10% BSA involvement (N = 87, 75, 76)	1.1 ± 0.1	1.3 ± 0.1	0.9 ± 0.1
≥ 10% BSA involvement (N = 91, 91, 85)	1.5 ± 0.1	1.1 ± 0.1	0.9 ± 0.1

No statistical analyses for this end point

Secondary: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24

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End point title

Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24

End point description

The static Physician Global Assessment of psoriasis (sPGA) evaluates the physician’s global assessment of the participant’s psoriasis based on severity of induration, scaling, and erythema. The sPGA is assessed on a scale from 0 to 5: 0 = clear (no evidence of plaque elevation, erythema or scaling) 1 = almost clear (minimal plaque elevation, erythema or scaling) 2 = mild (mild plaque elevation or scaling, light red coloration) 3 = moderate (moderate plaque elevation, scaling, light red coloration) 4 = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration) 5 = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration). The analysis included participants with ≥ 3% body surface area (BSA) psoriasis involvement at baseline and available sPGA data at week 24.

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	178	166	161
Units: percentage of participants
number (not applicable)	66.3	72.3	77.6

Analysis of sPGA Clear or Almost Clear

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

339

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.019 ^[41]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

11.4

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

20.8

Notes
[41] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Analysis of sPGA Clear or Almost Clear

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

344

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.4 ^[42]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

4.2

Confidence interval

level

95%

sides

2-sided

lower limit

-5.6

upper limit

Notes
[42] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Secondary: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups

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End point title

Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups

End point description

End point type

Secondary

End point timeframe

Week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	253	258	257
Units: percentage of participants
number (not applicable)
< 3% BSA involvement (N = 75, 92, 96)	72.0	71.7	87.5
≥ 3% to < 10% BSA involvement (N = 87, 75, 76)	73.6	64.0	76.3
≥ 10% BSA involvement (N = 91, 91, 85)	59.3	79.1	78.8

Analysis of sPGA 0 or 1 in BSA ≥ 10% Subgroup

Statistical analysis description

Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.

Comparison groups

Methotrexate Monotherapy v Etanercept + Methotrexate

Number of subjects included in analysis

510

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004 ^[43]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

20.1

Confidence interval

level

95%

sides

2-sided

lower limit

6.8

upper limit

33.3

Notes
[43] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Analysis of sPGA 0 or 1 in BSA ≥ 10% Subgroup

Statistical analysis description

Analysis of percentage of participants with an sPGA of 0 or 1 at Week 24 in participants with baseline BSA involvement with psoriasis ≥ 10%.

Comparison groups

Methotrexate Monotherapy v Etanercept Monotherapy

Number of subjects included in analysis

511

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.012 ^[44]

Method

Cochran-Mantel-Haenszel

Parameter type

Treatment Difference

Point estimate

17.1

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

30.2

Notes
[44] - Cochran-Mantel-Haenszel test with baseline body mass index (≤ 30 kg/m² or > 30 kg/m²) and prior non-biologic DMARD treatment as stratification factors. P-value is unadjusted and considered descriptive.

Secondary: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24

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End point title

Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	177	166	161
Units: percentage of participants
number (not applicable)	29.9	28.9	18.0

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups

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End point title

Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups

End point description

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	250	258	257
Units: percentage of participants
number (not applicable)
< 3% BSA involvement (N = 73, 92, 96)	37.0	44.6	43.8
≥ 3% to < 10% BSA involvement (N = 86, 75, 76)	27.9	38.7	21.1
≥ 10% BSA involvement (N = 91, 91, 85)	31.9	20.9	15.3

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24

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End point title

Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24

End point description

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	177	166	161
Units: percentage of participants
number (not applicable)	30.5	28.9	35.4

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups

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End point title

Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups

End point description

End point type

Secondary

End point timeframe

Baseline and week 24

End point values	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Number of subjects analysed	250	258	257
Units: percentage of participants
number (not applicable)
< 3% BSA involvement (N = 73, 92, 96)	15.1	20.7	30.2
≥ 3% to < 10% BSA involvement (N = 86, 75, 76)	34.9	25.3	32.9
≥ 10% BSA involvement (N = 91, 91, 85)	26.4	31.9	37.6

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

48-week treatment period plus 30-day safety follow-up

Adverse event reporting additional description

Two participants randomized to the Etanercept Monotherapy arm also received methotrexate in error, so are counted in the Etanercept + Methotrexate group for safety.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

21.0

Reporting group title

Methotrexate Monotherapy

Reporting group description

Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.

Reporting group title

Etanercept Monotherapy

Reporting group description

Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.

Reporting group title

Etanercept + Methotrexate

Reporting group description

Participants received etanercept 50 mg a week by subcutaneous injection and oral methotrexate 20 mg a week for 48 weeks.

Serious adverse events	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Total subjects affected by serious adverse events
subjects affected / exposed	16 / 282 (5.67%)	19 / 282 (6.74%)	17 / 284 (5.99%)
number of deaths (all causes)	0	0	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage II
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malignant melanoma
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Non-Hodgkin's lymphoma
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Prostate cancer metastatic
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thyroid neoplasm
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Surgical and medical procedures
Spinal fusion surgery
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	2 / 284 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Suicide attempt
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	3 / 282 (1.06%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	3 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatic enzyme increased
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver function test abnormal
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Anaemia postoperative
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Foreign body
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	2 / 282 (0.71%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angina unstable
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac failure congestive
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiomyopathy
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Coronary artery disease
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Supraventricular tachyarrhythmia
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Migraine
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Neuropathy peripheral
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Radiculopathy
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 282 (0.00%)	2 / 282 (0.71%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Gastric ulcer
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastritis
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pancreatitis acute
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Cholecystitis acute
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Liver injury
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Psoriasis
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Nephrolithiasis
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthritis
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Spondylolisthesis
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vertebral foraminal stenosis
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Acute pulmonary histoplasmosis
subjects affected / exposed	1 / 282 (0.35%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	1 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Appendicitis
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	2 / 284 (0.70%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bronchitis
subjects affected / exposed	0 / 282 (0.00%)	2 / 282 (0.71%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	1 / 2	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 282 (0.00%)	2 / 282 (0.71%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 4	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Chronic sinusitis
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Escherichia urinary tract infection
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Influenza
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Necrotising fasciitis streptococcal
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonsillar abscess
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia bacterial
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia necrotising
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Post procedural sepsis
subjects affected / exposed	0 / 282 (0.00%)	0 / 282 (0.00%)	1 / 284 (0.35%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sinusitis
subjects affected / exposed	0 / 282 (0.00%)	1 / 282 (0.35%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	2 / 282 (0.71%)	0 / 282 (0.00%)	0 / 284 (0.00%)
occurrences causally related to treatment / all	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Methotrexate Monotherapy	Etanercept Monotherapy	Etanercept + Methotrexate
Total subjects affected by non serious adverse events
subjects affected / exposed	89 / 282 (31.56%)	75 / 282 (26.60%)	109 / 284 (38.38%)
Nervous system disorders
Headache
subjects affected / exposed	15 / 282 (5.32%)	12 / 282 (4.26%)	17 / 284 (5.99%)
occurrences all number	16	17	22
Gastrointestinal disorders
Diarrhoea
subjects affected / exposed	17 / 282 (6.03%)	13 / 282 (4.61%)	14 / 284 (4.93%)
occurrences all number	23	17	15
Nausea
subjects affected / exposed	37 / 282 (13.12%)	18 / 282 (6.38%)	41 / 284 (14.44%)
occurrences all number	48	26	57
Vomiting
subjects affected / exposed	15 / 282 (5.32%)	7 / 282 (2.48%)	10 / 284 (3.52%)
occurrences all number	28	10	14
Infections and infestations
Bronchitis
subjects affected / exposed	9 / 282 (3.19%)	12 / 282 (4.26%)	18 / 284 (6.34%)
occurrences all number	10	13	20
Nasopharyngitis
subjects affected / exposed	22 / 282 (7.80%)	21 / 282 (7.45%)	27 / 284 (9.51%)
occurrences all number	25	23	34
Upper respiratory tract infection
subjects affected / exposed	21 / 282 (7.45%)	18 / 282 (6.38%)	23 / 284 (8.10%)
occurrences all number	28	23	30

More information

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Were there any global substantial amendments to the protocol? Yes

20 May 2015

- reporting of hepatotoxicity as a serious adverse event was clarified - etanercept indications in US and Canada were updated/clarified - updated inclusion/exclusion criteria regarding tender and swollen joint counts, minimum number of stable dosing for NSAIDS, excluded medications, and minimum number of months since use of excluded medications - clarified joint assessments and allowed for assessment by principal investigators; added folinic acid dosing information and additional information regarding laboratory assessments to determine subject eligibility - Clarified process for inadvertent blinding - Administrative corrections and clarifications were made throughout

09 Jul 2015

- several secondary endpoints to assess disease activity (DAS-28, SDAI, and CDAI) were added - clarifications to psoriatic arthritis disease assessments were made

30 Oct 2015

- updated to be consistent with international regulations and requirements, including those regarding tuberculosis screening in the setting of anti-TNF therapy

31 Aug 2016

- to reflect the most recent version, CTCAE grading was updated to version 4.0 - added language for confirmatory reflex testing by HBV DNA PCR for subjects with Hepatitis-B positive core antibody

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Multicenter Double-blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

Primary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24

Secondary: Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24

Secondary: Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24

Secondary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time

Secondary: Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time

Secondary: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time

Secondary: Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time

Secondary: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time

Secondary: Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time

Secondary: Change From Baseline in Tender Joint Count Over Time

Secondary: Change From Baseline in Tender Joint Count Over Time

Secondary: Change From Baseline in Swollen Joint Count Over Time

Secondary: Change From Baseline in Swollen Joint Count Over Time

Secondary: Change From Baseline in Physician Global Assessment of Disease Activity Over Time

Secondary: Change From Baseline in Physician Global Assessment of Disease Activity Over Time

Secondary: Change From Baseline in Patient Global Assessment of Disease Activity Over Time

Secondary: Change From Baseline in Patient Global Assessment of Disease Activity Over Time

Secondary: Change From Baseline in Patient Global Assessment of Joint Pain Over Time

Secondary: Change From Baseline in Patient Global Assessment of Joint Pain Over Time

Secondary: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time

Secondary: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time

Secondary: Change From Baseline in C-reactive Protein Concentration Over Time

Secondary: Change From Baseline in C-reactive Protein Concentration Over Time

Secondary: Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time

Secondary: Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time

Secondary: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time

Secondary: Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time

Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time

Secondary: Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time

Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time

Secondary: Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time

Secondary: Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time

Secondary: Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time

Secondary: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24

Secondary: Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24

Secondary: Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24

Secondary: Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24

Secondary: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24

Secondary: Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24

Secondary: Percentage of Participants With Clear mNAPSI at Week 24

Secondary: Percentage of Participants With Clear mNAPSI at Week 24

Secondary: Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24

Secondary: Change from Baseline in Leeds Dactylitis Index (LDI) at Week 24

Secondary: Percentage of Participants With Clear LDI at Week 24

Secondary: Percentage of Participants With Clear LDI at Week 24

Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24

Secondary: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24

Secondary: Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24

Secondary: Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24

Secondary: Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24

Secondary: Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24

Secondary: Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups

Secondary: Percent Improvement from Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups

Secondary: Static Physician Global Assessment (sPGA) at Week 24

Secondary: Static Physician Global Assessment (sPGA) at Week 24

Secondary: Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Mean Static Physician Global Assessment (sPGA) Score at Week 24

Secondary: Mean Static Physician Global Assessment (sPGA) Score at Week 24

Secondary: Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24

Secondary: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24

Secondary: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24

Secondary: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24

Secondary: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups

Secondary: Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups

Clinical Trial Results:
A Multicenter Double-blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis