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Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Etanercept

Methotrexate

Placebo to Etanercept

Placebo to Methotrexate

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic Arthritis, Arthritis, Psoriasis, Etanercept, Enbrel, Methotrexate, Minimal Disease Activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria.
Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline.
Subject has an active psoriatic skin lesion
Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis.
Subject has no prior use of methotrexate for PsA.
Subject has no history of tuberculosis
Subject has a negative test for tuberculosis, hepatitis B and C.

Exclusion Criteria:

Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection.
Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product.
Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Methotrexate Monotherapy

Etanercept Monotherapy

Methotrexate + Etanercept

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

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

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

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

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

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.

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

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.

Change From Baseline in Tender Joint Count Over Time

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.

Change From Baseline in Swollen Joint Count Over Time

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.

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

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.

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

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.

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

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.

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

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.

Change From Baseline in C-reactive Protein Concentration Over Time

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

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

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

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

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.

Percentage of Participants With Clear mNAPSI at Week 24

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

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.

Percentage of Participants With Clear LDI at Week 24

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

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.

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

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

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

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

Static Physician Global Assessment (sPGA) at Week 24

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) = almost clear (minimal plaque elevation, erythema or scaling) = mild (mild plaque elevation or scaling, light red coloration) = moderate (moderate plaque elevation, scaling, light red coloration) = marked (marked plaque elevation, thick, non-tenacious scale predominates, bright red coloration) = severe (severe plaque elevation, very thick tenacious scaling, dusky to deep red coloration).

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

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

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

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

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

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

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

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

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

Full Information

NCT ID

NCT02376790

First Posted

January 28, 2015

Last Updated

September 8, 2022

Sponsor

Amgen

1. Study Identification

Unique Protocol Identification Number

NCT02376790

Brief Title

Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Official Title

A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

March 3, 2015 (Actual)

Primary Completion Date

January 9, 2018 (Actual)

Study Completion Date

July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amgen

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to learn more about the role of etanercept alone or in combination with methotrexate on disease activity in adults with psoriatic arthritis.

Detailed Description

The study will consist of a 30-day screening period, a 48-week double-blind treatment period and a 30-day safety follow-up period. At or after week 24, participants with an inadequate response could receive rescue therapy with etanercept plus methotrexate until the end of the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

Psoriatic Arthritis, Arthritis, Psoriasis, Etanercept, Enbrel, Methotrexate, Minimal Disease Activity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

851 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Methotrexate Monotherapy

Arm Type

Active Comparator

Arm Description

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

Arm Title

Etanercept Monotherapy

Arm Type

Experimental

Arm Description

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

Arm Title

Methotrexate + Etanercept

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Etanercept

Other Intervention Name(s)

Enbrel

Intervention Description

Etanercept was administered by subcutaneous injection once a week

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo to Etanercept

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo to Methotrexate

Intervention Description

Placebo to methotrexate capsules taken orally once a week.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline and week 24

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change From Baseline in Tender Joint Count Over Time

Description

Time Frame

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

Title

Change From Baseline in Swollen Joint Count Over Time

Description

Time Frame

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

Title

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

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.

Time Frame

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

Title

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

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.

Time Frame

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

Title

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

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.

Time Frame

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

Title

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

Description

Time Frame

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

Title

Change From Baseline in C-reactive Protein Concentration Over Time

Description

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

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline and weeks 12, 24, 36, and 48

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

Percentage of Participants With Clear mNAPSI at Week 24

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

Percentage of Participants With Clear LDI at Week 24

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

Static Physician Global Assessment (sPGA) at Week 24

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

Title

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

Description

Time Frame

Baseline and week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Key Inclusion Criteria: Subject must have a diagnosis of psoriatic arthritis (PsA) by the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria. Subject has ≥ 3 tender and ≥ 3 swollen joints at screening and at baseline. Subject has an active psoriatic skin lesion Subject is naïve to etanercept and any other biologic for the treatment for PsA or psoriasis. Subject has no prior use of methotrexate for PsA. Subject has no history of tuberculosis Subject has a negative test for tuberculosis, hepatitis B and C. Exclusion Criteria: Subject has known history of alcoholic hepatitis, nonalcoholic steatohepatitis or immunodeficiency syndromes, including human immunodeficiency virus (HIV) infection. Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to the first dose of investigational product. Subject has a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first dose of investigational product.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Organizational Affiliation

Amgen

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35406

Country

United States

Facility Name

Research Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Research Site

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85202

Country

United States

Facility Name

Research Site

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85258

Country

United States

Facility Name

Research Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Research Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Research Site

City

Hemet

State/Province

California

ZIP/Postal Code

92543

Country

United States

Facility Name

Research Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Research Site

City

Mather

State/Province

California

ZIP/Postal Code

95655

Country

United States

Facility Name

Research Site

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Research Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Research Site

City

Santa Monica

State/Province

California

ZIP/Postal Code

90404

Country

United States

Facility Name

Research Site

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91360

Country

United States

Facility Name

Research Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Research Site

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Research Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Research Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Research Site

City

Ocoee

State/Province

Florida

ZIP/Postal Code

34761

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Research Site

City

Zephyrhills

State/Province

Florida

ZIP/Postal Code

33542

Country

United States

Facility Name

Research Site

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Research Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Research Site

City

Bowling Green

State/Province

Kentucky

ZIP/Postal Code

42101

Country

United States

Facility Name

Research Site

City

Paducah

State/Province

Kentucky

ZIP/Postal Code

42003

Country

United States

Facility Name

Research Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

Research Site

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Research Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

Research Site

City

Worcester

State/Province

Massachusetts

ZIP/Postal Code

01605

Country

United States

Facility Name

Research Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

Country

United States

Facility Name

Research Site

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48917

Country

United States

Facility Name

Research Site

City

Saint Clair Shores

State/Province

Michigan

ZIP/Postal Code

48081

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

Research Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Research Site

City

Clifton

State/Province

New Jersey

ZIP/Postal Code

07012

Country

United States

Facility Name

Research Site

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87102

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Research Site

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Research Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44109

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Research Site

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Research Site

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Research Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Research Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Research Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78232

Country

United States

Facility Name

Research Site

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

Research Site

City

Danville

State/Province

Virginia

ZIP/Postal Code

24541

Country

United States

Facility Name

Research Site

City

Roanoke

State/Province

Virginia

ZIP/Postal Code

24016

Country

United States

Facility Name

Research Site

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

Facility Name

Research Site

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Research Site

City

San Miguel de Tucuman

State/Province

Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

Research Site

City

Buenos Aires

ZIP/Postal Code

1425

Country

Argentina

Facility Name

Research Site

City

Burgas

ZIP/Postal Code

8000

Country

Bulgaria

Facility Name

Research Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Research Site

City

Rouse

ZIP/Postal Code

7002

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

Facility Name

Research Site

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3R 6A7

Country

Canada

Facility Name

Research Site

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3N 0K6

Country

Canada

Facility Name

Research Site

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 3H7

Country

Canada

Facility Name

Research Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

Research Site

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

Research Site

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7K 3H3

Country

Canada

Facility Name

Research Site

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7501126

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

7640881

Country

Chile

Facility Name

Research Site

City

Santiago

ZIP/Postal Code

8420383

Country

Chile

Facility Name

Research Site

City

Brno

ZIP/Postal Code

638 00

Country

Czechia

Facility Name

Research Site

City

Ostrava-Trebovice

ZIP/Postal Code

722 00

Country

Czechia

Facility Name

Research Site

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

Research Site

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

Research Site

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

Research Site

City

Lyon Cédex 3

ZIP/Postal Code

69437

Country

France

Facility Name

Research Site

City

Poitiers

ZIP/Postal Code

86000

Country

France

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11521

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Research Site

City

Athens

ZIP/Postal Code

12462

Country

Greece

Facility Name

Research Site

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Research Site

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Research Site

City

Szolnok

ZIP/Postal Code

5000

Country

Hungary

Facility Name

Research Site

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Research Site

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Research Site

City

Liepaja

ZIP/Postal Code

3401

Country

Latvia

Facility Name

Research Site

City

Riga

ZIP/Postal Code

1003

Country

Latvia

Facility Name

Research Site

City

Valmiera

ZIP/Postal Code

4201

Country

Latvia

Facility Name

Research Site

City

Mexicali

State/Province

Baja California Norte

ZIP/Postal Code

21100

Country

Mexico

Facility Name

Research Site

City

Mexicalli

State/Province

Baja California Norte

ZIP/Postal Code

21200

Country

Mexico

Facility Name

Research Site

City

Guadalajara

State/Province

Jalisco

ZIP/Postal Code

44650

Country

Mexico

Facility Name

Research Site

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

45190

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64020

Country

Mexico

Facility Name

Research Site

City

Monterrey

State/Province

Nuevo León

ZIP/Postal Code

64718

Country

Mexico

Facility Name

Research Site

City

Culiacan

State/Province

Sinaloa

ZIP/Postal Code

80000

Country

Mexico

Facility Name

Research Site

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

Research Site

City

Gdansk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

Research Site

City

Lodz

ZIP/Postal Code

90-436

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-817

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

50-368

Country

Poland

Facility Name

Research Site

City

Wroclaw

ZIP/Postal Code

51-318

Country

Poland

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1050-034

Country

Portugal

Facility Name

Research Site

City

Lisboa

ZIP/Postal Code

1649-034

Country

Portugal

Facility Name

Research Site

City

Ponte de Lima

ZIP/Postal Code

4990-041

Country

Portugal

Facility Name

Research Site

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Research Site

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Research Site

City

Chelyabinsk

ZIP/Postal Code

454076

Country

Russian Federation

Facility Name

Research Site

City

Ekaterinburg

ZIP/Postal Code

620102

Country

Russian Federation

Facility Name

Research Site

City

Kemerovo

ZIP/Postal Code

650000

Country

Russian Federation

Facility Name

Research Site

City

Kursk

ZIP/Postal Code

305007

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

119992

Country

Russian Federation

Facility Name

Research Site

City

Novosibirsk

ZIP/Postal Code

630005

Country

Russian Federation

Facility Name

Research Site

City

Orenburg

ZIP/Postal Code

460018

Country

Russian Federation

Facility Name

Research Site

City

Petrozavodsk

ZIP/Postal Code

185019

Country

Russian Federation

Facility Name

Research Site

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Research Site

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Research Site

City

Smolensk

ZIP/Postal Code

214025

Country

Russian Federation

Facility Name

Research Site

City

Vladimir

ZIP/Postal Code

600023

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150062

Country

Russian Federation

Facility Name

Research Site

City

Panorama

State/Province

Western Cape

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Research Site

City

Pinelands

State/Province

Western Cape

ZIP/Postal Code

7405

Country

South Africa

Facility Name

Research Site

City

Stellenbosch

State/Province

Western Cape

ZIP/Postal Code

7600

Country

South Africa

Facility Name

Research Site

City

Cordoba

State/Province

Andalucía

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site

City

La Vila-Joiosa

State/Province

Comunidad Valenciana

ZIP/Postal Code

03570

Country

Spain

Facility Name

Research Site

City

Merida

State/Province

Extremadura

ZIP/Postal Code

06800

Country

Spain

Facility Name

Research Site

City

A Coruña

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Research Site

City

Bradford

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

Facility Name

Research Site

City

Dudley

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Research Site

City

Nottingham

ZIP/Postal Code

NG7 2UH

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

29531787

Citation

Mease PJ, Gladman DD, Samad AS, Coates LC, Liu LXH, Aras GA, Collier DH, Chung JB. Design and rationale of the Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects with Psoriatic Arthritis (SEAM-PsA). RMD Open. 2018 Feb 3;4(1):e000606. doi: 10.1136/rmdopen-2017-000606. eCollection 2018.

Results Reference

background

PubMed Identifier

30747501

Citation

Mease PJ, Gladman DD, Collier DH, Ritchlin CT, Helliwell PS, Liu L, Kricorian G, Chung JB. Etanercept and Methotrexate as Monotherapy or in Combination for Psoriatic Arthritis: Primary Results From a Randomized, Controlled Phase III Trial. Arthritis Rheumatol. 2019 Jul;71(7):1112-1124. doi: 10.1002/art.40851. Epub 2019 May 28.

Results Reference

background

PubMed Identifier

33452180

Citation

Strand V, Mease PJ, Maksabedian Hernandez EJ, Stolshek BS, Liu LXH, Collier DH, Kricorian G, Merola JF. Patient-reported outcomes data in patients with psoriatic arthritis from a randomised trial of etanercept and methotrexate as monotherapy or in combination. RMD Open. 2021 Jan;7(1):e001484. doi: 10.1136/rmdopen-2020-001484.

Results Reference

background

PubMed Identifier

32864685

Citation

Coates LC, Merola JF, Mease PJ, Ogdie A, Gladman DD, Strand V, van Mens LJJ, Liu L, Yen PK, Collier DH, Kricorian G, Chung JB, Helliwell PS. Performance of composite measures used in a trial of etanercept and methotrexate as monotherapy or in combination in psoriatic arthritis. Rheumatology (Oxford). 2021 Mar 2;60(3):1137-1147. doi: 10.1093/rheumatology/keaa271.

Results Reference

background

PubMed Identifier

35863864

Citation

Helliwell PS, Mease PJ, Kavanaugh A, Coates LC, Ogdie A, Deodhar A, Strand V, Kricorian G, Liu LXH, Collier D, Gladman DD. Impact of clinical domains other than arthritis on composite outcomes in psoriatic arthritis: comparison of treatment effects in the SEAM-PsA trial. RMD Open. 2022 Jul;8(2):e002366. doi: 10.1136/rmdopen-2022-002366.

Results Reference

background

Links:

URL

http://www.amgentrials.com

Description

AmgenTrials clinical trials website

Learn more about this trial

Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

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Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

Psoriatic Arthritis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial