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Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02376790
Recruitment Status : Completed
First Posted : March 3, 2015
Results First Posted : February 22, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Etanercept Drug: Methotrexate Drug: Placebo to Etanercept Drug: Placebo to Methotrexate Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 851 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
Actual Study Start Date : March 3, 2015
Actual Primary Completion Date : January 9, 2018
Actual Study Completion Date : July 6, 2018


Arm Intervention/treatment
Active Comparator: Methotrexate Monotherapy
Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
Drug: Methotrexate
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.

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

Experimental: Etanercept Monotherapy
Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
Drug: Etanercept
Etanercept was administered by subcutaneous injection once a week
Other Name: Enbrel

Drug: Placebo to Methotrexate
Placebo to methotrexate capsules taken orally once a week.

Experimental: Methotrexate + Etanercept
Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.
Drug: Etanercept
Etanercept was administered by subcutaneous injection once a week
Other Name: Enbrel

Drug: Methotrexate
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.




Primary Outcome Measures :
  1. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 24 [ Time Frame: Baseline and 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 :
  1. Percentage of Participants With a Minimal Disease Activity (MDA) Response at Week 24 [ Time Frame: 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

  2. Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]

    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.

  3. Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]

    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.

  4. Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]

    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.

  5. Change From Baseline in Tender Joint Count Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    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.

  6. Change From Baseline in Swollen Joint Count Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    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.

  7. Change From Baseline in Physician Global Assessment of Disease Activity Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    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.

  8. Change From Baseline in Patient Global Assessment of Disease Activity Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    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.

  9. Change From Baseline in Patient Global Assessment of Joint Pain Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    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.

  10. Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    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.

  11. Change From Baseline in C-reactive Protein Concentration Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]
    C-reactive protein (CRP) is a specific measure of inflammatory activity.

  12. Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time [ Time Frame: Weeks 4, 8, 12, 24, 36, and 48 ]

    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

  13. Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) Over Time [ Time Frame: Baseline and weeks 12, 24, 36, and 48 ]

    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.


  14. Change From Baseline in Clinical Disease Activity Index (CDAI) Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]

    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.


  15. Change From Baseline in Simplified Disease Activity Index (SDAI) Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]

    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.


  16. Change From Baseline in the Disease Activity Score 28 (DAS28) Over Time [ Time Frame: Baseline and weeks 4, 8, 12, 16, 24, 36, and 48 ]

    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.


  17. Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) at Week 24 [ Time Frame: Baseline and 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.

  18. Change From Baseline in Medical Outcomes Health Survey Short Form 36 Items Version 2 (SF-36 v2) at Week 24 [ Time Frame: Baseline and 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.

  19. Change From Baseline in Modified Nail Psoriasis Severity Index (mNAPSI) at Week 24 [ Time Frame: Baseline and 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.


  20. Percentage of Participants With Clear mNAPSI at Week 24 [ Time Frame: Baseline and 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. Clear mNAPSI is defined as a score = 0.


  21. Change From Baseline in Leeds Dactylitis Index (LDI) at Week 24 [ Time Frame: Baseline and 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.

  22. Percentage of Participants With Clear LDI at Week 24 [ Time Frame: Baseline and 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.

    Clear LDI is defined as a score = 0.


  23. Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 24 [ Time Frame: Baseline and 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.

  24. Percentage of Participants With Clear SPARCC Enthesitis Index Score at Week 24 [ Time Frame: Baseline and 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.

    Clear SPARCC enthesitis is defined as a score = 0.


  25. Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis at Week 24 [ Time Frame: Baseline and 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


  26. Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups [ Time Frame: Baseline and 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


  27. Static Physician Global Assessment (sPGA) at Week 24 [ Time Frame: 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)

    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).

  28. Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups [ Time Frame: 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)

    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).

  29. Mean Static Physician Global Assessment (sPGA) Score at Week 24 [ Time Frame: 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)

    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).

  30. Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups [ Time Frame: 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)

    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).

  31. Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 [ Time Frame: 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)

    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).

  32. Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups [ Time Frame: 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)

    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).

  33. Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 [ Time Frame: Baseline and 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)

    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).

  34. Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups [ Time Frame: Baseline and 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)

    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).

  35. Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 [ Time Frame: Baseline and 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)

    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).

  36. Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups [ Time Frame: Baseline and 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)

    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376790


  Show 138 Study Locations
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
  Study Documents (Full-Text)

Documents provided by Amgen:
Study Protocol  [PDF] August 31, 2016
Statistical Analysis Plan  [PDF] June 6, 2018


Additional Information:
Publications:
Philip Mease, M.D.,1* Dafna Gladman, M.D.,2 David H Collier, M.D.,3 Christopher T. Ritchlin, M.D., M.P.H.,4 Philip Helliwell, M.D.,5 Lyrica Liu, Ph.D.,3 Greg Kricorian, M.D.,3 James B. Chung, M.D., Ph.D.3. Etanercept and Methotrexate as Monotherapy or in Combination to Treat Patients With Psoriatic Arthritis. Arthritis Rheumatol.

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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02376790     History of Changes
Other Study ID Numbers: 20130207
2014-004869-24 ( EudraCT Number )
First Posted: March 3, 2015    Key Record Dates
Results First Posted: February 22, 2019
Last Update Posted: March 6, 2019
Last Verified: March 2019
Keywords provided by Amgen:
Psoriatic Arthritis
Arthritis, Psoriasis
Etanercept
Enbrel
Methotrexate
Minimal Disease Activity
Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Etanercept
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal