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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

Tracking Information
First Submitted Date  ICMJE January 28, 2015
First Posted Date  ICMJE March 3, 2015
Results First Submitted Date  ICMJE January 8, 2019
Results First Posted Date  ICMJE February 22, 2019
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE March 3, 2015
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
Efficacy as measured by American College of Rheumatology (ACR) 20 response. [ Time Frame: Week 24 ]
Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.
Change History Complete list of historical versions of study NCT02376790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2015)
  • Minimal Disease Activity (MDA) response of arthritis activity. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.
  • Minimal Disease Activity (MDA) response for measures of non-arthritic PSA disease activity. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.
  • Minimal Disease Activity (MDA) response of patient reported outcomes. [ Time Frame: Week 24 ]
    Evaluate the efficacy of etanercept plus methotrexate therapy and etanercept monotherapy compared to methotrexate monotherapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: February 25, 2015)
Adverse Events (AEs) [ Time Frame: 30 days after last dose of IP ]
 
Descriptive Information
Brief Title  ICMJE Etanercept and Methotrexate in Combination or as Monotherapy in Psoriatic Arthritis
Official Title  ICMJE A Multicenter Double-Blind, Randomized Controlled Study of Etanercept and Methotrexate in Combination or as Monotherapy in Subjects With Psoriatic Arthritis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriatic Arthritis
Intervention  ICMJE
  • 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.
  • Drug: Placebo to Etanercept
    Placebo to etanercept was administered by subcutaneous injection once a week.
  • Drug: Placebo to Methotrexate
    Placebo to methotrexate capsules taken orally once a week.
Study Arms  ICMJE
  • Active Comparator: Methotrexate Monotherapy
    Participants received oral methotrexate 20 mg weekly plus placebo to etanercept subcutaneous injection once a week for 48 weeks.
    Interventions:
    • Drug: Methotrexate
    • Drug: Placebo to Etanercept
  • Experimental: Etanercept Monotherapy
    Participants received etanercept 50 mg weekly by subcutaneous injection plus oral placebo to methotrexate for 48 weeks.
    Interventions:
    • Drug: Etanercept
    • Drug: Placebo to Methotrexate
  • Experimental: Methotrexate + Etanercept
    Participants received etanercept 50 mg a week by subcutaneous injection plus oral methotrexate 20 mg weekly for 48 weeks.
    Interventions:
    • Drug: Etanercept
    • Drug: Methotrexate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
851
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2015)
840
Actual Study Completion Date  ICMJE July 6, 2018
Actual Primary Completion Date January 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Mexico,   Argentina,   Bulgaria,   Chile,   Czechia,   France,   Greece,   Hungary,   Latvia,   Poland,   Portugal,   Puerto Rico,   Russian Federation,   South Africa,   Spain,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT02376790
Other Study ID Numbers  ICMJE 20130207
2014-004869-24 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP