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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02376790
Other study ID # 20130207
Secondary ID 2014-004869-24
Status Completed
Phase Phase 3
First received
Last updated
Start date March 3, 2015
Est. completion date July 6, 2018

Study information

Verified date September 2022
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 851
Est. completion date July 6, 2018
Est. primary completion date January 9, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Etanercept
Etanercept was administered by subcutaneous injection once a week
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.
Placebo to Etanercept
Placebo to etanercept was administered by subcutaneous injection once a week.
Placebo to Methotrexate
Placebo to methotrexate capsules taken orally once a week.

Locations

Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Ciudad Autonoma de Buenos Aires Buenos Aires
Argentina Research Site San Miguel de Tucuman Tucuman
Bulgaria Research Site Burgas
Bulgaria Research Site Pleven
Bulgaria Research Site Plovdiv
Bulgaria Research Site Rouse
Bulgaria Research Site Sofia
Bulgaria Research Site Sofia
Canada Research Site London Ontario
Canada Research Site Quebec
Canada Research Site Saskatoon Saskatchewan
Canada Research Site Surrey British Columbia
Canada Research Site Toronto Ontario
Canada Research Site Trois-Rivieres Quebec
Canada Research Site Winnipeg Manitoba
Chile Research Site Santiago
Chile Research Site Santiago
Chile Research Site Santiago
Czechia Research Site Brno
Czechia Research Site Ostrava-Trebovice
Czechia Research Site Pardubice
Czechia Research Site Praha 2
Czechia Research Site Praha 2
Czechia Research Site Uherske Hradiste
Czechia Research Site Zlin
France Research Site Lyon Cédex 3
France Research Site Poitiers
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Athens
Greece Research Site Thessaloniki
Hungary Research Site Budapest
Hungary Research Site Nyiregyhaza
Hungary Research Site Szolnok
Hungary Research Site Szombathely
Hungary Research Site Veszprem
Latvia Research Site Liepaja
Latvia Research Site Riga
Latvia Research Site Valmiera
Mexico Research Site Chihuahua
Mexico Research Site Culiacan Sinaloa
Mexico Research Site Guadalajara Jalisco
Mexico Research Site Mexicali Baja California Norte
Mexico Research Site Mexicalli Baja California Norte
Mexico Research Site Monterrey Nuevo León
Mexico Research Site Monterrey Nuevo León
Mexico Research Site Zapopan Jalisco
Poland Research Site Gdansk
Poland Research Site Lodz
Poland Research Site Warszawa
Poland Research Site Wroclaw
Poland Research Site Wroclaw
Portugal Research Site Lisboa
Portugal Research Site Lisboa
Portugal Research Site Ponte de Lima
Puerto Rico Research Site Ponce
Puerto Rico Research Site San Juan
Russian Federation Research Site Chelyabinsk
Russian Federation Research Site Ekaterinburg
Russian Federation Research Site Kemerovo
Russian Federation Research Site Kursk
Russian Federation Research Site Moscow
Russian Federation Research Site Moscow
Russian Federation Research Site Novosibirsk
Russian Federation Research Site Orenburg
Russian Federation Research Site Petrozavodsk
Russian Federation Research Site Ryazan
Russian Federation Research Site Saratov
Russian Federation Research Site Smolensk
Russian Federation Research Site Vladimir
Russian Federation Research Site Yaroslavl
Russian Federation Research Site Yaroslavl
South Africa Research Site Panorama Western Cape
South Africa Research Site Pinelands Western Cape
South Africa Research Site Stellenbosch Western Cape
Spain Research Site A Coruña Galicia
Spain Research Site Cordoba Andalucía
Spain Research Site La Vila-Joiosa Comunidad Valenciana
Spain Research Site Merida Extremadura
United Kingdom Research Site Bradford
United Kingdom Research Site Dudley
United Kingdom Research Site Nottingham
United States Research Site Albuquerque New Mexico
United States Research Site Asheville North Carolina
United States Research Site Aventura Florida
United States Research Site Bowling Green Kentucky
United States Research Site Charleston South Carolina
United States Research Site Charlotte North Carolina
United States Research Site Chesapeake Virginia
United States Research Site Chicago Illinois
United States Research Site Clearwater Florida
United States Research Site Cleveland Ohio
United States Research Site Clifton New Jersey
United States Research Site Dallas Texas
United States Research Site Danville Virginia
United States Research Site Duncansville Pennsylvania
United States Research Site Escondido California
United States Research Site Frederick Maryland
United States Research Site Freehold New Jersey
United States Research Site Glendale Arizona
United States Research Site Hagerstown Maryland
United States Research Site Hemet California
United States Research Site Kissimmee Florida
United States Research Site Lansing Michigan
United States Research Site Lansing Michigan
United States Research Site Las Vegas Nevada
United States Research Site Lebanon New Hampshire
United States Research Site Little Rock Arkansas
United States Research Site Los Angeles California
United States Research Site Mather California
United States Research Site Meridian Idaho
United States Research Site Mesa Arizona
United States Research Site New York New York
United States Research Site Ocoee Florida
United States Research Site Oklahoma City Oklahoma
United States Research Site Paducah Kentucky
United States Research Site Palm Desert California
United States Research Site Rapid City South Dakota
United States Research Site Roanoke Virginia
United States Research Site Rochester New York
United States Research Site Rochester Minnesota
United States Research Site Saint Clair Shores Michigan
United States Research Site San Antonio Texas
United States Research Site San Francisco California
United States Research Site Santa Monica California
United States Research Site Scottsdale Arizona
United States Research Site Seattle Washington
United States Research Site Springfield Illinois
United States Research Site Tampa Florida
United States Research Site Tampa Florida
United States Research Site Thousand Oaks California
United States Research Site Tuscaloosa Alabama
United States Research Site Tustin California
United States Research Site Wheaton Maryland
United States Research Site Worcester Massachusetts
United States Research Site Wyomissing Pennsylvania
United States Research Site Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Canada,  Chile,  Czechia,  France,  Greece,  Hungary,  Latvia,  Mexico,  Poland,  Portugal,  Puerto Rico,  Russian Federation,  South Africa,  Spain,  United Kingdom, 

References & Publications (5)

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. — View 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). pii: e002366. doi: 10.1136/rmdopen-2022-002366. — View 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. — View 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. — View 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). pii: e001484. doi: 10.1136/rmdopen-2020-001484. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Baseline and week 24
Secondary 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
Week 24
Secondary Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response Over Time 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.
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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.
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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.
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary Change From Baseline in C-reactive Protein Concentration Over Time C-reactive protein (CRP) is a specific measure of inflammatory activity. Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary Percentage of Participants With a American Minimal Disease Activity (MDA) Response Over Time 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
Weeks 4, 8, 12, 24, 36, and 48
Secondary 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.
Baseline and weeks 12, 24, 36, and 48
Secondary 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.
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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.
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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.
Baseline and weeks 4, 8, 12, 16, 24, 36, and 48
Secondary 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. Baseline and week 24
Secondary 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. Baseline and week 24
Secondary 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.
Baseline and week 24
Secondary Percentage of Participants With Clear 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. Clear mNAPSI is defined as a score = 0.
Baseline and week 24
Secondary 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. Baseline and week 24
Secondary Percentage of Participants With Clear 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.
Clear LDI is defined as a score = 0.
Baseline and week 24
Secondary 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. Baseline and week 24
Secondary Percentage of Participants With Clear SPARCC Enthesitis Index Score 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.
Clear SPARCC enthesitis is defined as a score = 0.
Baseline and week 24
Secondary 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
Baseline and week 24
Secondary Percent Improvement From Baseline in the Percentage of Body Surface Area (BSA) Involved in Psoriasis by Baseline BSA Involvement Subgroups 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
Baseline and week 24
Secondary 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).
Week 24
Secondary Static Physician Global Assessment (sPGA) at Week 24 by Baseline BSA Involvement Subgroups 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).
Week 24
Secondary Mean Static Physician Global Assessment (sPGA) Score 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).
Week 24
Secondary Mean Static Physician Global Assessment (sPGA) Score at Week 24 by Baseline BSA Involvement Subgroups 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).
Week 24
Secondary Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) 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).
Week 24
Secondary Percentage of Participants With an sPGA Score of 0 (Clear) or 1 (Almost Clear) at Week 24 by Baseline BSA Involvement Subgroups 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).
Week 24
Secondary Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline 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).
Baseline and week 24
Secondary Percentage of Participants With at Least a 1 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups 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).
Baseline and week 24
Secondary Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline 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).
Baseline and week 24
Secondary Percentage of Participants With at Least a 2 Grade Improvement in sPGA From Baseline at Week 24 by Baseline BSA Involvement Subgroups 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).
Baseline and week 24
See also
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