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Исследование по определению эффективности и безопасности деукравацитиниба по сравнению с плацебо у участников с активным псориатическим артритом (ПсА), которые ранее не принимали антиревматические препараты, модифицирующие биологическое заболевание

24 сентября 2026 г. обновлено: Bristol-Myers Squibb

Фаза 3, рандомизированное, двойное слепое, плацебо-контролируемое исследование для оценки эффективности и безопасности деукравацитиниба у участников с активным псориатическим артритом, которые ранее не принимали антиревматические препараты, модифицирующие биологические заболевания

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Обзор исследования

Статус

Активный, не рекрутирующий

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

670

Фаза

  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Австралия
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Австралия, 2606
        • Local Institution - 0220
    • New South Wales
      • Botany, New South Wales, Австралия, 2019
        • Local Institution - 0137
      • Westmead, New South Wales, Австралия, 2145
        • Local Institution - 0133
    • Queensland
      • Woolloongabba, Queensland, Австралия, 4102
        • Local Institution - 0132
    • Tasmania
      • Hobart, Tasmania, Австралия, 7000
        • Local Institution - 0211
    • Victoria
      • Camberwell, Victoria, Австралия, 3142
        • Local Institution - 0136
  • Аргентина
      • Buenos Aires, Аргентина, 1426
        • Local Institution - 0194
      • Buenos Aires, Аргентина, 1428
        • Local Institution - 0169
      • Buenos Aires, Аргентина, C1427CCL
        • Local Institution - 0192
      • Mendoza, Аргентина, 5500
        • Local Institution - 0193
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Аргентина, 1111
        • Local Institution - 0213
      • La Plata, Buenos Aires, Аргентина, 1900
        • Local Institution - 0054
      • Quilmes, Buenos Aires, Аргентина, 1878
        • Local Institution - 0215
    • Córdoba Province
      • Córdoba, Córdoba Province, Аргентина, X5004CDT
        • Local Institution - 0046
    • Santa Fe Province
      • Rosario, Santa Fe Province, Аргентина, S2000
        • Local Institution - 0196
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Аргентина, 4000
        • Local Institution - 0047
  • Болгария
      • Burgas, Болгария, 8000
        • Local Institution - 0253
      • Plovdiv, Болгария, 4000
        • Local Institution - 0249
      • Plovdiv, Болгария, 4000
        • Local Institution - 0267
      • Plovdiv, Болгария, 4001
        • Local Institution - 0246
      • Plovdiv, Болгария, 4001
        • Local Institution - 0247
      • Sofia, Болгария, 1505
        • Local Institution - 0245
      • Sofia, Болгария, 1784
        • Local Institution - 0259
      • Varna, Болгария, 9000
        • Local Institution - 0250
    • Plovdiv
      • Plovdiv, Plovdiv, Болгария, 4002
        • Local Institution - 0255
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Болгария, 1463
        • Local Institution - 0248
  • Бразилия
    • Espírito Santo
      • Vitória, Espírito Santo, Бразилия, 29055450
        • Local Institution - 0109
    • Estado de Bahia
      • Salvador, Estado de Bahia, Бразилия, 40150-150
        • Local Institution - 0001
    • Minas Gerais
      • Juiz de Fora, Minas Gerais, Бразилия, 36010-570
        • Local Institution - 0002
    • Paraná
      • Curitiba, Paraná, Бразилия, 80030110
        • Local Institution - 0219
      • Curitiba, Paraná, Бразилия, 80440-080
        • Local Institution - 0214
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Бразилия, 90480-000
        • Local Institution - 0005
    • São Paulo
      • Santo André, São Paulo, Бразилия, 09060-870
        • Local Institution - 0108
  • Венгрия
      • Budapest, Венгрия, 1027
        • Local Institution - 0023
      • Budapest, Венгрия, 1027
        • Local Institution - 0142
      • Budapest, Венгрия, 1033
        • Local Institution - 0026
      • Budapest, Венгрия, 1036
        • Local Institution - 0025
      • Budapest, Венгрия, 1036
        • Local Institution - 0203
      • Zalaegerszeg, Венгрия, 8900
        • Local Institution - 0068
    • Bekes County
      • Gyula, Bekes County, Венгрия, 5700
        • Local Institution - 0270
    • Fejér
      • Székesfehérvár, Fejér, Венгрия, 8000
        • Local Institution - 0049
  • Ирландия
      • Dublin, Ирландия, 4
        • Local Institution - 0101
      • Dublin, Ирландия, D15 X40D
        • Local Institution - 0102
      • Galway, Ирландия, H91 TY80
        • Local Institution - 0103
    • Leitrim
      • Manorhamilton, Leitrim, Ирландия, F91 X012
        • Local Institution - 0104
  • Испания
      • A Coruña, Испания, 15006
        • Local Institution - 0021
      • Córdoba, Испания, 14004
        • Local Institution - 0022
      • Madrid, Испания, 28046
        • Local Institution - 0019
      • Sabadell, Испания, 08208
        • Local Institution - 0020
  • Италия
      • Genova, Италия, 16132
        • Local Institution - 0066
      • Pavia, Италия, 27100
        • Local Institution - 0062
      • Udine, Италия, 33100
        • Local Institution - 0096
      • Verona, Италия, 37134
        • Local Institution - 0058
  • Китай
    • Anhui
      • Hefei, Anhui, Китай, 230071
        • Local Institution - 0149
    • Beijing Municipality
      • Beijing, Beijing Municipality, Китай, 100005
        • Local Institution - 0159
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Китай, 400010
        • Local Institution - 0190
    • Guangdong
      • Guangzhou, Guangdong, Китай, 510120
        • Local Institution - 0147
      • Shenzhen, Guangdong, Китай, 518020
        • Local Institution - 0143
    • Liaoning
      • Dalian, Liaoning, Китай, 116000
        • Local Institution - 0150
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Китай, 200040
        • Local Institution - 0146
    • Zhejiang
      • Yiwu, Zhejiang, Китай, 322000
        • Local Institution - 0145
  • Колумбия
      • Barranquilla, Колумбия, 080020
        • Local Institution - 0072
      • Bogotá, Колумбия, 110221
        • Local Institution - 0069
      • Bogotá, Колумбия, 111156
        • Local Institution - 0063
      • Cali, Колумбия, 760042
        • Local Institution - 0070
      • Medellín, Колумбия, 050021
        • Local Institution - 0094
      • Medellín, Колумбия, 050034
        • Local Institution - 0064
      • Zipaquirá, Колумбия, 250252
        • Local Institution - 0065
    • Santander Department
      • Bucaramanga, Santander Department, Колумбия, 680003
        • Local Institution - 0071
  • Мексика
      • Chihuahua City, Мексика, 31000
        • Local Institution - 0060
      • Mexico City, Мексика, 14080
        • Local Institution - 0209
      • Veracruz, Мексика, 91900
        • Local Institution - 0095
    • Coahuila
      • Saltillo, Coahuila, Мексика, 25050
        • Local Institution - 0056
    • Jalisco
      • Guadalajara, Jalisco, Мексика, 44610
        • Local Institution - 0254
    • Mexico City
      • Mexico City, Mexico City, Мексика, 06720
        • Local Institution - 0057
    • San Luis Potosí
      • San Luis Potosí City, San Luis Potosí, Мексика, 78200
        • Local Institution - 0128
    • Yucatán
      • Mérida, Yucatán, Мексика, 97070
        • Local Institution - 0061
      • Mérida, Yucatán, Мексика, 97070
        • Local Institution - 0212
  • Польша
      • Bialystok, Польша, 15-351
        • Local Institution - 0114
      • Krakow, Польша, 31-501
        • Local Institution - 0140
      • Krakow, Польша, 30-002
        • Local Institution - 0126
      • Krakow, Польша, 30-033
        • Local Institution - 0127
      • Olsztyn, Польша, 10-117
        • Local Institution - 0162
      • Poznan, Польша, 60-218
        • Local Institution - 0113
      • Poznan, Польша, 60-773
        • Local Institution - 0112
      • Poznan, Польша, 60-702
        • Local Institution - 0239
      • Warsaw, Польша, 00-874
        • Local Institution - 0204
      • Warsaw, Польша, 02-118
        • Local Institution - 0205
      • Warsaw, Польша, 03-291
        • Local Institution - 0125
      • Wroclaw, Польша, 52-210
        • Local Institution - 0210
    • Greater Poland Voivodeship
      • Dąbrówka, Greater Poland Voivodeship, Польша, 62-069
        • Local Institution - 0231
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Польша, 30-149
        • Local Institution - 0229
      • Nowy Targ, Lesser Poland Voivodeship, Польша, 34-400
        • Local Institution - 0206
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Польша, 50-381
        • Local Institution - 0244
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Польша, 20-607
        • Local Institution - 0232
      • Świdnik, Lublin Voivodeship, Польша, 21-040
        • Local Institution - 0230
    • Masovian Voivodeship
      • Nadarzyn, Masovian Voivodeship, Польша, 05-830
        • Local Institution - 0233
      • Warsaw, Masovian Voivodeship, Польша, 02-665
        • Local Institution - 0235
      • Warsaw, Masovian Voivodeship, Польша, 02-672
        • Local Institution - 0243
      • Wołomin, Masovian Voivodeship, Польша, 05-200
        • Local Institution - 0236
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Польша, 80-382
        • Local Institution - 0257
      • Gdynia, Pomeranian Voivodeship, Польша, 31-338
        • Local Institution - 0234
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Польша, 42-202
        • Local Institution - 0241
      • Katowice, Silesian Voivodeship, Польша, 40-040
        • Local Institution - 0252
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Польша, 90-368
        • Local Institution - 0238
  • Россия
      • Kemerovo, Россия, 650070
        • Local Institution
      • Korolyov, Россия, 141060
        • Local Institution
      • Saint Petersburg, Россия, 194214
        • Local Institution
      • Yaroslavl, Россия, 150003
        • Local Institution
  • Румыния
      • Brasov, Румыния, 500283
        • Local Institution - 0012
      • Bucharest, Румыния, 011025
        • Local Institution - 0167
      • Bucharest, Румыния, 030463
        • Local Institution - 0263
      • Bucharest, Румыния, 11057
        • Local Institution - 0184
      • Bucharest, Румыния, 014142
        • Local Institution - 0260
      • Cluj-Napoca, Румыния, 400006
        • Local Institution - 0011
      • Craiova, Румыния, 200347
        • Local Institution - 0258
      • Iași, Румыния, 700127
        • Local Institution - 0262
      • Iași, Румыния, 700661
        • Local Institution - 0265
      • Iași, Румыния, 700714
        • Local Institution - 0264
      • Timișoara, Румыния, 300778
        • Local Institution - 0091
    • Bucharest
      • Bucharest, Bucharest, Румыния, 011172
        • Local Institution - 0090
      • Bucharest, Bucharest, Румыния, 020125
        • Local Institution - 0266
    • Vâlcea County
      • Râmnicu Vâlcea, Vâlcea County, Румыния, 247065
        • Local Institution - 0010
  • Соединенное Королевство
      • Harlow, Соединенное Королевство, CM227NR
        • Local Institution - 0116
      • Stoke-on-Trent, Соединенное Королевство, ST6 7AG
        • Local Institution - 0107
    • Hampshire
      • Southampton, Hampshire, Соединенное Королевство, SO16 6YD
        • Local Institution - 0106
  • Соединенные Штаты
    • Arizona
      • Gilbert, Arizona, Соединенные Штаты, 85297
        • Local Institution - 0197
    • Arkansas
      • Jonesboro, Arkansas, Соединенные Штаты, 72401
        • Local Institution - 0188
    • California
      • Fontana, California, Соединенные Штаты, 92335
        • Local Institution - 0168
      • Fullerton, California, Соединенные Штаты, 92835
        • Local Institution - 0199
      • Sacramento, California, Соединенные Штаты, 95815
        • Local Institution - 0038
      • Thousand Oaks, California, Соединенные Штаты, 91360
        • Cohen Medical Centers
    • Colorado
      • Denver, Colorado, Соединенные Штаты, 80230
        • Local Institution - 0170
    • Florida
      • Clearwater, Florida, Соединенные Штаты, 33765
        • Local Institution - 0195
      • Margate, Florida, Соединенные Штаты, 33063
        • Local Institution - 0272
      • Miami Lakes, Florida, Соединенные Штаты, 33014
        • Local Institution - 0082
    • Georgia
      • Gainesville, Georgia, Соединенные Штаты, 30501
        • Local Institution - 0171
    • Idaho
      • Boise, Idaho, Соединенные Штаты, 83702
        • Local Institution - 0087
    • Illinois
      • Chicago, Illinois, Соединенные Штаты, 60640
        • Local Institution - 0080
      • Orland Park, Illinois, Соединенные Штаты, 60467
        • Local Institution - 0177
      • Schaumburg, Illinois, Соединенные Штаты, 60195
        • Local Institution - 0178
    • Kentucky
      • Lexington, Kentucky, Соединенные Штаты, 40504
        • Local Institution - 0083
    • Maryland
      • Hagerstown, Maryland, Соединенные Штаты, 21740
        • Local Institution - 0042
    • Michigan
      • Detroit, Michigan, Соединенные Штаты, 48202
        • Local Institution - 0198
    • Missouri
      • Springfield, Missouri, Соединенные Штаты, 65807
        • Local Institution - 0201
    • Montana
      • Kalispell, Montana, Соединенные Штаты, 59901
        • Local Institution - 0268
    • New Jersey
      • Voorhees Township, New Jersey, Соединенные Штаты, 08043
        • Local Institution - 0186
    • Ohio
      • Cleveland, Ohio, Соединенные Штаты, 44106
        • University Hospitals Cleveland Medical Center-Dermatology
      • Middleburg Heights, Ohio, Соединенные Штаты, 44130
        • Local Institution - 0028
      • Perrysburg, Ohio, Соединенные Штаты, 43551
        • Local Institution - 0179
    • Oklahoma
      • Oklahoma City, Oklahoma, Соединенные Штаты, 73102
        • Local Institution - 0182
    • Oregon
      • Corvallis, Oregon, Соединенные Штаты, 97330
        • Local Institution - 0185
    • South Carolina
      • Greenville, South Carolina, Соединенные Штаты, 29601
        • Local Institution - 0175
    • Tennessee
      • Jackson, Tennessee, Соединенные Штаты, 38305
        • Local Institution - 0036
    • Texas
      • Allen, Texas, Соединенные Штаты, 75013
        • Local Institution - 0172
      • Amarillo, Texas, Соединенные Штаты, 79124
        • Local Institution - 0189
      • Dallas, Texas, Соединенные Штаты, 75231
        • Local Institution - 0032
    • Washington
      • Bothell, Washington, Соединенные Штаты, 98021
        • Local Institution - 0273
    • West Virginia
      • Beckley, West Virginia, Соединенные Штаты, 25801
        • Local Institution - 0181
  • Тайвань
      • Kaohsiung City, Тайвань, 833401
        • Local Institution - 0123
      • Tainan, Тайвань, 704
        • Local Institution - 0121
      • Tainan, Тайвань, 710
        • Local Institution - 0122
      • Taipei, Тайвань, 110
        • Local Institution - 0120
      • Taoyuan, Тайвань, 333423
        • Local Institution - 0124
  • Финляндия
      • Helsinki, Финляндия, 00290
        • Local Institution - 0013
      • Kuopio, Финляндия, 70100
        • Local Institution - 0089
      • Turku, Финляндия, FI-20521
        • Local Institution - 0119
  • Франция
      • Chambray-lès-Tours, Франция, 37170
        • Local Institution - 0077
      • Montpellier, Франция, 34295
        • Local Institution - 0075
      • Paris, Франция, 75010
        • Local Institution - 0074
  • Чехия
      • Ostrava, Чехия, 722 00
        • Local Institution - 0018
      • Pardubice, Чехия, 530 02
        • Local Institution - 0208
      • Prague, Чехия, 12850
        • Local Institution - 0097
      • Prague, Чехия, 130 00
        • Local Institution - 0017
    • Praha 5
      • Prague, Praha 5, Чехия, 150 06
        • Local Institution - 0225
    • Zlín
      • Uherské Hradiště, Zlín, Чехия, 68601
        • Local Institution - 0269
      • Zlín, Zlín, Чехия, 760 01
        • Local Institution - 0202
  • Чили
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Чили
        • Local Institution - 0226
      • Santiago, Santiago Metropolitan, Чили, 7500571
        • Local Institution - 0099
      • Santiago, Santiago Metropolitan, Чили, 7501126
        • Local Institution - 0073
      • Santiago, Santiago Metropolitan, Чили, 7510047
        • Local Institution - 0222
      • Santiago, Santiago Metropolitan, Чили, 7640881
        • Local Institution - 0111
    • Valparaiso
      • Viña del Mar, Valparaiso, Чили, 2531172
        • Local Institution - 0261

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

Inclusion Criteria

  • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.
  • Meets the Classification Criteria for Psoriatic Arthritis at Screening.
  • Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening.
  • Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1.
  • Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening.
  • ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.
  • Must have completed the week 52 treatment for the optional open-label long-term extension period.

Exclusion Criteria

  • Nonplaque psoriasis at screening or day 1.
  • Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
  • History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
  • Active fibromyalgia.
  • Received an approved or investigational biologic therapy for the treatment of PsA or PsO.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Четырехместный

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Плацебо
Другой: Placebo

Specified dose on specified days
Экспериментальный: Деукравацитиниб
Лекарство: Deucravacitinib

Specified dose on specified days

Другие имена:
  • БМС-986165

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With ACR 20 Response at Week 16
Временное ограничение: Week 16

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Week 16

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
Временное ограничение: Baseline and Week 16

DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: < 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; >5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Baseline and Week 16
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16
Временное ограничение: Baseline and Week 16

HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Baseline and Week 16
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
Временное ограничение: Week 16

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Week 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16
Временное ограничение: Baseline and Week 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Baseline and Week 16
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Временное ограничение: Week 16

Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Week 16
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Временное ограничение: Week 16

Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:

  1. Tender joint count <= 1
  2. Swollen joint count <=1
  3. Psoriasis Area and Severity Index (PASI) <= 1 or body surface area (BSA) <= 3%
  4. Patient assessment of psoriatic arthiritis (PsA) pain <= 15
  5. Patient Global Assessment of PsA disease activity <= 20
  6. HAQ-DI <= 0.5
  7. Tender enthesial points <= 1
Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
Временное ограничение: Baseline and Week 16

FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Baseline and Week 16
Percentage of Participants Meeting Dactylitis Resolution at Week 16
Временное ограничение: Week 16

Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count => 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Week 16
Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16
Временное ограничение: Baseline and Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. Change from baseline reflects progression or improvement; a decrease suggests reduced damage or improvement.
Baseline and Week 16
Percentage of Participants With ACR 20 Response up to Week 16
Временное ограничение: Week 2, 4, 8, 12, and 16

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Week 2, 4, 8, 12, and 16
Percentage of Participants With ACR 50 Response up to Week 16
Временное ограничение: Week 2, 4, 8, 12, and 16

The ACR 50 definition of improvement is a 50% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 50% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Week 2, 4, 8, 12, and 16
Percentage of Participants With ACR 70 Response up to Week 16
Временное ограничение: Week 2, 4, 8, 12, and 16

The ACR 70 definition of improvement is a 70% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 70% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Week 2, 4, 8, 12, and 16
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12, and 16

HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Baseline and Week 2, 4, 8, 12, and 16
Percentage of Participants Who Achieve a Clinically Meaningful Improvement in Health Assessment Questionnaire - Disability Index (HAQ-DI) up to Week 16 Among Participants With a HAQ-DI Score ≥0.35 at Baseline
Временное ограничение: Baseline and Week 2, 4, 8, 12, and 16

HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Clinically meaningful improvement was defined as ≥0.35improvement from baseline.
Baseline and Week 2, 4, 8, 12, and 16
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
Временное ограничение: Week 4, 8, 12 and 16

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Week 4, 8, 12 and 16
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 90 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
Временное ограничение: Week 4, 8, 12 and 16

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Week 4, 8, 12 and 16
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 100 Response up to Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline
Временное ограничение: Week 4, 8, 12 and 16

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. The 95% CI is calculated using Clopper-Pearson exact method.
Week 4, 8, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Baseline and Week 4, 12 and 16
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) up to Week 16
Временное ограничение: Week 4, 8, 12 and 16

Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden.
Week 4, 8, 12 and 16
Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) up to Week 16
Временное ограничение: Week 4, 8, 12 and 16

Percentage of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right \[R\]/left \[L\]), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
Week 4, 8, 12 and 16
Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) up to Week 16
Временное ограничение: Week 4, 8, 12, and 16

Percentage of participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:

  1. Tender joint count <= 1
  2. Swollen joint count <=1
  3. Psoriasis Area and Severity Index (PASI) <= 1 or body surface area (BSA) <= 3%
  4. Patient assessment of psoriatic arthiritis (PsA) pain <= 15
  5. Patient Global Assessment of PsA disease activity <= 20
  6. HAQ-DI <= 0.5
  7. Tender enthesial points <= 1
Week 4, 8, 12, and 16
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating poor quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12 and 16

FACIT-Fatigue evaluates a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Baseline and Week 2, 4, 8, 12 and 16
Percentage of Participants Meeting Dactylitis Resolution up to Week 16
Временное ограничение: Week 4, 8, 12 and 16

Percentage of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count => 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Week 4, 8, 12 and 16
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12 and 16

The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
Baseline and Week 2, 4, 8, 12 and 16
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12 and 16

The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. The DAPSA score ranges from 0 to 154, with a higher score indicating more disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
Baseline and Week 2, 4, 8, 12 and 16
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12 and 16

The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Baseline and Week 2, 4, 8, 12 and 16
Percentage of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12 and 16

The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter \[cm\] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. A score 0 signifies remission.
Baseline and Week 2, 4, 8, 12 and 16
Percentage of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 up to Week 16
Временное ограничение: Week 2, 4, 8, 12 and 16

The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe. The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Week 2, 4, 8, 12 and 16
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) up to Week 16
Временное ограничение: Baseline and Week 2, 4, 8, 12 and 16

DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Baseline and Week 2, 4, 8, 12 and 16
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Low Disease Activity Response up to Week 16
Временное ограничение: Week 2, 4, 8, 12 and 16

DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity.
Week 2, 4, 8, 12 and 16
Percentage of Participants Meeting Disease Activity Score 28 C-reactive Protein (DAS28-CRP) Disease Remission up to Week 16
Временное ограничение: Week 2, 4, 8, 12 and 16

DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: \< 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; \>5.1=high disease activity.
Week 2, 4, 8, 12 and 16
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI) up to Week 16
Временное ограничение: Baseline and Week 4, 8, 12 and 16

Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline and Week 4, 8, 12 and 16
Percentage of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC) up to Week 16
Временное ограничение: Week 2, 4, 8, 12 and 16

The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity
Week 2, 4, 8, 12 and 16
Percentage of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score up to Week 16
Временное ограничение: Week 2, 4, 8, 12 and 16

BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Week 2, 4, 8, 12 and 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0 at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= 0.5 at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Scores Response of <= Smallest Detectable Change (SDC) at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96* standard deviation of the paired differences of change from baseline/ square root of (2*k); k is the number of reviewers and is default to 2 in this study.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0 at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= 0.5 at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Erosion Scores Response of <= SDC at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96* standard deviation of the paired differences of change from baseline/ square root of (2*k); k is the number of reviewers and is default to 2 in this study.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0 at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= 0.5 at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Week 16
Percentage of Participants Meeting Achievement of Total PsA-modified SvdH Joint Space Narrowing (JSN) Scores Response of <= SDC at Week 16
Временное ограничение: Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. SDC is calculated as 1.96* standard deviation of the paired differences of change from baseline/ square root of (2*k); k is the number of reviewers and is default to 2 in this study.
Week 16
Change From Baseline in PsA-modified SvdH Erosion Scores Response at Week 16
Временное ограничение: Baseline and Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Baseline and Week 16
Change From Baseline in PsA-modified SvdH JSN Scores Response at Week 16
Временное ограничение: Baseline and Week 16

The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage.
Baseline and Week 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical sub component is one of the 4 subscales of PCS. The physical subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 physical sub-component indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Role Activity Subcomponent Summary Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The role activity sub component is one of the 4 subscales of PCS. The role activity subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 role activity indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Bodily Pain Subcomponent Summary Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The bodily pain sub component is one of the 4 subscales of PCS. The bodily pain subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 bodily pain subcomponent indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) General Health Perceptions Subcomponent Summary Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The general health perceptions sub component is one of the 4 subscales of PCS. The general health perceptions subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 general health perceptions subcomponent indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Vitality Subcomponent Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The vitality subcomponent is one of the 4 subscales of MCS. The vitality subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 vitality subcomponent indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Social Subcomponent Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The social subcomponent is one of the 4 subscales of MCS. The social subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 social subcomponent indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Mental Health Subcomponent Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental health subcomponent is one of the 4 subscales of MCS. The mental health subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 mental health subcomponent indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the 36-item Short Form (SF-36) Emotional Problems Subcomponent Score up to Week 16
Временное ограничение: Baseline and Week 4, 12 and 16

SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The emotional problem subcomponent is one of the 4 subscales of MCS. The emotional problem subcomponent scores will be calculated by taking a weighted linear combination of the individual question. The score ranges from 0 to 100, with higher values indication poor quality of life. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 emotional problems subcomponent indicates an improvement.
Baseline and Week 4, 12 and 16
Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Subcomponents Score at Week 16
Временное ограничение: Baseline and week 16

WPAI contains 4 subcomponents - absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. Each subcomponent score ranges from 0 to 100, with higher numbers indicating worse outcome. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline and week 16
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents up to 16
Временное ограничение: Baseline and week 4 and 16

The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline and week 4 and 16
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS) Sleep Disturbance up to Week 16
Временное ограничение: Baseline and week 4, 12, and 16

The Patient-Reported Outcome Measures Information System Sleep Disturbance assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline and week 4, 12, and 16

Соавторы и исследователи

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Спонсор

Bristol-Myers Squibb

Следователи

  • Директор по исследованиям: Bristol-Myers Squibb, Bristol-Myers Squibb

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Полезные ссылки

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

13 июля 2021 г.

Первичное завершение (Действительный)

10 октября 2024 г.

Завершение исследования (Оцененный)

3 июня 2027 г.

Даты регистрации исследования

Первый отправленный

28 мая 2021 г.

Впервые представлено, что соответствует критериям контроля качества

28 мая 2021 г.

Первый опубликованный (Действительный)

1 июня 2021 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • IM011-054
  • U1111-1259-9443 (Идентификатор реестра: WHO)
  • 2023-506256-25 (Другой идентификатор: EU Trial Number)
  • 2023 (Грант/контракт NIH США)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Сроки обмена IPD

See Plan Description

Критерии совместного доступа к IPD

See Plan Description

Совместное использование IPD Поддерживающий тип информации

  • STUDY_PROTOCOL
  • САП
  • КСО

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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