Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Uno studio per determinare l'efficacia e la sicurezza di Deucravacitinib rispetto al placebo nei partecipanti con artrite psoriasica attiva (AP) che sono naïve ai farmaci antireumatici modificanti la malattia biologica

24 settembre 2026 aggiornato da: Bristol-Myers Squibb

Uno studio di fase 3, randomizzato, in doppio cieco, controllato con placebo per valutare l'efficacia e la sicurezza di Deucravacitinib nei partecipanti con artrite psoriasica attiva che sono naïve ai farmaci antireumatici modificanti la malattia biologica

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.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

670

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Placebo
Altro: Placebo

Specified dose on specified days
Sperimentale: Deucravacitinib
Droga: Deucravacitinib

Specified dose on specified days

Altri nomi:
  • BMS-986165

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants With ACR 20 Response at Week 16
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bristol-Myers Squibb

Investigatori

  • Direttore dello studio: Bristol-Myers Squibb, Bristol-Myers Squibb

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 luglio 2021

Completamento primario (Effettivo)

10 ottobre 2024

Completamento dello studio (Stimato)

3 giugno 2027

Date di iscrizione allo studio

Primo inviato

28 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

28 maggio 2021

Primo Inserito (Effettivo)

1 giugno 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

16 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IM011-054
  • U1111-1259-9443 (Identificatore di registro: WHO)
  • 2023-506256-25 (Altro identificatore: EU Trial Number)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano 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

Periodo di condivisione IPD

See Plan Description

Criteri di accesso alla condivisione IPD

See Plan Description

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Sottoscrivi