A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs

NCT ID: NCT04908202

Last Updated: 2025-10-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

670 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-13

Study Completion Date

2027-06-10

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriatic Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Deucravacitinib

Group Type EXPERIMENTAL

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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Deucravacitinib

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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BMS-986165

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0197

Gilbert, Arizona, United States

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Local Institution - 0188

Jonesboro, Arkansas, United States

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Local Institution - 0168

Fontana, California, United States

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Local Institution - 0199

Fullerton, California, United States

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Local Institution - 0038

Sacramento, California, United States

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Cohen Medical Centers

Thousand Oaks, California, United States

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Local Institution - 0170

Denver, Colorado, United States

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Local Institution - 0195

Clearwater, Florida, United States

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Local Institution - 0272

Margate, Florida, United States

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Local Institution - 0082

Miami Lakes, Florida, United States

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Local Institution - 0171

Gainesville, Georgia, United States

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Local Institution - 0087

Boise, Idaho, United States

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Local Institution - 0080

Chicago, Illinois, United States

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Local Institution - 0177

Orland Park, Illinois, United States

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Local Institution - 0178

Schaumburg, Illinois, United States

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Local Institution - 0083

Lexington, Kentucky, United States

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Local Institution - 0042

Hagerstown, Maryland, United States

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Local Institution - 0198

Detroit, Michigan, United States

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Local Institution - 0201

Springfield, Missouri, United States

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Local Institution - 0268

Kalispell, Montana, United States

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Local Institution - 0186

Voorhees Township, New Jersey, United States

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University Hospitals Cleveland Medical Center-Dermatology

Cleveland, Ohio, United States

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Local Institution - 0028

Middleburg Heights, Ohio, United States

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Local Institution - 0179

Perrysburg, Ohio, United States

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Local Institution - 0182

Oklahoma City, Oklahoma, United States

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Local Institution - 0185

Corvallis, Oregon, United States

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Greenville, South Carolina, United States

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Local Institution - 0036

Jackson, Tennessee, United States

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Allen, Texas, United States

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Local Institution - 0189

Amarillo, Texas, United States

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Dallas, Texas, United States

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Local Institution - 0273

Bothell, Washington, United States

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Local Institution - 0181

Beckley, West Virginia, United States

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Local Institution - 0213

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

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Local Institution - 0054

La Plata, Buenos Aires, Argentina

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Quilmes, Buenos Aires, Argentina

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Local Institution - 0046

Córdoba, Córdoba Province, Argentina

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Local Institution - 0196

Rosario, Santa Fe Province, Argentina

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San Miguel de Tucumán, Tucumán Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Phillip, Australian Capital Territory, Australia

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Botany, New South Wales, Australia

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Westmead, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Local Institution - 0211

Hobart, Tasmania, Australia

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Local Institution - 0136

Camberwell, Victoria, Australia

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Local Institution - 0109

Vitória, Espírito Santo, Brazil

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Local Institution - 0001

Salvador, Estado de Bahia, Brazil

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Juiz de Fora, Minas Gerais, Brazil

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Curitiba, Paraná, Brazil

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Curitiba, Paraná, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Local Institution - 0108

Santo André, São Paulo, Brazil

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Local Institution - 0255

Plovdiv, Plovdiv, Bulgaria

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Sofia, Sofia (stolitsa), Bulgaria

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Burgas, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Plovdiv, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Varna, , Bulgaria

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Santiago, Santiago Metropolitan, Chile

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Hefei, Anhui, China

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Beijing, Beijing Municipality, China

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Chongqing, Chongqing Municipality, China

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Guangzhou, Guangdong, China

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Shenzhen, Guangdong, China

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Dalian, Liaoning, China

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Shanghai, Shanghai Municipality, China

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Yiwu, Zhejiang, China

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Bucaramanga, Santander Department, Colombia

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Medellín, , Colombia

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Medellín, , Colombia

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Zipaquirá, , Colombia

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Prague, Praha 5, Czechia

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Uherské Hradiště, Zlín, Czechia

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Zlín, Zlín, Czechia

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Ostrava, , Czechia

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Pardubice, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Kuopio, Northern Savonia, Finland

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Helsinki, , Finland

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Turku, , Finland

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Chambray-lès-Tours, , France

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Montpellier, , France

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Paris, , France

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Gyula, Bekes County, Hungary

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Székesfehérvár, Fejér, Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Zalaegerszeg, , Hungary

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Manorhamilton, Leitrim, Ireland

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Dublin, , Ireland

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Dublin, , Ireland

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Galway, , Ireland

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Genova, , Italy

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Pavia, , Italy

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Udine, , Italy

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Verona, , Italy

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Saltillo, Coahuila, Mexico

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Guadalajara, Jalisco, Mexico

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Mexico City, Mexico City, Mexico

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San Luis Potosí City, San Luis Potosí, Mexico

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Mérida, Yucatán, Mexico

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Mérida, Yucatán, Mexico

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Chihuahua City, , Mexico

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Mexico City, , Mexico

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Veracruz, , Mexico

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Dąbrówka, Greater Poland Voivodeship, Poland

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Krakow, Lesser Poland Voivodeship, Poland

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Nowy Targ, Lesser Poland Voivodeship, Poland

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Wroclaw, Lower Silesian Voivodeship, Poland

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Lublin, Lublin Voivodeship, Poland

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Świdnik, Lublin Voivodeship, Poland

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Nadarzyn, Masovian Voivodeship, Poland

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Warsaw, Masovian Voivodeship, Poland

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Warsaw, Masovian Voivodeship, Poland

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Wołomin, Masovian Voivodeship, Poland

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Gdansk, Pomeranian Voivodeship, Poland

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Gdynia, Pomeranian Voivodeship, Poland

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Częstochowa, Silesian Voivodeship, Poland

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Katowice, Silesian Voivodeship, Poland

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Bialystok, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Lodz, Łódź Voivodeship, Poland

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Bucharest, București, Romania

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Bucharest, București, Romania

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Râmnicu Vâlcea, Vâlcea County, Romania

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Brasov, , Romania

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Local Institution - 0167

Bucharest, , Romania

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Local Institution - 0260

Bucharest, , Romania

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Local Institution - 0263

Bucharest, , Romania

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Local Institution - 0184

Bucharest, , Romania

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Cluj-Napoca, , Romania

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Local Institution - 0258

Craiova, , Romania

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Iași, , Romania

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Local Institution - 0265

Iași, , Romania

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Iași, , Romania

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Local Institution - 0091

Timișoara, , Romania

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Kemerovo, , Russia

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Korolyov, , Russia

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Saint Petersburg, , Russia

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Yaroslavl, , Russia

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Local Institution - 0021

A Coruña, , Spain

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Córdoba, , Spain

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Madrid, , Spain

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Sabadell, , Spain

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Local Institution - 0123

Kaohsiung City, , Taiwan

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Tainan City, , Taiwan

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Tainan City, , Taiwan

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Local Institution - 0120

Taipei, , Taiwan

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Local Institution - 0124

Taoyuan District, , Taiwan

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Local Institution - 0106

Southampton, Hampshire, United Kingdom

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Local Institution - 0116

Harlow, , United Kingdom

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Local Institution - 0107

Stoke-on-Trent, , United Kingdom

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Countries

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United States Argentina Australia Brazil Bulgaria Chile China Colombia Czechia Finland France Hungary Ireland Italy Mexico Poland Romania Russia Spain Taiwan United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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2023-506256-25

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1259-9443

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM011-054

Identifier Type: -

Identifier Source: org_study_id

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