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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 or Had Previously Received TNFα Inhibitor Treatment

Primary Purpose

Psoriatic Arthritis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Deucravacitinib
Placebo
Apremilast
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic arthritis, PsA, Deucravacitinib, BMS-986165, Apremilast, Otezla

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
  • Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria 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
  • 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

Sites / Locations

  • Local Institution - 0149
  • First OC Dermatology-Dermatology
  • Local Institution - 0212
  • Local Institution - 0188
  • Bay Area Arthritis and Osteoporosis
  • Local Institution - 0192
  • Local Institution - 0203
  • Local Institution - 0195
  • Local Institution - 0169
  • Local Institution - 0034
  • Local Institution - 0133
  • Local Institution - 0109
  • Local Institution - 0108
  • Local Institution - 0186
  • Local Institution - 0196
  • Local Institution - 0180
  • Local Institution - 0189
  • Local Institution - 0147
  • Local Institution - 0016
  • Local Institution - 0182
  • Local Institution - 0167
  • Local Institution - 0070
  • Local Institution - 0184
  • Local Institution - 0187
  • University Of Washington
  • Local Institution - 0190
  • Local Institution - 0175
  • Hospital Italiano de La Plata
  • Local Institution - 0038
  • Local Institution - 0039
  • Local Institution - 0171
  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
  • Local Institution - 0037
  • Local Institution - 0168
  • Local Institution - 0003
  • BJC Health
  • Local Institution - 0004
  • Local Institution - 0099
  • Emeritus Research
  • Local Institution - 0017
  • Local Institution - 0078
  • Local Institution - 0058
  • Local Institution - 0104
  • Local Institution - 0061
  • Local Institution - 0111
  • Local Institution - 0006
  • Local Institution - 0030
  • Local Institution - 0036
  • Local Institution - 0001
  • Local Institution - 0126
  • Local Institution - 0152
  • Local Institution - 0146
  • Local Institution - 0153
  • Local Institution - 0135
  • Local Institution - 0206
  • Local Institution - 0127
  • Local Institution - 0170
  • Local Institution - 0161
  • Local Institution - 0125
  • Local Institution - 0138
  • Local Institution - 0139
  • Local Institution - 0163
  • Local Institution - 0148
  • Local Institution - 0131
  • Local Institution - 0156
  • Local Institution - 0140
  • Local Institution - 0191
  • Local Institution - 0158
  • Local Institution - 0157
  • Local Institution - 0154
  • Local Institution - 0207
  • Local Institution - 0164
  • Local Institution - 0117
  • Local Institution - 0134
  • Local Institution - 0129
  • Local Institution - 0020
  • Local Institution - 0072
  • Local Institution - 0015
  • Local Institution - 0022
  • Local Institution - 0019
  • Local Institution - 0010
  • Local Institution - 0009
  • Local Institution - 0035
  • Local Institution - 0011
  • Local Institution - 0023
  • Local Institution - 0176
  • Local Institution - 0100
  • Local Institution - 0199
  • Local Institution - 0046
  • Local Institution - 0101
  • Local Institution - 0075
  • Local Institution - 0201
  • Local Institution - 0074
  • Local Institution - 0197
  • Local Institution - 0066
  • Local Institution - 0028
  • Local Institution - 0027
  • Local Institution - 0024
  • Local Institution - 0025
  • Azienda Ospedaliera Universitaria Careggi-Reumatologia
  • AOR San Carlo di Potenza-UOC Reumatologia
  • Fondazione Policlinico Universitario Agostino Gemelli-UOC Reumatologia
  • Local Institution - 0106
  • Local Institution - 0202
  • Local Institution - 0151
  • Local Institution - 0179
  • Local Institution - 0123
  • Local Institution - 0205
  • Local Institution - 0121
  • Local Institution - 0067
  • Local Institution - 0178
  • Local Institution - 0122
  • Local Institution - 0174
  • Local Institution - 0065
  • Local Institution - 0155
  • Local Institution - 0166
  • Local Institution - 0204
  • Local Institution - 0198
  • Local Institution - 0052
  • Local Institution - 0051
  • Local Institution - 0057
  • Local Institution - 0056
  • Local Institution - 0053
  • Local Institution - 0082
  • Local Institution - 0177
  • Local Institution - 0079
  • Local Institution - 0080
  • Local Institution - 0081
  • Local Institution - 0112
  • Local Institution - 0208
  • Local Institution
  • Local Institution - 0145
  • Local Institution - 0014
  • Local Institution - 0012
  • Local Institution - 0045
  • Local Institution - 0013
  • Local Institution - 0090
  • Local Institution - 0088
  • Local Institution - 0089
  • Local Institution - 0091
  • Local Institution - 0087
  • Local Institution - 0185
  • Local Institution - 0060
  • Local Institution - 0064
  • Local Institution - 0077
  • Local Institution - 0062
  • Local Institution - 0105

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Other

Arm Label

Deucravacitinib

Placebo

Apremilast

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20)

Secondary Outcome Measures

Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP)
Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI)
Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response
Change from baseline Short Form-36 Physical Component Survey (SF-36 PCS) score
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)
Proportion of participants meeting achievement of Minimal Disease Activity (MDA)
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
Proportion of participants meeting ACR 20 response
Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response
Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response
Change from baseline in HAQ-DI score
Proportion of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline
Proportion of participants meeting PASI 75 response
Proportion of participants meeting PASI 90 response
Proportion of participants meeting PASI 100 response
Change from baseline in the SF-36 PCS score
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Proportion of participants meeting achievement of MDA
Change from baseline in SF-36 Mental Component Summary (MCS) score
Change from baseline in FACIT-Fatigue score
Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
Proportion of participants with achievement of DAPSA low disease activity response
Proportion of participants with achievement of DAPSA disease remission
Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of ≥ 3
Change from baseline in DAS28-CRP score
Proportion of participants with achievement of a DAS28-CRP low disease activity response
Proportion of participants with achievement of a DAS28-CRP disease remission
Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score
Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)
Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA
Change from baseline in domain scales scores of SF-36
Change from baseline in PCS score of SF-36
Change from baseline in MCS score of SF- 36
Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire
Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D-5L) utility scores
Change from baseline in the 5-level EQ-5D utility score subcomponents
Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)
Incidence of Adverse Events (AEs)
Incidence of Serious Adverse Events (SAEs)

Full Information

First Posted
May 28, 2021
Last Updated
October 13, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04908189
Brief Title
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 or Had Previously Received TNFα Inhibitor Treatment
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
December 5, 2023 (Anticipated)
Study Completion Date
August 5, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
Keywords
Psoriatic arthritis, PsA, Deucravacitinib, BMS-986165, Apremilast, Otezla

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deucravacitinib
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Apremilast
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Other Intervention Name(s)
BMS-986165
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
Apremilast
Other Intervention Name(s)
Otezla
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20)
Time Frame
At week 16
Secondary Outcome Measure Information:
Title
Change from baseline Disease Activity Score 28 with C-Reactive Protein (DAS28-CRP)
Time Frame
At week 16
Title
Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame
At week 16
Title
Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response
Time Frame
At week 16
Title
Change from baseline Short Form-36 Physical Component Survey (SF-36 PCS) score
Time Frame
At week 16
Title
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)
Time Frame
At week 16
Title
Proportion of participants meeting achievement of Minimal Disease Activity (MDA)
Time Frame
At week 16
Title
Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score
Time Frame
At week 16
Title
Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
Time Frame
At week 16
Title
Proportion of participants meeting ACR 20 response
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR 50) response
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR 70) response
Time Frame
Up to 16 weeks
Title
Change from baseline in HAQ-DI score
Time Frame
Up to 16 weeks
Title
Proportion of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting PASI 75 response
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting PASI 90 response
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting PASI 100 response
Time Frame
Up to 16 weeks
Title
Change from baseline in the SF-36 PCS score
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting achievement of MDA
Time Frame
Up to 16 weeks
Title
Change from baseline in SF-36 Mental Component Summary (MCS) score
Time Frame
Up to 16 weeks
Title
Change from baseline in FACIT-Fatigue score
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
Time Frame
Up to 16 weeks
Title
Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 score
Time Frame
Up to 16 weeks
Title
Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
Time Frame
Up to 16 weeks
Title
Proportion of participants with achievement of DAPSA low disease activity response
Time Frame
Up to 16 weeks
Title
Proportion of participants with achievement of DAPSA disease remission
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of ≥ 3
Time Frame
Up to 16 weeks
Title
Change from baseline in DAS28-CRP score
Time Frame
Up to 16 weeks
Title
Proportion of participants with achievement of a DAS28-CRP low disease activity response
Time Frame
Up to 16 weeks
Title
Proportion of participants with achievement of a DAS28-CRP disease remission
Time Frame
Up to 16 weeks
Title
Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
Time Frame
Up to 16 weeks
Title
Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score
Time Frame
Up to 16 weeks
Title
Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)
Time Frame
Up to 16 weeks
Title
Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA
Time Frame
Up to 16 weeks
Title
Change from baseline in domain scales scores of SF-36
Time Frame
Up to 16 weeks
Title
Change from baseline in PCS score of SF-36
Time Frame
Up to 16 weeks
Title
Change from baseline in MCS score of SF- 36
Time Frame
Up to 16 weeks
Title
Change from baseline in the subcomponents of the Work Productivity and Activity Impairment (WPAI) questionnaire
Time Frame
Up to 16 weeks
Title
Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D-5L) utility scores
Time Frame
Up to 16 weeks
Title
Change from baseline in the 5-level EQ-5D utility score subcomponents
Time Frame
Up to 16 weeks
Title
Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleep disturbance score (short form)
Time Frame
Up to 16 weeks
Title
Incidence of Adverse Events (AEs)
Time Frame
Up to week 156
Title
Incidence of Serious Adverse Events (SAEs)
Time Frame
Up to week 156

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 0149
City
Mountain Brook
State/Province
Alabama
ZIP/Postal Code
35223
Country
United States
Facility Name
First OC Dermatology-Dermatology
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Local Institution - 0212
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Local Institution - 0188
City
Whittier
State/Province
California
ZIP/Postal Code
90602
Country
United States
Facility Name
Bay Area Arthritis and Osteoporosis
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Local Institution - 0192
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Local Institution - 0203
City
Hopkinsville
State/Province
Kentucky
ZIP/Postal Code
42240
Country
United States
Facility Name
Local Institution - 0195
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Facility Name
Local Institution - 0169
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Facility Name
Local Institution - 0034
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Local Institution - 0133
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Local Institution - 0109
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
Local Institution - 0108
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Local Institution - 0186
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Local Institution - 0196
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Local Institution - 0180
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Local Institution - 0189
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Local Institution - 0147
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Local Institution - 0016
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Local Institution - 0182
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
Local Institution - 0167
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Facility Name
Local Institution - 0070
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Local Institution - 0184
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Local Institution - 0187
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Local Institution - 0190
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Facility Name
Local Institution - 0175
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Hospital Italiano de La Plata
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Local Institution - 0038
City
San Isidro
State/Province
Buenos Aires
ZIP/Postal Code
1642
Country
Argentina
Facility Name
Local Institution - 0039
City
Caba
State/Province
Distrito Federal
ZIP/Postal Code
C1015
Country
Argentina
Facility Name
Local Institution - 0171
City
San Miguel de Tucumán
State/Province
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Local Institution - 0037
City
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Local Institution - 0168
City
Cordoba
ZIP/Postal Code
0
Country
Argentina
Facility Name
Local Institution - 0003
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Facility Name
BJC Health
City
Paramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Local Institution - 0004
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Local Institution - 0099
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Local Institution - 0017
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Local Institution - 0078
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution - 0058
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0104
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0061
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution - 0111
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E8
Country
Canada
Facility Name
Local Institution - 0006
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Local Institution - 0030
City
Markham
State/Province
Ontario
ZIP/Postal Code
L3P 1X2
Country
Canada
Facility Name
Local Institution - 0036
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S6
Country
Canada
Facility Name
Local Institution - 0001
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Local Institution - 0126
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Facility Name
Local Institution - 0152
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Local Institution - 0146
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Local Institution - 0153
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510180
Country
China
Facility Name
Local Institution - 0135
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510317
Country
China
Facility Name
Local Institution - 0206
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Facility Name
Local Institution - 0127
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Facility Name
Local Institution - 0170
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Local Institution - 0161
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Facility Name
Local Institution - 0125
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Facility Name
Local Institution - 0138
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Local Institution - 0139
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Facility Name
Local Institution - 0163
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Local Institution - 0148
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Facility Name
Local Institution - 0131
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution - 0156
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Local Institution - 0140
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Facility Name
Local Institution - 0191
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Facility Name
Local Institution - 0158
City
Baotou
State/Province
Neimeng
ZIP/Postal Code
014010
Country
China
Facility Name
Local Institution - 0157
City
Hohhot
State/Province
Neimeng
ZIP/Postal Code
010050
Country
China
Facility Name
Local Institution - 0154
City
Xi'An
State/Province
Shan3xi
ZIP/Postal Code
710004
Country
China
Facility Name
Local Institution - 0207
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200052
Country
China
Facility Name
Local Institution - 0164
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610072
Country
China
Facility Name
Local Institution - 0117
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Facility Name
Local Institution - 0134
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650032
Country
China
Facility Name
Local Institution - 0129
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
32500
Country
China
Facility Name
Local Institution - 0020
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760035
Country
Colombia
Facility Name
Local Institution - 0072
City
Barranquilla
ZIP/Postal Code
80002
Country
Colombia
Facility Name
Local Institution - 0015
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Facility Name
Local Institution - 0022
City
Chía
ZIP/Postal Code
250001
Country
Colombia
Facility Name
Local Institution - 0019
City
Medellin
ZIP/Postal Code
50036
Country
Colombia
Facility Name
Local Institution - 0010
City
Brno
ZIP/Postal Code
638 00
Country
Czechia
Facility Name
Local Institution - 0009
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Local Institution - 0035
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Local Institution - 0011
City
Praha 2
ZIP/Postal Code
12850
Country
Czechia
Facility Name
Local Institution - 0023
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Local Institution - 0176
City
Ratingen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40878
Country
Germany
Facility Name
Local Institution - 0100
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Local Institution - 0199
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Local Institution - 0046
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Local Institution - 0101
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0075
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Local Institution - 0201
City
Minden
ZIP/Postal Code
32429
Country
Germany
Facility Name
Local Institution - 0074
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution - 0197
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Local Institution - 0066
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Local Institution - 0028
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Local Institution - 0027
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Local Institution - 0024
City
Szarvas
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Local Institution - 0025
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Azienda Ospedaliera Universitaria Careggi-Reumatologia
City
Firenze
ZIP/Postal Code
50141
Country
Italy
Facility Name
AOR San Carlo di Potenza-UOC Reumatologia
City
Potenza
ZIP/Postal Code
85100
Country
Italy
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli-UOC Reumatologia
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Local Institution - 0106
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution - 0202
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8511
Country
Japan
Facility Name
Local Institution - 0151
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan
Facility Name
Local Institution - 0179
City
Tsu
State/Province
MIE
ZIP/Postal Code
514-8507
Country
Japan
Facility Name
Local Institution - 0123
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
586-8521
Country
Japan
Facility Name
Local Institution - 0205
City
Bunkyō
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Local Institution - 0121
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-8560
Country
Japan
Facility Name
Local Institution - 0067
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
173-0003
Country
Japan
Facility Name
Local Institution - 0178
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1538515
Country
Japan
Facility Name
Local Institution - 0122
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Local Institution - 0174
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Local Institution - 0065
City
Shinjuku-ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Local Institution - 0155
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Local Institution - 0166
City
Osaka
ZIP/Postal Code
545-8585
Country
Japan
Facility Name
Local Institution - 0204
City
Osaka
ZIP/Postal Code
550-0006
Country
Japan
Facility Name
Local Institution - 0198
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Facility Name
Local Institution - 0052
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37160
Country
Mexico
Facility Name
Local Institution - 0051
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution - 0057
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Local Institution - 0056
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Local Institution - 0053
City
Chihuahua
ZIP/Postal Code
31203
Country
Mexico
Facility Name
Local Institution - 0082
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 0177
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-665
Country
Poland
Facility Name
Local Institution - 0079
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Local Institution - 0080
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution - 0081
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution - 0112
City
Wrocław
ZIP/Postal Code
50-088
Country
Poland
Facility Name
Local Institution - 0208
City
Saint Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
107045
Country
Russian Federation
Facility Name
Local Institution - 0145
City
Saint Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Local Institution - 0014
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0012
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Local Institution - 0045
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution - 0013
City
València
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution - 0090
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Facility Name
Local Institution - 0088
City
Taichung
ZIP/Postal Code
404332
Country
Taiwan
Facility Name
Local Institution - 0089
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
Local Institution - 0091
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Local Institution - 0087
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Local Institution - 0185
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Local Institution - 0060
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
Local Institution - 0064
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution - 0077
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Local Institution - 0062
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Local Institution - 0105
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
Investigator Inquiry Form

Learn more about this trial

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 or Had Previously Received TNFα Inhibitor Treatment

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