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A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)

Primary Purpose

Systemic Lupus Erythematosus

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

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, Lupus, SLE, Deucravacitinib, Tyk2, POETYK, POETYK SLE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash •Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant Exclusion Criteria: Diagnosis of drug-induced SLE rather than idiopathic SLE Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS History of congenital or acquired immunodeficiency Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria) Taking more than 1 immunosuppressant at screening Other protocol-defined inclusion/exclusion criteria apply

Sites / Locations

  • Pinnacle Research Group, LLC
  • University of Alabama at BirminghamRecruiting
  • The University of Arizona Arthritis Center
  • Kaiser Permanente
  • Private Practice - Dr. Chandrakant V. Mehta
  • Arthritis & Osteoporosis Medical Center - La PalmaRecruiting
  • UCLA Clinical & Translational Research Center (CTRC)
  • Private Practice - Dr. Hans Richard BarthelRecruiting
  • Denver Arthritis ClinicRecruiting
  • Yale University School of MedicineRecruiting
  • Rheumatology Assoc. Of South Florida
  • Nouvelle Clinical Research
  • University of Florida College of MedicineRecruiting
  • University of Miami Hospital and Clinics, Sylvester Cancer Center
  • Omega Research Group - OrlandoRecruiting
  • West Broward Rheumatology AssociatesRecruiting
  • Genesis Clinical Research, LLC
  • Baycare Medical Group
  • North Georgia Rheumatology
  • Greater Chicago Specialty PhysiciansRecruiting
  • Indiana University Health University HospitalRecruiting
  • Lake Cumberland Rheumatology
  • University of Maryland
  • Henry Ford HospitalRecruiting
  • Saint Paul Rheumatology
  • Atlantic Health System Overlook Medical CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • The Feinstein Institute for Medical Research
  • NYU Langone HealthRecruiting
  • University of Rochester Medical CenterRecruiting
  • Carolinas HealthCare System SouthParkRecruiting
  • STAT Research
  • Shelby Research LLCRecruiting
  • Arthritis & Rheumatology Research InstituteRecruiting
  • UT Southwestern Medical CenterRecruiting
  • Dallas Fort Worth Clinical Research Associates - North Tarrant ParkwayRecruiting
  • Advanced Rheumatology of Houston - WoodlandsRecruiting
  • Carilion ClinicRecruiting
  • Swedish Medical CenterRecruiting
  • University of Washington Medical Center - MontlakeRecruiting
  • Aurora Rheumatology
  • Local Institution - 0140
  • Local Institution - 0078
  • Local Institution - 0013
  • Local Institution - 0020Recruiting
  • Local Institution - 0123
  • Local Institution - 0032
  • Local Institution - 0022
  • Local Institution - 0138
  • Local Institution - 0017
  • Local Institution - 0096
  • Local Institution - 0042
  • Local Institution - 0041Recruiting
  • Local Institution - 0046
  • Local Institution - 0052Recruiting
  • Local Institution - 0190
  • Local Institution - 0075
  • Local Institution - 0181
  • Local Institution - 0185
  • Local Institution - 0187
  • Local Institution - 0191
  • Local Institution - 0125
  • Local Institution - 0066
  • Local Institution - 0186
  • Local Institution - 0048
  • Local Institution - 0163
  • Local Institution - 0162
  • Local Institution - 0126
  • Local Institution - 0160
  • Local Institution - 0114Recruiting
  • Local Institution - 0115
  • Local Institution - 0136
  • Local Institution - 0110Recruiting
  • Local Institution - 0070Recruiting
  • Local Institution - 0107Recruiting
  • Local Institution - 0029Recruiting
  • Local Institution - 0051Recruiting
  • Local Institution - 0080
  • Local Institution - 0037Recruiting
  • Local Institution - 0153
  • Local Institution - 0133Recruiting
  • Local Institution - 0023
  • Local Institution - 0137
  • Local Institution - 0044
  • Local Institution - 0021Recruiting
  • Local Institution - 0059
  • Local Institution - 0089Recruiting
  • Local Institution - 0129Recruiting
  • Local Institution - 0031Recruiting
  • Local Institution - 0071Recruiting
  • Local Institution - 0117Recruiting
  • Local Institution - 0028Recruiting
  • Local Institution - 0039
  • Local Institution - 0092
  • Local Institution - 0149
  • Local Institution - 0079Recruiting
  • Local Institution - 0025
  • Local Institution - 0045
  • Local Institution - 0116Recruiting
  • Local Institution - 0053Recruiting
  • Local Institution - 0043
  • Local Institution - 0132Recruiting
  • Local Institution - 0038
  • Local Institution - 0135Recruiting
  • Local Institution - 0049Recruiting
  • Local Institution - 0158Recruiting
  • Local Institution - 0174
  • Local Institution - 0056
  • Local Institution - 0100
  • Local Institution - 0058
  • Local Institution - 0093
  • Local Institution - 0170
  • Local Institution - 0086
  • Local Institution - 0057
  • Local Institution - 0055
  • Nouvel Hôpital Civil (NHC)Recruiting
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
  • Hôpitaux Universitaires Paris Sud - Hôpital BicêtreRecruiting
  • Local Institution - 0156
  • Local Institution - 0109Recruiting
  • Local Institution - 0113
  • Local Institution - 0176
  • Local Institution - 0195
  • Local Institution - 0146
  • Local Institution - 0151
  • Local Institution - 0120
  • Local Institution - 0061Recruiting
  • Local Institution - 0111Recruiting
  • Local Institution - 0067
  • Local Institution - 0119Recruiting
  • Local Institution - 0130
  • Local Institution - 0157
  • Local Institution - 0172
  • Local Institution - 0084
  • Local Institution - 0095
  • Local Institution - 0062
  • Local Institution - 0060
  • Local Institution - 0097
  • Local Institution - 0069Recruiting
  • Local Institution - 0072Recruiting
  • Local Institution - 0154
  • Local Institution - 0118
  • Local Institution - 0161
  • Local Institution - 0102Recruiting
  • Local Institution - 0101Recruiting
  • Local Institution - 0169
  • Local Institution - 0144
  • Local Institution - 0105
  • Local Institution - 0106
  • Local Institution - 0167
  • Local Institution - 0015
  • Local Institution - 0026
  • Local Institution - 0027
  • Local Institution - 0050
  • Local Institution - 0112
  • Local Institution - 0016
  • Local Institution - 0082
  • Local Institution - 0121
  • Local Institution - 0024
  • Local Institution - 0018
  • Local Institution - 0014
  • Local Institution - 0083
  • Local Institution - 0104
  • Local Institution - 0122
  • Local Institution - 0103
  • Local Institution - 0196
  • Local Institution - 0040Recruiting
  • Local Institution - 0034Recruiting
  • Local Institution - 0166
  • Local Institution - 0164
  • Local Institution - 0033
  • Local Institution - 0036Recruiting
  • Local Institution - 0030
  • Local Institution - 0035Recruiting
  • Local Institution - 0047Recruiting
  • Local Institution - 0073
  • GCM Medical Group, PSC - Hato Rey Site
  • Local Institution - 0148
  • Local Institution - 0076Recruiting
  • Local Institution - 0152
  • Local Institution - 0141Recruiting
  • Local Institution - 0142Recruiting
  • Local Institution - 0143Recruiting
  • Local Institution - 0094Recruiting
  • Local Institution - 0184
  • Local Institution - 0168
  • Local Institution - 0189

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1: Deucravacitinib

Arm 2: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response

Secondary Outcome Measures

Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Number of participants with adverse events (AEs)
Number of participants with serious adverse events (SAEs)
Number of participants with AEs leading to discontinuation of treatment
Number of participants with AEs leading to study discontinuation
Number of participants with target adverse events of special interest (AESIs)
Number of participants with laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with vital sign abnormalities

Full Information

First Posted
November 8, 2022
Last Updated
September 29, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05617677
Brief Title
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Acronym
POETYK SLE-1
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Systemic Lupus Erythematosus (SLE) (POETYK SLE-1)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 12, 2023 (Actual)
Primary Completion Date
December 17, 2025 (Anticipated)
Study Completion Date
December 17, 2027 (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 effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Autoimmune Diseases, Immune System Diseases, Connective Tissue Diseases, Immune-mediated Diseases, Active Systemic Lupus Erythematosus, Lupus, SLE, Deucravacitinib, Tyk2, POETYK, POETYK SLE

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Deucravacitinib
Arm Type
Experimental
Arm Title
Arm 2: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Deucravacitinib
Intervention Description
Specified dose on specified days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
Time Frame
At week 52
Secondary Outcome Measure Information:
Title
Proportion of participants who achieve British Isles Lupus Assessment Group-based Combined Lupus Assessment (BICLA) response
Time Frame
At week 52
Title
Proportion of participants who achieve both SRI(4) and BICLA (dual responders)
Time Frame
At week 52
Title
Proportion of participants with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score ≥ 10 at baseline who achieve a CLASI response, defined as a decrease of ≥ 50% from baseline CLASI activity score
Time Frame
At week 52
Title
Proportion of participants who achieve Lupus Low Disease Activity State (LLDAS)
Time Frame
At week 52
Title
Proportion of participants taking ≤ 7.5 mg/day prednisone (or equivalent) at Week 24 with no dose increase beyond protocol-specified limits
Time Frame
Up to 52 weeks
Title
Proportion of participants with ≥ 6 active (tender + swollen) joints at baseline who achieve at least 50% from baseline reduction in active (tender + swollen) joints
Time Frame
At week 52
Title
Change from baseline in patient-reported fatigue according to Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Time Frame
At week 52
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 156 weeks
Title
Number of participants with serious adverse events (SAEs)
Time Frame
Up to 156 weeks
Title
Number of participants with AEs leading to discontinuation of treatment
Time Frame
Up to 156 weeks
Title
Number of participants with AEs leading to study discontinuation
Time Frame
Up to 156 weeks
Title
Number of participants with target adverse events of special interest (AESIs)
Time Frame
Up to 156 weeks
Title
Number of participants with laboratory abnormalities
Time Frame
Up to 156 weeks
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 156 weeks
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 156 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Systemic Lupus Erythematosus (SLE) at least 24 weeks before the screening visit Meet the European Alliance of Associations for Rheumatology (EULAR)/American College of Rheumatology (ACR) 2019 classification criteria for SLE One of the following: positive antinuclear antibodies (ANA) ≥ 1:80 at screening OR positive anti dsDNA OR positive anti Smith (anti Sm) as determined by the central laboratory at screening Total Systemic Lupus Erythematosus Disease Activity Index-2K (SLEDAI-2K) score ≥ 6 points and clinical SLEDAI 2K score ≥ 4 points with joint involvement, and/or cutaneous vasculitis, and/or rash •Lupus headache, alopecia, organic brain syndrome, and mucosal ulcers must be recorded on SLEDAI 2K, if indicated, but do not count toward the points required for screening at entry At least one SLE background therapy(immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation Oral corticosteroid (OCS; prednisone or equivalent) background therapy is permitted but not required. For participants taking OCS, the dose must be stable for ≥ 2 weeks before the screening visit, cannot exceed 30 mg/day at screening, and must remain stable until the Week 4 visit. Participants can be on an OCS as well as an antimalarial and/or an immunosuppressant Exclusion Criteria: Diagnosis of drug-induced SLE rather than idiopathic SLE Other autoimmune diseases (eg, multiple sclerosis, psoriasis, inflammatory bowel disease, etc.) are excluded. Participants with type I autoimmune diabetes mellitus, thyroid autoimmune disease, Celiac disease, or secondary Sjögren's syndrome are not excluded SLE overlap syndromes including, but not limited to, rheumatoid arthritis, scleroderma, and mixed connective tissue disease are excluded Active or unstable lupus neuropsychiatric manifestations, including, but not limited to, any condition defined by BILAG A criteria Active, severe Class III, and IV, lupus nephritis that requires or may require treatment with cytotoxic agents or high-dose CS History of congenital or acquired immunodeficiency Known active infection, or any major episode of infection requiring hospitalization or treatment with parenteral (intramuscular or IV) antimicrobial agents (eg, antibiotics antiviral, antifungal, or antiparasitic agents) within 30 days of randomization, or treatment with oral antimicrobial agents within 2 weeks of randomization Currently on any therapy for chronic infection (eg, pneumocystis, herpes zoster, cytomegalovirus, invasive bacterial or fungal infections, or atypical mycobacteria) Taking more than 1 immunosuppressant at screening Other protocol-defined inclusion/exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
BMS Study Connect Contact Center www.BMSStudyConnect.com/SLE
Phone
855-907-3286
Email
Clinical.Trials@bms.com
First Name & Middle Initial & Last Name or Official Title & Degree
First line of the email MUST contain NCT # and Site #.
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
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Rubio, Site 0012
Facility Name
The University of Arizona Arthritis Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C Kwoh, Site 0193
Phone
520-626-4111
Facility Name
Kaiser Permanente
City
Fontana
State/Province
California
ZIP/Postal Code
92335
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Lee, Site 0178
Phone
818-634-5534
Facility Name
Private Practice - Dr. Chandrakant V. Mehta
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
Individual Site Status
Withdrawn
Facility Name
Arthritis & Osteoporosis Medical Center - La Palma
City
La Palma
State/Province
California
ZIP/Postal Code
90623
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Ho, Site 0090
Phone
562-867-8195
Facility Name
UCLA Clinical & Translational Research Center (CTRC)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen McMahon, Site 0124
Phone
310-467-2380
Facility Name
Private Practice - Dr. Hans Richard Barthel
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hans Barthel, Site 0128
Phone
805-969-2560
Facility Name
Denver Arthritis Clinic
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christopher Antolini, Site 0099
Phone
303-394-2828
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fotios Koumpouras, Site 0054
Phone
111-111-1111
Facility Name
Rheumatology Assoc. Of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Withdrawn
Facility Name
Nouvelle Clinical Research
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Withdrawn
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bubb, Site 0010
Phone
352-682-6390
Facility Name
University of Miami Hospital and Clinics, Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Carpintero, Site 0087
Phone
305-243-8567
Facility Name
Omega Research Group - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32808
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwabena Ayesu, Site 0007
Phone
386-668-4202
Facility Name
West Broward Rheumatology Associates
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elias Halpert, Site 0002
Phone
954-545-8401
Facility Name
Genesis Clinical Research, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Individual Site Status
Withdrawn
Facility Name
Baycare Medical Group
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Burnette, Site 0165
Phone
813-840-3600
Facility Name
North Georgia Rheumatology
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Theresa Lawrence Ford, Site 0147
Phone
111-111-1111
Facility Name
Greater Chicago Specialty Physicians
City
Schaumburg
State/Province
Illinois
ZIP/Postal Code
60195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamran Chaudhary, Site 0077
Phone
847-599-2492
Facility Name
Indiana University Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steven Hugenberg, Site 0108
Phone
317-274-8994
Facility Name
Lake Cumberland Rheumatology
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roneka Ravenell, Site 0188
Phone
502-351-6983
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Violeta Rus, Site 0192
Phone
410-706-3205
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alireza Meysami, Site 0006
Phone
313-622-4386
Facility Name
Saint Paul Rheumatology
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Withdrawn
Facility Name
Atlantic Health System Overlook Medical Center
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Kramer, Site 0177
Phone
646-734-2774
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noa Schwartz, Site 0159
Phone
347-640-2648
Facility Name
The Feinstein Institute for Medical Research
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meggan Mackay, Site 0180
Phone
516-562-3838
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amit Saxena, Site 0085
Phone
516-205-7051
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilana Abeles, Site 0098
Phone
585-273-2816
Facility Name
Carolinas HealthCare System SouthPark
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leslie Ranken, Site 0155
Phone
704-355-3162
Facility Name
STAT Research
City
Springboro
State/Province
Ohio
ZIP/Postal Code
45066
Country
United States
Individual Site Status
Withdrawn
Facility Name
Shelby Research LLC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramesh Gupta, Site 0003
Phone
901-681-9670
Facility Name
Arthritis & Rheumatology Research Institute
City
Allen
State/Province
Texas
ZIP/Postal Code
75013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megha Patel-Banker, Site 0064
Phone
516-859-2951
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-88520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Karp, Site 0065
Phone
214-850-7093
Facility Name
Dallas Fort Worth Clinical Research Associates - North Tarrant Parkway
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76177
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arshad Mustafa, Site 0088
Phone
817-722-6078
Facility Name
Advanced Rheumatology of Houston - Woodlands
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamar Brionez, Site 0005
Phone
936-681-4882
Facility Name
Carilion Clinic
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adegbenga Bankole, Site 0009
Phone
540-981-7700
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Mease, Site 0011
Phone
206-386-2000
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kwanghoon Han, Site 0139
Phone
206-849-5734
Facility Name
Aurora Rheumatology
City
Franklin
State/Province
Wisconsin
ZIP/Postal Code
53132
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvin Wells, Site 0063
Phone
414-916-0400
Facility Name
Local Institution - 0140
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
CP1280AEB
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0140
Facility Name
Local Institution - 0078
City
Quilmes
State/Province
Buenos Aires
ZIP/Postal Code
1878
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0078
Facility Name
Local Institution - 0013
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1121ABE
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0013
Facility Name
Local Institution - 0020
City
Caba
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
1406
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0020
Facility Name
Local Institution - 0123
City
San Miguel de Tucuman
State/Province
Tucumán
ZIP/Postal Code
4000
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0123
Facility Name
Local Institution - 0032
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0032
Facility Name
Local Institution - 0022
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0022
Facility Name
Local Institution - 0138
City
Córdoba
ZIP/Postal Code
5004
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0138
Facility Name
Local Institution - 0017
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0017
Facility Name
Local Institution - 0096
City
Lago sul
State/Province
Distrito Federal
ZIP/Postal Code
71635580
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0096
Facility Name
Local Institution - 0042
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-221
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0042
Facility Name
Local Institution - 0041
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0041
Facility Name
Local Institution - 0046
City
Juiz de Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0052
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80030110
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0052
Facility Name
Local Institution - 0190
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
80730-150
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0190
Facility Name
Local Institution - 0075
City
Niteroi
State/Province
Rio De Janeiro
ZIP/Postal Code
24020-096
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0181
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90610000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0181
Facility Name
Local Institution - 0185
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13015-001
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0185
Facility Name
Local Institution - 0187
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14051-140
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0187
Facility Name
Local Institution - 0191
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
04038-002
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0191
Facility Name
Local Institution - 0125
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
05403.900
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0125
Facility Name
Local Institution - 0066
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0066
Facility Name
Local Institution - 0186
City
Rio de Janeiro
ZIP/Postal Code
20551-030
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0186
Facility Name
Local Institution - 0048
City
São Paulo
ZIP/Postal Code
05652-900
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0163
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0163
Facility Name
Local Institution - 0162
City
Sofia
ZIP/Postal Code
1784
Country
Bulgaria
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0162
Facility Name
Local Institution - 0126
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0126
Facility Name
Local Institution - 0160
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0160
Facility Name
Local Institution - 0114
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0114
Facility Name
Local Institution - 0115
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0115
Facility Name
Local Institution - 0136
City
Rimouski
State/Province
Quebec
ZIP/Postal Code
G5L 5T1
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0136
Facility Name
Local Institution - 0110
City
Bengbu
State/Province
Anhui
ZIP/Postal Code
233004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0110
Facility Name
Local Institution - 0070
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0070
Facility Name
Local Institution - 0107
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0107
Facility Name
Local Institution - 0029
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0029
Facility Name
Local Institution - 0051
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0051
Facility Name
Local Institution - 0080
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0080
Facility Name
Local Institution - 0037
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0037
Facility Name
Local Institution - 0153
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0153
Facility Name
Local Institution - 0133
City
Luoyang
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0133
Facility Name
Local Institution - 0023
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0023
Facility Name
Local Institution - 0137
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0137
Facility Name
Local Institution - 0044
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0044
Facility Name
Local Institution - 0021
City
Zhuzhou
State/Province
Hunan
ZIP/Postal Code
412007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0021
Facility Name
Local Institution - 0059
City
Baotou
State/Province
Inner Mongolia
ZIP/Postal Code
014010
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0089
City
Hohhot
State/Province
Inner Mongolia
ZIP/Postal Code
010050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0089
Facility Name
Local Institution - 0129
City
Changzhou
State/Province
Jiangsu
ZIP/Postal Code
213003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0129
Facility Name
Local Institution - 0031
City
Jiujiang
State/Province
Jiangxi
ZIP/Postal Code
332000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0031
Facility Name
Local Institution - 0071
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0071
Facility Name
Local Institution - 0117
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0117
Facility Name
Local Institution - 0028
City
Pingxiang
State/Province
Jiangxi
ZIP/Postal Code
337055
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0028
Facility Name
Local Institution - 0039
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0039
Facility Name
Local Institution - 0092
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0092
Facility Name
Local Institution - 0149
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0149
Facility Name
Local Institution - 0079
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
0
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0079
Facility Name
Local Institution - 0025
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0045
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0045
Facility Name
Local Institution - 0116
City
Cheng Du
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0116
Facility Name
Local Institution - 0053
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0053
Facility Name
Local Institution - 0043
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0043
Facility Name
Local Institution - 0132
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0132
Facility Name
Local Institution - 0038
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0135
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0135
Facility Name
Local Institution - 0049
City
Shanghai
ZIP/Postal Code
200001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0049
Facility Name
Local Institution - 0158
City
Taiyuan
ZIP/Postal Code
030032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0158
Facility Name
Local Institution - 0174
City
Medellín
State/Province
Antioquia
ZIP/Postal Code
50021
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0174
Facility Name
Local Institution - 0056
City
Barranquilla
State/Province
Atlántico
ZIP/Postal Code
80002
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0056
Facility Name
Local Institution - 0100
City
Bogotá
State/Province
Distrito Capital De Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0100
Facility Name
Local Institution - 0058
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760035
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0093
City
Cali
State/Province
Valle Del Cauca
ZIP/Postal Code
760035
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0093
Facility Name
Local Institution - 0170
City
Bogotá
ZIP/Postal Code
110221
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0170
Facility Name
Local Institution - 0086
City
Bucaramanga
ZIP/Postal Code
680003
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0086
Facility Name
Local Institution - 0057
City
Chía
ZIP/Postal Code
250001
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0057
Facility Name
Local Institution - 0055
City
Medellin
ZIP/Postal Code
50036
Country
Colombia
Individual Site Status
Withdrawn
Facility Name
Nouvel Hôpital Civil (NHC)
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Sophie KORGANOW, Site 0150
Phone
+330369550521
Facility Name
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
City
Nantes
State/Province
Loire-Atlantique
ZIP/Postal Code
44093 Cedex 1
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine Enfrein, Site 0068
Phone
0625883158
Facility Name
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xavier mariette, Site 0173
Phone
33 1 45213758
Facility Name
Local Institution - 0156
City
Tours
ZIP/Postal Code
37032
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0156
Facility Name
Local Institution - 0109
City
Tübingen
State/Province
Baden-Württemberg
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0109
Facility Name
Local Institution - 0113
City
Bad Abbach
State/Province
Bayern
ZIP/Postal Code
93077
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0176
City
München
State/Province
Bayern
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0176
Facility Name
Local Institution - 0195
City
Chemnitz
State/Province
Sachsen
ZIP/Postal Code
09117
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0195
Facility Name
Local Institution - 0146
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0146
Facility Name
Local Institution - 0151
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0151
Facility Name
Local Institution - 0120
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0120
Facility Name
Local Institution - 0061
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0061
Facility Name
Local Institution - 0111
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0111
Facility Name
Local Institution - 0067
City
Tuen Mun
ZIP/Postal Code
999077
Country
Hong Kong
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0067
Facility Name
Local Institution - 0119
City
Manorhamilton
State/Province
Leitrim
ZIP/Postal Code
0
Country
Ireland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0119
Facility Name
Local Institution - 0130
City
Cork
ZIP/Postal Code
T12 E8YV
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0130
Facility Name
Local Institution - 0157
City
Dublin
ZIP/Postal Code
D08 E9P6
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0157
Facility Name
Local Institution - 0172
City
Dublin
ZIP/Postal Code
D15 X40D
Country
Ireland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0172
Facility Name
Local Institution - 0084
City
Roma
State/Province
Lazio
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0084
Facility Name
Local Institution - 0095
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0095
Facility Name
Local Institution - 0062
City
Milan
State/Province
Milano
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0060
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0060
Facility Name
Local Institution - 0097
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0097
Facility Name
Local Institution - 0069
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0069
Facility Name
Local Institution - 0072
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0072
Facility Name
Local Institution - 0154
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0154
Facility Name
Local Institution - 0118
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0161
City
Verona
ZIP/Postal Code
37134
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0161
Facility Name
Local Institution - 0102
City
Gwangju-si
State/Province
Kwangju-Kwangyǒkshi
ZIP/Postal Code
61469
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0102
Facility Name
Local Institution - 0101
City
Suwon
State/Province
Kyǒnggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0101
Facility Name
Local Institution - 0169
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0169
Facility Name
Local Institution - 0144
City
Seoul
State/Province
Seoul-teukbyeolsi [Seoul]
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0144
Facility Name
Local Institution - 0105
City
Jung-gu
State/Province
Taegu-Kwangyǒkshi
ZIP/Postal Code
41944
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0106
City
Jung-gu
State/Province
Taejǒn-Kwangyǒkshi
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0167
City
Kaunas
State/Province
Kauno Apskritis
ZIP/Postal Code
LT-50161
Country
Lithuania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0167
Facility Name
Local Institution - 0015
City
Mexicali
State/Province
Baja California
ZIP/Postal Code
21100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0015
Facility Name
Local Institution - 0026
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
01120
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0026
Facility Name
Local Institution - 0027
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
03720
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0027
Facility Name
Local Institution - 0050
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0050
Facility Name
Local Institution - 0112
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
14080
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0112
Facility Name
Local Institution - 0016
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0016
Facility Name
Local Institution - 0082
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0082
Facility Name
Local Institution - 0121
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0121
Facility Name
Local Institution - 0024
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45116
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0024
Facility Name
Local Institution - 0018
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0018
Facility Name
Local Institution - 0014
City
Mexico City
ZIP/Postal Code
6760
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0083
City
Puebla
ZIP/Postal Code
72160
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0083
Facility Name
Local Institution - 0104
City
Lima
ZIP/Postal Code
15046
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0104
Facility Name
Local Institution - 0122
City
Lima
ZIP/Postal Code
15047
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0122
Facility Name
Local Institution - 0103
City
Lima
ZIP/Postal Code
33
Country
Peru
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0103
Facility Name
Local Institution - 0196
City
Wroclaw
State/Province
Dolnośląskie
ZIP/Postal Code
50-381
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0196
Facility Name
Local Institution - 0040
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0040
Facility Name
Local Institution - 0034
City
Nadarzyn
State/Province
Mazowieckie
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0034
Facility Name
Local Institution - 0166
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-637
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0166
Facility Name
Local Institution - 0164
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0164
Facility Name
Local Institution - 0033
City
Krakow
State/Province
Małopolskie
ZIP/Postal Code
30-363
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0033
Facility Name
Local Institution - 0036
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-218
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0036
Facility Name
Local Institution - 0030
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-446
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Local Institution - 0035
City
Bialystok
ZIP/Postal Code
15-707
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0035
Facility Name
Local Institution - 0047
City
Katowice
State/Province
Śląskie
ZIP/Postal Code
40-081
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0047
Facility Name
Local Institution - 0073
City
Lisbon
ZIP/Postal Code
2720-276
Country
Portugal
Individual Site Status
Withdrawn
Facility Name
GCM Medical Group, PSC - Hato Rey Site
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gregorio Cortes-Maisonet, Site 0197
Phone
787-936-2100
Facility Name
Local Institution - 0148
City
Bucharest
State/Province
București
ZIP/Postal Code
011053
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0148
Facility Name
Local Institution - 0076
City
Bucharest
State/Province
București
ZIP/Postal Code
011172
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0076
Facility Name
Local Institution - 0152
City
Bucharest
State/Province
București
ZIP/Postal Code
014142
Country
Romania
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0152
Facility Name
Local Institution - 0141
City
Bucuresti
State/Province
București
ZIP/Postal Code
020125
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0141
Facility Name
Local Institution - 0142
City
Craiova
State/Province
Dolj
ZIP/Postal Code
200347
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0142
Facility Name
Local Institution - 0143
City
Timişoara
State/Province
Timiș
ZIP/Postal Code
0
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0143
Facility Name
Local Institution - 0094
City
Râmnicu Vâlcea
ZIP/Postal Code
240762
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0094
Facility Name
Local Institution - 0184
City
Ankara
ZIP/Postal Code
06560
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0184
Facility Name
Local Institution - 0168
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0168
Facility Name
Local Institution - 0189
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site 0189

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/disclosurecommitment.html
IPD Sharing Time Frame
See Plan Description
IPD Sharing Access Criteria
See Plan Description
IPD Sharing URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.BMSStudyConnect.com/SLE
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)

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