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Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

Primary Purpose

Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
branebrutinib
abatacept
branebrutinib placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Disorder

Eligibility Criteria

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

Inclusion Criteria:

Sub-study for Systemic Lupus Erythematosus (SLE)

  • Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification
  • Diagnosed with SLE more than 24 weeks before screening visit

Sub-study for primary Sjögren's Syndrome (pSS)

  • Moderate to severe pSS, meeting ACR-EULAR classification criteria

Sub-study for active Rheumatoid Arthritis (RA)

  • Moderate to severe adult-onset RA
  • ACR global functional status class I to III

Women and men must agree to follow instructions for methods of contraception.

Exclusion Criteria:

Sub-study for SLE

  • Certain other autoimmune diseases and overlap syndromes

Sub-study for pSS

  • Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions

Sub-study for RA

  • Diagnosis with juvenile arthritis or idiopathic arthritis before age 16

For all sub-studies:

  • History of any significant drug allergy
  • Active infection, significant concurrent medical condition, or clinically significant abnormalities

Other protocol defined inclusion/exclusion criteria could apply

Sites / Locations

  • Arizona Arthritis and Rheumatology Research
  • Medvin Clinical Research - Covina Office
  • Local Institution - 0024
  • TriWest Research Associates
  • Inland Rheumatology and Osteoporosis Medical Group
  • Local Institution
  • Omega Research Consultants - DeBary
  • Local Institution - 0035
  • Local Institution
  • Integral Rheumatology & Immunology Specialists
  • North Georgia Rheumatology Group-Lawrenceville
  • Clinical Investigation Specialists - Gurnee
  • Local Institution
  • Arthritis and Diabetes Clinic
  • University of Michigan Medical Center
  • AA Medical Research Center-Grand Blanc
  • West County Rheumatology
  • Arthritis Consultants
  • Arthritis Center of Nebraska
  • Innovative Health Research
  • Local Institution
  • Local Institution
  • Local Institution - 0008
  • Pmg Research Of Salisbury
  • Local Institution
  • Health Research of Oklahoma
  • Local Institution - 0022
  • Altoona Center for Clinical Research
  • Arthritis and Osteoporosis Center - Orangeburg
  • Low Country Rheumatology
  • West Tennessee Research Institute
  • Office of Ramesh C. Gupta, MD
  • Local Institution - 0092
  • Local Institution
  • Local Institution - 0063
  • Southwest Rheumatology Research
  • Trinity Universal Research
  • Sun Research Institute
  • Local Institution
  • Arthritis Northwest
  • Local Institution - 0065
  • Local Institution - 0047
  • Local Institution - 0066
  • Local Institution - 0064
  • Local Institution - 0069
  • Local Institution - 0075
  • Hopital Europeen Marseille
  • Hopital Lapeyronie
  • Local Institution - 0038
  • Local Institution - 0049
  • Rheumazentrum Ruhrgebiet
  • Uniklinik Koln
  • Local Institution - 0051
  • Centro Integral de Reumatologia
  • Clinica de Investigacion en Reumatologia y Obesidad
  • Local Institution - 0113
  • Local Institution - 0102
  • Local Institution - 0104
  • Local Institution - 0114
  • Local Institution - 0050
  • Local Institution - 0059
  • Universitair Medisch Centrum Groningen
  • Local Institution - 0094
  • Local Institution - 0089
  • Local Institution - 0072
  • Local Institution - 0012
  • Local Institution - 0073
  • Local Institution - 0011
  • Local Institution - 0091
  • Local Institution - 0017
  • Local Institution - 0033
  • Local Institution - 0101
  • Local Institution - 0026
  • Local Institution - 0028
  • Local Institution - 0036
  • Local Institution - 0025
  • Local Institution - 0018
  • Local Institution - 0061
  • The Leeds Teaching Hospitals NHS Trust
  • Guys and Saint Thomas NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Systemic Lupus Erythematosus (SLE): branebrutinib

SLE: placebo

Primary Sjögren's Syndrome (pSS): branebrutinib

pSS: placebo

Rheumatoid Arthritis (RA): branebrutinib followed by abatacept

RA: placebo followed by abatacept

Arm Description

Outcomes

Primary Outcome Measures

Systemic lupus erythematosus (SLE): Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) activity score response
Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
pSS: Proportion of participants with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker
Rheumatoid arthritis (RA): ACR50 response
Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)

Secondary Outcome Measures

SLE: SLEDAI-2K score response
Change from baseline in SLEDAI-2K score (Systemic Lupus Erythematosus Disease Activity Index 2000)
SLE: BILAG-based Composite Lupus Assessment response
Change from baseline in BILAG-based (British Isles Lupus Assessment Group) Composite Lupus Assessment response
RA: DAS28-CRP response
Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)
RA: DAS28-ESR response
Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)
RA: SDAI response
Change from baseline in SDAI (Simplified Disease Activity Index)
RA: CDAI response
Change from baseline in CDAI (Clinical Disease Activity Index)
RA: ACR20 response
Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)
RA: ACR70 response
Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
Number of participants with adverse events (AEs)
Number of participants with clinical laboratory abnormalities
Number of participants with vital sign abnormalities
Number of participants with electrocardiogram (ECG) abnormalities

Full Information

First Posted
November 28, 2019
Last Updated
December 16, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT04186871
Brief Title
Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis
Official Title
A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2022 (Actual)

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 effectiveness of treatment with branebrutinib treatment in participants with active systemic Lupus Erythematosus (SLE) or Primary Sjögren's Syndrome (pSS), or branebrutinib treatment followed by open-label abatacept treatment in study participants with active Rheumatoid Arthritis (RA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Disorder, Rheumatoid Arthritis, Systemic Lupus Erythematosus, Primary Sjögren's Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
double-blind
Allocation
Randomized
Enrollment
112 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Systemic Lupus Erythematosus (SLE): branebrutinib
Arm Type
Experimental
Arm Title
SLE: placebo
Arm Type
Placebo Comparator
Arm Title
Primary Sjögren's Syndrome (pSS): branebrutinib
Arm Type
Experimental
Arm Title
pSS: placebo
Arm Type
Placebo Comparator
Arm Title
Rheumatoid Arthritis (RA): branebrutinib followed by abatacept
Arm Type
Experimental
Arm Title
RA: placebo followed by abatacept
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
branebrutinib
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
abatacept
Intervention Description
Specified dose on specified days
Intervention Type
Drug
Intervention Name(s)
branebrutinib placebo
Intervention Description
Specified dose on specified days
Primary Outcome Measure Information:
Title
Systemic lupus erythematosus (SLE): Modified Cutaneous Lupus Erythematosus Disease Area and Severity Index (mCLASI) activity score response
Description
Proportion of participants with a ≥ 50% reduction of mCLASI from baseline
Time Frame
at 24 weeks
Title
pSS: Proportion of participants with changes in a composite score that includes ESSPRI (EULAR Sjögren's Syndrome Patient Reported Index), ESSDAI (EULAR Sjögren's Syndrome Disease Activity Index), ocular staining, salivary flow and serological marker
Time Frame
at 24 weeks
Title
Rheumatoid arthritis (RA): ACR50 response
Description
Proportion of participants achieving ACR50 response (American College of Rheumatology 50 criteria)
Time Frame
at 12 weeks
Secondary Outcome Measure Information:
Title
SLE: SLEDAI-2K score response
Description
Change from baseline in SLEDAI-2K score (Systemic Lupus Erythematosus Disease Activity Index 2000)
Time Frame
at 24 weeks
Title
SLE: BILAG-based Composite Lupus Assessment response
Description
Change from baseline in BILAG-based (British Isles Lupus Assessment Group) Composite Lupus Assessment response
Time Frame
at 24 weeks
Title
RA: DAS28-CRP response
Description
Change from baseline in DAS28-CRP (Disease Activity Score 28 - C reactive protein)
Time Frame
at 12 weeks
Title
RA: DAS28-ESR response
Description
Change from baseline in DAS28-ESR (Disease Activity Score 28 - Erythrocyte Sedimentation Rate)
Time Frame
at 12 weeks
Title
RA: SDAI response
Description
Change from baseline in SDAI (Simplified Disease Activity Index)
Time Frame
at 12 weeks
Title
RA: CDAI response
Description
Change from baseline in CDAI (Clinical Disease Activity Index)
Time Frame
at 12 weeks
Title
RA: ACR20 response
Description
Proportion of participants achieving ACR20 response (American College of Rheumatology 20 criteria)
Time Frame
at 12 weeks
Title
RA: ACR70 response
Description
Proportion of participants achieving ACR70 response (American College of Rheumatology 70 criteria)
Time Frame
at 12 weeks
Title
Number of participants with adverse events (AEs)
Time Frame
Up to 32 weeks
Title
Number of participants with clinical laboratory abnormalities
Time Frame
Up to 32 weeks
Title
Number of participants with vital sign abnormalities
Time Frame
Up to 32 weeks
Title
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame
Up to 32 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: Sub-study for Systemic Lupus Erythematosus (SLE) Active SLE as defined by the Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) classification Diagnosed with SLE more than 24 weeks before screening visit Sub-study for primary Sjögren's Syndrome (pSS) Moderate to severe pSS, meeting ACR-EULAR classification criteria Sub-study for active Rheumatoid Arthritis (RA) Moderate to severe adult-onset RA ACR global functional status class I to III Women and men must agree to follow instructions for methods of contraception. Exclusion Criteria: Sub-study for SLE Certain other autoimmune diseases and overlap syndromes Sub-study for pSS Certain other immune-mediated diseases, active fibromyalgia, or other medical conditions Sub-study for RA Diagnosis with juvenile arthritis or idiopathic arthritis before age 16 For all sub-studies: History of any significant drug allergy Active infection, significant concurrent medical condition, or clinically significant abnormalities Other protocol defined inclusion/exclusion criteria could 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
Arizona Arthritis and Rheumatology Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Medvin Clinical Research - Covina Office
City
Covina
State/Province
California
ZIP/Postal Code
91723
Country
United States
Facility Name
Local Institution - 0024
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
TriWest Research Associates
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Inland Rheumatology and Osteoporosis Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Local Institution
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Omega Research Consultants - DeBary
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Facility Name
Local Institution - 0035
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Local Institution
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
North Georgia Rheumatology Group-Lawrenceville
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Clinical Investigation Specialists - Gurnee
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Local Institution
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47715
Country
United States
Facility Name
Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
AA Medical Research Center-Grand Blanc
City
Grand Blanc
State/Province
Michigan
ZIP/Postal Code
48439
Country
United States
Facility Name
West County Rheumatology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Arthritis Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Arthritis Center of Nebraska
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Innovative Health Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Local Institution
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0008
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Pmg Research Of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Local Institution
City
Minot
State/Province
North Dakota
ZIP/Postal Code
58701
Country
United States
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103-2433
Country
United States
Facility Name
Local Institution - 0022
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
79112
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Arthritis and Osteoporosis Center - Orangeburg
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Low Country Rheumatology
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Office of Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Local Institution - 0092
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Facility Name
Local Institution
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Local Institution - 0063
City
Houston
State/Province
Texas
ZIP/Postal Code
77084
Country
United States
Facility Name
Southwest Rheumatology Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Trinity Universal Research
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Sun Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Local Institution
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Local Institution - 0065
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Local Institution - 0047
City
San Miguel De Tucum
State/Province
Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Local Institution - 0066
City
San Juan
ZIP/Postal Code
5402
Country
Argentina
Facility Name
Local Institution - 0064
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution - 0069
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution - 0075
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Hopital Europeen Marseille
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Hopital Lapeyronie
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution - 0038
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution - 0049
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Uniklinik Koln
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Local Institution - 0051
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Centro Integral de Reumatologia
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Facility Name
Clinica de Investigacion en Reumatologia y Obesidad
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Local Institution - 0113
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45070
Country
Mexico
Facility Name
Local Institution - 0102
City
Cuernavaca
State/Province
Morelos
ZIP/Postal Code
62290
Country
Mexico
Facility Name
Local Institution - 0104
City
Merida
State/Province
Yucatan
ZIP/Postal Code
97000
Country
Mexico
Facility Name
Local Institution - 0114
City
San Luis Potosi
ZIP/Postal Code
78200
Country
Mexico
Facility Name
Local Institution - 0050
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution - 0059
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico
Facility Name
Universitair Medisch Centrum Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution - 0094
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Local Institution - 0089
City
Bydgoszcz
ZIP/Postal Code
85-065
Country
Poland
Facility Name
Local Institution - 0072
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution - 0012
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution - 0073
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Local Institution - 0011
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Local Institution - 0091
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Local Institution - 0017
City
Warszawa
ZIP/Postal Code
00-660
Country
Poland
Facility Name
Local Institution - 0033
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Local Institution - 0101
City
Warszawa
ZIP/Postal Code
02-793
Country
Poland
Facility Name
Local Institution - 0026
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Local Institution - 0028
City
A Coru
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution - 0036
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0025
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0018
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Local Institution - 0061
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
The Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Guys and Saint Thomas NHS Foundation Trust
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
University Hospital Southampton NHS Foundation Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
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

Learn more about this trial

Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis

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