Back to resultsEffects of Abatacept in Patients With Early Rheumatoid Arthritis (AVERT-2)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept
Methotrexate
Abatacept Placebo
Methotrexate Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Rheumatoid arthritis (RA) diagnosis less than 6 months
- CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
- At least 3 swollen and 3 tender joints
- Anti-citrullinated protein antibodies (ACPA) positive
Exclusion Criteria:
- At risk for tuberculosis
- Have acute infection
- Have chronic or recurrent bacterial or serious latent viral infection
- History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
- Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)
Sites / Locations
- Rheumatology Associates Of North Alabama, P.C.
- Arizona Arthritis & Rheumatology Research PLLC
- Arizona Arthritis & Rheumatology Research PLLC
- Arizona Arthritis & Rheumatology Research PLLC
- Arizona Arthritis & Rheumatology Research PLLC
- Arizona Arthritis & Rheumatology Research PLLC
- CHI St. Vincent Medical Group Hot Springs
- Arkansas Primary Care Clinic
- St. Joseph Heritage Medical Group
- Healthcare Partners Medical Group
- Valerius Medical Group and Research Center
- Inland Rheumatology Clinical Trials Inc.
- Joao Nascimento
- Rheumatology Associates Of Central Florida, P.A.
- Tampa Medical Group, Pa
- Coeur D'Alene Arthrit Clin
- Arthritis And Diabetes Clinic
- Klein And Associates, M.D., Pa
- St. Paul Rheumatology, P.A.
- Arthritis Consultants
- Physician Research Collaboration, Llc
- Arthritis And Osteoporosis Associates, Pa
- Physicians Research Center, Llc
- Albuquerque Center For Rheumatology
- Albuquerque Clinical Trials
- Hospital For Special Surgery
- Local Institution
- Pmg Research Of Salisbury
- Carolina Arthritis Associates
- Pmg Research Of Wilmington Llc
- Health Research Of Oklahoma
- Oklahoma Ctr For Arthritis Therapy And Research, Inc.
- Altoona Center For Clinical Research
- The Arthritis Group
- Clinical Research Center Of Reading, Llp
- West Tennessee Research Institute
- Metroplex Clinical Research Center
- Houston Institute For Clinical Research
- Arthritis Clinic Of Northern Virginia, P.C.
- Spectrum Medical, Inc.
- Arthritis Northwest
- Rheumatic Disease Center
- Organizacion Medica De Investigacion S.A. (Omi)
- Local Institution
- Hospital General De Agudos J.M. Ramos Mejia
- Framingham Centro Medico
- Instituto de Asistencia Reumatologica Integral
- Caici
- Instituto De Rehabilitacion Psicofisica
- Centro Consultora Integral de Salud SRL
- Hospital Privado-Centro Medico De Cordoba S.A.
- Centro De Investigaciones Reumatologicas
- Centro Medico Privado De Reumatologia
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Rheuma Zentrum Favoriten
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Centre De Recherche Musculo-Squelettique
- Local Institution
- Centro Medico de Reumatologia Limitada
- Centro De Estudios Reumatologicos
- Someal
- Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
- Fundacion Instituto de Reumatologia Fernando Chalem
- Clinica de Artritis Temprana
- Hospital Pablo Tobon Uribe
- Oddeleni klinicke farmakologie
- Revmatologicky ustav
- MEDICAL PLUS, s.r.o.
- PV Medical Services, s.r.o.
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Rheumapraxis Dr. Kurthen
- Charite Campus Mitte
- Rheumatologische Schwerpunktpraxis Dr. Zinke
- Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
- Schlosspark-Klinik
- Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
- Klinikum Der Albrecht-Ludwigs-Universitat
- MVZ Rheuma
- Hamburger Rheuma Forschungszentrum
- Gemeinschaftspraxis Drs. von Hinueber u Demary
- Rheumatologie In Wuermtal
- Praxis Dr. Walter
- Local Institution
- Belgyogy. Int. Reuma. DEOEC
- Vaszary Kolos Hospital
- Reumatologiai Osztaly Flor F.
- Reumatologiai Osztaly MAV
- Vital Medical Center
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Ospedale Vittorio Emanuele
- Istituto Gaetano Pini
- Azienda Ospedaliera Luigi Sacco
- Local Institution
- Local Institution
- Ospedale Borgo Roma
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Acq Medic Sac
- Clinica El Golf
- Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
- Nszoz Unica Cr
- Nzoz Mak Med
- SANUS Szpital Specjalistyczny Sp. z o.o.
- Local Institution
- Slaski Szpital Reumatologiczno - Rehabilitacyjny
- Instytut Reumatologii, I Klinika Reumatologii
- Centrum Medyczne AMED Sp. z o.o.
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
Combination Therapy: Abatacept + Methotrexate
Methotrexate treatment
Abatacept Placebo
Methotrexate Placebo
Arm Description
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Methotrexate at least 15mg per week tablet or capsule orally
Placebo for Abatacept subcutaneous injection once per week
Placebo to match Methotrexate capsule orally once per week
Outcomes
Primary Outcome Measures
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3.
Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
Secondary Outcome Measures
Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
Percentage of Participants in SDAI Remission at Week 52
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52
The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
Percentage of Participants in Boolean Remission at Week 52
Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02504268
Brief Title
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
Acronym
AVERT-2
Official Title
A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2015 (Actual)
Primary Completion Date
January 16, 2017 (Actual)
Study Completion Date
March 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.
Detailed Description
Subcutaneous (SC)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
994 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Combination Therapy: Abatacept + Methotrexate
Arm Type
Experimental
Arm Description
Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week
Arm Title
Methotrexate treatment
Arm Type
Active Comparator
Arm Description
Methotrexate at least 15mg per week tablet or capsule orally
Arm Title
Abatacept Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Abatacept subcutaneous injection once per week
Arm Title
Methotrexate Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to match Methotrexate capsule orally once per week
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Type
Other
Intervention Name(s)
Abatacept Placebo
Intervention Type
Other
Intervention Name(s)
Methotrexate Placebo
Primary Outcome Measure Information:
Title
Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
Description
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3.
Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
Description
DAS28-CRP = Disease Activity Score 28 based on C-reactive protein DAS28-CRP Remission is defined as DAS28-CRP <= 2.6 Using a logistic regression model that includes treatment arm, stratification variable and baseline measure as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided.
Time Frame
Week 24
Title
Percentage of Participants in SDAI Remission at Week 52
Description
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI <= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI <= 3.3 indicates disease remission and SDAI >26 = high disease activity.
Time Frame
Week 52
Title
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52
Description
The Modified Total Sharp Score (mTSS) is calculated as the bilateral sum of erosion and Joint Space Narrowing (JSN) scores across all joints of the hands and feet.The score range for mTSS is 0-448. Higher scores indicate more joint damage. The mean change from baseline in TSS using modified Sharp/van der Heijide scores was assessed using a rank-based nonparametric ANCOVA model.
Time Frame
Week 52
Title
Percentage of Participants in Boolean Remission at Week 52
Description
Boolean Remission is defined as Tender joint count less than 1, Swollen joint count less than 1, CRP less than 1 mg/dL, patient global assessment less than 1 (on 0 to 10 VAS scale). Logistic regression was used for this endpoint.
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Rheumatoid arthritis (RA) diagnosis less than 6 months
CRP > 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
At least 3 swollen and 3 tender joints
Anti-citrullinated protein antibodies (ACPA) positive
Exclusion Criteria:
At risk for tuberculosis
Have acute infection
Have chronic or recurrent bacterial or serious latent viral infection
History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)
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
Rheumatology Associates Of North Alabama, P.C.
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
CHI St. Vincent Medical Group Hot Springs
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Arkansas Primary Care Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72204
Country
United States
Facility Name
St. Joseph Heritage Medical Group
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Healthcare Partners Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92646
Country
United States
Facility Name
Valerius Medical Group and Research Center
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Inland Rheumatology Clinical Trials Inc.
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Joao Nascimento
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
Rheumatology Associates Of Central Florida, P.A.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Tampa Medical Group, Pa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Coeur D'Alene Arthrit Clin
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Arthritis And Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Facility Name
Klein And Associates, M.D., Pa
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
St. Paul Rheumatology, P.A.
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Facility Name
Arthritis Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Physician Research Collaboration, Llc
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
Arthritis And Osteoporosis Associates, Pa
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Physicians Research Center, Llc
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Center For Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albuquerque Clinical Trials
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Hospital For Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021-4892
Country
United States
Facility Name
Local Institution
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Pmg Research Of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Carolina Arthritis Associates
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Pmg Research Of Wilmington Llc
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Health Research Of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Oklahoma Ctr For Arthritis Therapy And Research, Inc.
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Altoona Center For Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
The Arthritis Group
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
Facility Name
Clinical Research Center Of Reading, Llp
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Houston Institute For Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Arthritis Clinic Of Northern Virginia, P.C.
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Spectrum Medical, Inc.
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Arthritis Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Rheumatic Disease Center
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
Facility Name
Organizacion Medica De Investigacion S.A. (Omi)
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1015
Country
Argentina
Facility Name
Local Institution
City
Ciudad Autonoma Beunos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1431
Country
Argentina
Facility Name
Hospital General De Agudos J.M. Ramos Mejia
City
Ciudad Autonoma De Buenos Aire
State/Province
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Framingham Centro Medico
City
La Plata
State/Province
Buenos Aires
ZIP/Postal Code
1902
Country
Argentina
Facility Name
Instituto de Asistencia Reumatologica Integral
City
San Fernando
State/Province
Buenos Aires
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Caici
City
Rosario
State/Province
Santa FE
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Instituto De Rehabilitacion Psicofisica
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Facility Name
Centro Consultora Integral de Salud SRL
City
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Hospital Privado-Centro Medico De Cordoba S.A.
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Centro De Investigaciones Reumatologicas
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Centro Medico Privado De Reumatologia
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Local Institution
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Local Institution
City
Southport
State/Province
Queensland
ZIP/Postal Code
4215
Country
Australia
Facility Name
Local Institution
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Local Institution
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Facility Name
Local Institution
City
Coffs Harbour
ZIP/Postal Code
2450
Country
Australia
Facility Name
Rheuma Zentrum Favoriten
City
Wien
ZIP/Postal Code
1100
Country
Austria
Facility Name
Local Institution
City
Juiz De Fora
State/Province
Minas Gerais
ZIP/Postal Code
36010-570
Country
Brazil
Facility Name
Local Institution
City
Varginha
State/Province
Minas Gerais
ZIP/Postal Code
37006-710
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80030-110
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90480-000
Country
Brazil
Facility Name
Local Institution
City
Santo Andre
State/Province
SAO Paulo
ZIP/Postal Code
09060-870
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04032-060
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04266-010
Country
Brazil
Facility Name
Local Institution
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
Facility Name
Local Institution
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Centre De Recherche Musculo-Squelettique
City
Trois-rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Local Institution
City
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Centro Medico de Reumatologia Limitada
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4790928
Country
Chile
Facility Name
Centro De Estudios Reumatologicos
City
Santiago De Chile
State/Province
Metropolitana
ZIP/Postal Code
7501126
Country
Chile
Facility Name
Someal
City
Santiago
State/Province
Metropolitana
ZIP/Postal Code
7510586
Country
Chile
Facility Name
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
City
Bogota
Country
Colombia
Facility Name
Fundacion Instituto de Reumatologia Fernando Chalem
City
Bogota
Country
Colombia
Facility Name
Clinica de Artritis Temprana
City
Cali
Country
Colombia
Facility Name
Hospital Pablo Tobon Uribe
City
Medellin
ZIP/Postal Code
MEDELLIN
Country
Colombia
Facility Name
Oddeleni klinicke farmakologie
City
Plzen-Bory
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
MEDICAL PLUS, s.r.o.
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
PV Medical Services, s.r.o.
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Local Institution
City
Hyvinkaa
ZIP/Postal Code
05800
Country
Finland
Facility Name
Local Institution
City
Kuopio
ZIP/Postal Code
70110
Country
Finland
Facility Name
Local Institution
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Local Institution
City
Orleans cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Local Institution
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Local Institution
City
Toulouse cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Rheumapraxis Dr. Kurthen
City
Aachen
ZIP/Postal Code
52064
Country
Germany
Facility Name
Charite Campus Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rheumatologische Schwerpunktpraxis Dr. Zinke
City
Berlin
ZIP/Postal Code
13055
Country
Germany
Facility Name
Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Schlosspark-Klinik
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
City
Burghausen
ZIP/Postal Code
84489
Country
Germany
Facility Name
Klinikum Der Albrecht-Ludwigs-Universitat
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
MVZ Rheuma
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Hamburger Rheuma Forschungszentrum
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Gemeinschaftspraxis Drs. von Hinueber u Demary
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
Facility Name
Rheumatologie In Wuermtal
City
Planegg
ZIP/Postal Code
82152
Country
Germany
Facility Name
Praxis Dr. Walter
City
Rendsburg
ZIP/Postal Code
24768
Country
Germany
Facility Name
Local Institution
City
Budapest
ZIP/Postal Code
1027
Country
Hungary
Facility Name
Belgyogy. Int. Reuma. DEOEC
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Vaszary Kolos Hospital
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Reumatologiai Osztaly Flor F.
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Facility Name
Reumatologiai Osztaly MAV
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Vital Medical Center
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Local Institution
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Local Institution
City
Ramat-gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Tel Hashomer
ZIP/Postal Code
52620
Country
Israel
Facility Name
Local Institution
City
Zrifin
Country
Israel
Facility Name
Ospedale Vittorio Emanuele
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Istituto Gaetano Pini
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Azienda Ospedaliera Luigi Sacco
City
Milano
ZIP/Postal Code
20154
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ospedale Borgo Roma
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4578511
Country
Japan
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4668560
Country
Japan
Facility Name
Local Institution
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
8108563
Country
Japan
Facility Name
Local Institution
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8078556
Country
Japan
Facility Name
Local Institution
City
Hiroshima-Shi
State/Province
Hiroshima
ZIP/Postal Code
7348551
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608604
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0608648
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0630811
Country
Japan
Facility Name
Local Institution
City
Kato-shi
State/Province
Hyogo
ZIP/Postal Code
6731462
Country
Japan
Facility Name
Local Institution
City
Hitachinaka-shi
State/Province
Ibaraki
ZIP/Postal Code
3120057
Country
Japan
Facility Name
Local Institution
City
Mito-shi
State/Province
Ibaraki
ZIP/Postal Code
3100015
Country
Japan
Facility Name
Local Institution
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
8900063
Country
Japan
Facility Name
Local Institution
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
2520392
Country
Japan
Facility Name
Local Institution
City
Isahaya-shi
State/Province
Nagasaki
ZIP/Postal Code
8548501
Country
Japan
Facility Name
Local Institution
City
Sasebo-shi
State/Province
Nagasaki
ZIP/Postal Code
8571195
Country
Japan
Facility Name
Local Institution
City
Tomigusuku-shi
State/Province
Okinawa
ZIP/Postal Code
9010224
Country
Japan
Facility Name
Local Institution
City
Izumisano-shi
State/Province
Osaka
ZIP/Postal Code
5988577
Country
Japan
Facility Name
Local Institution
City
Kawachinagano
State/Province
Osaka
ZIP/Postal Code
5868521
Country
Japan
Facility Name
Local Institution
City
Iruma-gun
State/Province
Saitama
ZIP/Postal Code
3500495
Country
Japan
Facility Name
Local Institution
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
3508550
Country
Japan
Facility Name
Local Institution
City
Sayama-shi
State/Province
Saitama
ZIP/Postal Code
3501305
Country
Japan
Facility Name
Local Institution
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
4308558
Country
Japan
Facility Name
Local Institution
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
1048560
Country
Japan
Facility Name
Local Institution
City
Itabashi-ku
State/Province
Tokyo
ZIP/Postal Code
1738610
Country
Japan
Facility Name
Local Institution
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1528902
Country
Japan
Facility Name
Local Institution
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
1538515
Country
Japan
Facility Name
Local Institution
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
1608582
Country
Japan
Facility Name
Local Institution
City
Anyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Local Institution
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Facility Name
Local Institution
City
Mexicali
State/Province
Baja California
Country
Mexico
Facility Name
Local Institution
City
Mexico City
State/Province
Distrito Fededral
ZIP/Postal Code
11850
Country
Mexico
Facility Name
Local Institution
City
León
State/Province
Guanajuato
ZIP/Postal Code
37000
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Local Institution
City
Guadalajara
Country
Mexico
Facility Name
Local Institution
City
México D.F.
Country
Mexico
Facility Name
Local Institution
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Local Institution
City
Monaco
ZIP/Postal Code
98012
Country
Monaco
Facility Name
Local Institution
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Local Institution
City
Lima
ZIP/Postal Code
27
Country
Peru
Facility Name
Acq Medic Sac
City
Lima
ZIP/Postal Code
LIMA 11
Country
Peru
Facility Name
Clinica El Golf
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
City
Lima
ZIP/Postal Code
LIMA 33
Country
Peru
Facility Name
Nszoz Unica Cr
City
Dabrowka
ZIP/Postal Code
62-069
Country
Poland
Facility Name
Nzoz Mak Med
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
SANUS Szpital Specjalistyczny Sp. z o.o.
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Local Institution
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
Slaski Szpital Reumatologiczno - Rehabilitacyjny
City
Ustron
ZIP/Postal Code
43-450
Country
Poland
Facility Name
Instytut Reumatologii, I Klinika Reumatologii
City
Warszawa
ZIP/Postal Code
02637
Country
Poland
Facility Name
Centrum Medyczne AMED Sp. z o.o.
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Local Institution
City
Doha
Country
Qatar
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
011192
Country
Romania
Facility Name
Local Institution
City
Bucuresti
ZIP/Postal Code
020983
Country
Romania
Facility Name
Local Institution
City
Cluj-napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Local Institution
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Facility Name
Local Institution
City
St Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
Facility Name
Local Institution
City
St.petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
Yaroslavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
117549
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
Facility Name
Local Institution
City
Port Elizabeth
State/Province
Eastern CAPE
ZIP/Postal Code
6045
Country
South Africa
Facility Name
Local Institution
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Local Institution
City
Pinelands, Cape Town
State/Province
Western Cape
ZIP/Postal Code
7405
Country
South Africa
Facility Name
Local Institution
City
Stellenbosch
State/Province
Western Cape
ZIP/Postal Code
7600
Country
South Africa
Facility Name
Local Institution
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Santiago Compostela
ZIP/Postal Code
15702
Country
Spain
Facility Name
Local Institution
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Local Institution
City
Malmo
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution
City
Leeds
State/Province
North Yorkshire
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Local Institution
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Local Institution
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
Learn more about this trial
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
We'll reach out to this number within 24 hrs