Effects of Abatacept in Patients With Early Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT02504268
- Lead Sponsor
- Bristol-Myers Squibb
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 994
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Abatacept Placebo Abatacept Placebo Placebo for Abatacept subcutaneous injection once per week Methotrexate Placebo Methotrexate Placebo Placebo to match Methotrexate capsule orally once per week Combination Therapy: Abatacept + Methotrexate Abatacept Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Combination Therapy: Abatacept + Methotrexate Methotrexate Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week Methotrexate treatment Methotrexate Methotrexate at least 15mg per week tablet or capsule orally
- Primary Outcome Measures
Name Time Method Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24 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
Name Time Method Percentage of Participants in SDAI Remission at Week 52 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 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 Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24 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 Boolean Remission at Week 52 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.
Trial Locations
- Locations (91)
Arizona Arthritis & Rheumatology Research PLLC
🇺🇸Sun City, Arizona, United States
Rheumatology Associates Of North Alabama, P.C.
🇺🇸Huntsville, Alabama, United States
CHI St. Vincent Medical Group Hot Springs
🇺🇸Hot Springs, Arkansas, United States
St. Joseph Heritage Medical Group
🇺🇸Fullerton, California, United States
Arkansas Primary Care Clinic
🇺🇸Little Rock, Arkansas, United States
Joao Nascimento
🇺🇸Bridgeport, Connecticut, United States
Valerius Medical Group and Research Center
🇺🇸Los Alamitos, California, United States
Inland Rheumatology Clinical Trials Inc.
🇺🇸Upland, California, United States
Healthcare Partners Medical Group
🇺🇸Huntington Beach, California, United States
Rheumatology Associates Of Central Florida, P.A.
🇺🇸Orlando, Florida, United States
Tampa Medical Group, Pa
🇺🇸Tampa, Florida, United States
Coeur D'Alene Arthrit Clin
🇺🇸Coeur d'Alene, Idaho, United States
Arthritis And Diabetes Clinic
🇺🇸Monroe, Louisiana, United States
Physician Research Collaboration, Llc
🇺🇸Lincoln, Nebraska, United States
Arthritis Consultants
🇺🇸Saint Louis, Missouri, United States
Physicians Research Center, Llc
🇺🇸Toms River, New Jersey, United States
Klein And Associates, M.D., Pa
🇺🇸Hagerstown, Maryland, United States
St. Paul Rheumatology, P.A.
🇺🇸Eagan, Minnesota, United States
Albuquerque Center For Rheumatology
🇺🇸Albuquerque, New Mexico, United States
Hospital For Special Surgery
🇺🇸New York, New York, United States
Albuquerque Clinical Trials
🇺🇸Albuquerque, New Mexico, United States
Carolina Arthritis Associates
🇺🇸Wilmington, North Carolina, United States
Local Institution
🇬🇧Manchester, United Kingdom
Oklahoma Ctr For Arthritis Therapy And Research, Inc.
🇺🇸Tulsa, Oklahoma, United States
Altoona Center For Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Pmg Research Of Salisbury
🇺🇸Salisbury, North Carolina, United States
The Arthritis Group
🇺🇸Philadelphia, Pennsylvania, United States
Clinical Research Center Of Reading, Llp
🇺🇸Wyomissing, Pennsylvania, United States
West Tennessee Research Institute
🇺🇸Jackson, Tennessee, United States
Arthritis Clinic Of Northern Virginia, P.C.
🇺🇸Arlington, Virginia, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States
Houston Institute For Clinical Research
🇺🇸Houston, Texas, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Organizacion Medica De Investigacion S.A. (Omi)
🇦🇷Capital Federal, Buenos Aires, Argentina
Arthritis Northwest
🇺🇸Spokane, Washington, United States
Rheumatic Disease Center
🇺🇸Glendale, Wisconsin, United States
Caici
🇦🇷Rosario, Santa FE, Argentina
Hospital Privado-Centro Medico De Cordoba S.A.
🇦🇷Cordoba, Argentina
Centro Consultora Integral de Salud SRL
🇦🇷Cordoba, Argentina
Centro Medico Privado De Reumatologia
🇦🇷Tucuman, Argentina
Centro De Investigaciones Reumatologicas
🇦🇷Tucuman, Argentina
Centro Medico de Reumatologia Limitada
🇨🇱Temuco, Araucania, Chile
Rheuma Zentrum Favoriten
🇦🇹Wien, Austria
Centro de Investigacion en Reumatologia y Especialidades Medicas S.A.S
🇨🇴Bogota, Colombia
Revmatologicky ustav
🇨🇿Praha 2, Czechia
Hospital Pablo Tobon Uribe
🇨🇴Medellin, Colombia
Rheumatologische Schwerpunktpraxis Dr. Zinke
🇩🇪Berlin, Germany
Oddeleni klinicke farmakologie
🇨🇿Plzen-Bory, Czechia
MEDICAL PLUS, s.r.o.
🇨🇿Uherske Hradiste, Czechia
Charite Campus Mitte
🇩🇪Berlin, Germany
Rheumapraxis Dr. Kurthen
🇩🇪Aachen, Germany
Immanuel Krankenhaus Berlin/Rheumaklinik Berlin Buch
🇩🇪Berlin, Germany
Schlosspark-Klinik
🇩🇪Berlin, Germany
Klinikum Der Albrecht-Ludwigs-Universitat
🇩🇪Freiburg, Germany
Schwerpunktpraxis fuer Rheumatologie an den Kreiskliniken
🇩🇪Burghausen, Germany
MVZ Rheuma
🇩🇪Hamburg, Germany
Rheumatologie In Wuermtal
🇩🇪Planegg, Germany
Gemeinschaftspraxis Drs. von Hinueber u Demary
🇩🇪Hildesheim, Germany
Hamburger Rheuma Forschungszentrum
🇩🇪Hamburg, Germany
Praxis Dr. Walter
🇩🇪Rendsburg, Germany
Belgyogy. Int. Reuma. DEOEC
🇭🇺Debrecen, Hungary
Reumatologiai Osztaly Flor F.
🇭🇺Kistarcsa, Hungary
Ospedale Borgo Roma
🇮🇹Verona, Italy
Acq Medic Sac
🇵🇪Lima, Peru
Clinica El Golf
🇵🇪Lima, Peru
SANUS Szpital Specjalistyczny Sp. z o.o.
🇵🇱Stalowa Wola, Poland
Slaski Szpital Reumatologiczno - Rehabilitacyjny
🇵🇱Ustron, Poland
Instytut Reumatologii, I Klinika Reumatologii
🇵🇱Warszawa, Poland
Centrum Medyczne AMED Sp. z o.o.
🇵🇱Warszawa, Poland
PV Medical Services, s.r.o.
🇨🇿Zlin, Czechia
Nzoz Mak Med
🇵🇱Nadarzyn, Poland
Ospedale Vittorio Emanuele
🇮🇹Catania, Italy
Istituto Gaetano Pini
🇮🇹Milano, Italy
Azienda Ospedaliera Luigi Sacco
🇮🇹Milano, Italy
Framingham Centro Medico
🇦🇷La Plata, Buenos Aires, Argentina
Arthritis And Osteoporosis Associates, Pa
🇺🇸Freehold, New Jersey, United States
Hospital General De Agudos J.M. Ramos Mejia
🇦🇷Ciudad Autonoma De Buenos Aire, Buenos Aires, Argentina
Instituto de Asistencia Reumatologica Integral
🇦🇷San Fernando, Buenos Aires, Argentina
Fundacion Instituto de Reumatologia Fernando Chalem
🇨🇴Bogota, Colombia
Reumatologiai Osztaly MAV
🇭🇺Szolnok, Hungary
Instituto De Rehabilitacion Psicofisica
🇦🇷Buenos Aires, Argentina
Centro De Estudios Reumatologicos
🇨🇱Santiago De Chile, Metropolitana, Chile
Someal
🇨🇱Santiago, Metropolitana, Chile
Nszoz Unica Cr
🇵🇱Dabrowka, Poland
Vaszary Kolos Hospital
🇭🇺Esztergom, Hungary
Vital Medical Center
🇭🇺Veszprem, Hungary
Clinica de Artritis Temprana
🇨🇴Cali, Colombia
Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac
🇵🇪Lima, Peru
Pmg Research Of Wilmington Llc
🇺🇸Wilmington, North Carolina, United States
Health Research Of Oklahoma
🇺🇸Oklahoma City, Oklahoma, United States
Centre De Recherche Musculo-Squelettique
🇨🇦Trois-rivieres, Quebec, Canada