Clinical trial NCT00559585: Methotrexate-Inadequate Response Study
Official title: A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 2492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subjects who are considered methotrexate inadequate responders
* 10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Exclusion Criteria:

* Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
* Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
* Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
* Subjects with severe chronic or recurrent bacterial infections
* Subjects who have received treatment with rituximab

An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.

Primary outcomes:
measure: Double-blind Period: Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Day 169
timeFrame: Day 169
measure: Anti-TNF Failure Sub-Study Double Blind Period : Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Response in Anti-TNF Failure Population
timeFrame: Days 85, and 169 and postvisits on Days 28, 56, and 85
Secondary outcomes:
measure: Double-blind Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Day 169
timeFrame: Day 169
measure: Double-blind Period: Mean Baseline Health Assessment Questionnaire Disability Index (HAQ-DI) for Participants With Assessments at Day 169
timeFrame: Day 169
measure: Double-blind Period: Adjusted Mean Change From Baseline to Day 169 in HAQ-DI
timeFrame: Baseline to Day 169
measure: Double-blind Period: Number of Participants Achieving Clinically Meaningful HAQ-DI Response at Day 169
timeFrame: Day 169
measure: Double-blind Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation
timeFrame: Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.
measure: Anti-TNF Failure Sub-study Double-blind Period: Number of Participants With SAEs, AEs Leading to Discontinuation or Who Died
timeFrame: Day 1 to 56 days after last dose in short-term or first dose in the long-term, whichever occurs first.
measure: Double-blind Period: Number of Participants With AEs of Special Interest
timeFrame: Day 1 up to 56 days post last dose in short- term period or first dose in the long -term period, whichever occurs first.
measure: Double-blind Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements
timeFrame: Day 1 through end of short-term period (Day 169)
measure: Double-blind Period: Number of Participants With Hematology Laboratory Test Results Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 through end of short-term period (Day 169)
measure: Double-blind Period: Number of Participants With Liver Function Laboratory Test Results Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 through end of short-term period (Day 169)
measure: Double-blind Period: Number of Participants With Electrolyte Laboratory Test Results Meeting the Criteria for Marked Abnormality
timeFrame: Day 1 through end of short-term period (Day 169)
measure: Double-blind Period: Minimum Observed Serum Concentration of Abatacept
timeFrame: Days 57, 85, 113, 120, 127, 134, 141, and 169
measure: Anti-TNF Failure Sub-study Double-blind Period: Minimum Observed Serum Concentration (Cmin) of Abatacept
timeFrame: Days 57, 85, 113, 120, 127, 134, 141, and 169 (ST Period)
measure: Double-blind Period: Maximum Observed Serum Concentration of Abatacept
timeFrame: End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous
measure: Anti-TNF Failure Substudy Double Blind Period: Geometric Mean Maximum Observed Serum Concentration of Abatacept
timeFrame: End of infusion on Days 1 and 113 for IV infusion and in the dosing interval of Days 113 to 120 for subcutaneous
measure: Double-blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept
timeFrame: Dosing interval between Days 113 and 141 (TAU=28 days)
measure: Anti-TNF Failure Sub-study Double Blind Period: Area Under The Curve In A Dose Interval (AUC TAU) of Abatacept
timeFrame: Dosing Interval between Days 113 and 141 (TAU=28 days)
measure: Double-blind Period: Number of Participants With Positive Anti-abatacept or Anti-Cytotoxic T Lymphocyte Antigen 4-T Cell (CTLA4-T) Responses Over Time by Enzyme Linked Immunoabsorbant Assay (ELISA)
timeFrame: Days 85, and 169 and postvisits on Days 28, 56, and 85
measure: Double-blind Period: Time-matched Median Percent Change From Baseline in Levels of Serum C-reactive Protein Over the Short-term Period
timeFrame: Baseline to Days 15, 29, 57, 85, 113, 141, and 169
measure: Double-blind Period: Number of Participants With Positive Anti-abatacept Responses Over Time by Electrochemiluminescence Immunoassay Among the First 10% of Participants Randomized
timeFrame: Days 85, and 169 and postvisits on Days 28, 56, and 85
measure: Double-blind Period: Number of Participants Seroconverting by Day 169 According to Status (Negative or Positive) at Baseline
timeFrame: Baseline to Day 169
measure: Open-Label LT Period: Number of Participants Achieving ACR 20 Response at Days 169, 729, 1261, and 1821
timeFrame: Days 169, 729, 1261, 1821
measure: Open-Label LT Period: Number of Participants Achieving ACR 50 and ACR 70 Responses at Days 169, 729, 1261, 1821
timeFrame: Days 169, 729, 1261, 1821
measure: Open-Label LT Period: Mean Change From Baseline in Disease Activity Score in 28 Joints (DAS28) Using C-reactive Protein (CRP) at Days 169, 729, 1261, 1821
timeFrame: Days 169, 729, 1261, 1821
measure: Open-Label LT Period: Number of Participants Achieving DAS 28 Remission at Days 169, 729, 1261, 1821
timeFrame: Days 169, 729, 1261, 1821
measure: Open-Label LT Period: Number of Participants Achieving DAS 28 Low Disease Activity (LDA) at Days 169, 729, 1261, 1821
timeFrame: Days 169, 729, 1261, 1821
measure: Open-Label LT Period: Number of Participants With HAQ-DI Response at Days 169, 729, 1261, 1821
timeFrame: Days 169, 729, 1261, 1821
measure: Open-Label LT Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Treatment-related AEs, or AEs Leading to Discontinuation
timeFrame: End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)
measure: Open-Label LT Period: Number of Participants With AEs of Special Interest
timeFrame: End of ST Period (Day 169) to last dose plus 85 days, up to 5 years (September 2014)
measure: Open-Label LT Period: Number of Participants With Clinically Significant Abnormalities in Vital Sign Measurements
timeFrame: End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)
measure: Open-Label LT Period: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: End of ST Period (Day 169) to last dose plus 7 days, up to 5 years (September 2014)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Rheumatology Associates, Pc
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc
state: Alabama
city: Scottsdale
country: United States
facility: Advanced Arthritis Care & Research
state: Arizona
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research, Inc.
state: Arizona
city: Hot Springs
country: United States
facility: St. Joseph'S Mercy Clinic
state: Arkansas
city: Huntington Beach
country: United States
facility: Talbert Medical Group
state: California
city: La Jolla
country: United States
facility: Allergy & Rheumatology Medical Clinic, Inc.
state: California
city: Long Beach
country: United States
facility: Valerius Medical Group &Research Ctr. Of Greater Long Beach
state: California
city: Palo Alto
country: United States
facility: Stanford University School Of Medicine
state: California
city: San Diego
country: United States
facility: San Diego Arthritis Medical Clinic
state: California
city: Boulder
country: United States
facility: Boulder Medical Center
state: Colorado
city: Colorado Springs
country: United States
facility: Arthritis Assoc And Osteo Ctr Of Col Sprgs
state: Colorado
city: Denver
country: United States
facility: Denver Arthritis Clinic
state: Colorado
city: Loveland
country: United States
facility: Arthritis Center Of The Rockies, Pc
state: Colorado
city: Bridgeport
country: United States
facility: Guadagnoli, Germano
state: Connecticut
city: Bridgeport
country: United States
facility: Joao Nascimento
state: Connecticut
city: Danbury
country: United States
facility: Clinical Research Center Of Ct/Ny
state: Connecticut
city: Aventura
country: United States
facility: Arthritis And Rheumatic Disease Specialties
state: Florida
city: Orange Park
country: United States
facility: Arthritis & Osteoporosis Treatment Center, Pa
state: Florida
city: Orlando
country: United States
facility: Rheumatology Associates Of Central Florida
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: Atlanta
country: United States
facility: Arthritis & Rheumatology Of Georgia,Pc
state: Georgia
city: Boise
country: United States
facility: Boise Rheumatology/ Intermountain Research Center, Inc
state: Idaho
city: Coeur D Alene
country: United States
facility: Coeur D'Alene Arthrit Clin
state: Idaho
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Rockford
country: United States
facility: Rockford Orthopedic Associates, Ltd.
state: Illinois
city: Springfield
country: United States
facility: The Arthritis Center
state: Illinois
city: Cumberland
country: United States
facility: Klein And Associates, M.D., Pa
state: Maryland
city: Worcester
country: United States
facility: Clinical Pharmacology Study Group
state: Massachusetts
city: St. Clair Shores
country: United States
facility: Shores Rheumatology, P. C.
state: Michigan
city: Jackson
country: United States
facility: Arthritis Assoicates Of Mississippi
state: Mississippi
city: Lee'S Summit
country: United States
facility: Kansas City Internal Medicine
state: Missouri
city: Lincoln
country: United States
facility: Physician Research Collaboration, Llc
state: Nebraska
city: Dover
country: United States
facility: Allergy And Arthritis Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: Albuquerque Rehabilitation & Rheumatology Pc
state: New Mexico
city: Albany
country: United States
facility: The Center For Rheumatology, Llp
state: New York
city: Olean
country: United States
facility: Southern Tier Arthritis & Rheumatism
state: New York
city: Syracuse
country: United States
facility: Arthritis Health Associates
state: New York
city: Asheville
country: United States
facility: Asheville Rheumatology & Osteoporosis Research Asso P. A.
state: North Carolina
city: Charlotte
country: United States
facility: The Arthritis Clinic & Carolina Bone & Joint
state: North Carolina
city: Durham
country: United States
facility: Rheumatology
state: North Carolina
city: Greenville
country: United States
facility: Physicians East, Pa
state: North Carolina
city: Statesville
country: United States
facility: Carolina Pharmaceutical Research
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Rheumatic Disease Study Group
state: Ohio
city: Oklahoma City
country: United States
facility: Health Research Of Oklahoma
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Center For Arthritis Therapy And Research
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Eugene
country: United States
facility: Pro Research
state: Oregon
city: Lake Oswego
country: United States
facility: Portland Rheumatology Clinic, Llc
state: Oregon
city: Bethlehem
country: United States
facility: East Penn Rheumatology Associates
state: Pennsylvania
city: Providence
country: United States
facility: Rheumatology Associates
state: Rhode Island
city: Charleston
country: United States
facility: Low Country Rheumatology, Pa
state: South Carolina
city: Columbia
country: United States
facility: Columbia Arthritis Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Carolina Health Specialists
state: South Carolina
city: Orangeburg
country: United States
facility: Acme Research, Llc
state: South Carolina
city: Jackson
country: United States
facility: Arthritis Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Rheumatology Consultants Pllc
state: Tennessee
city: Memphis
country: United States
facility: The Arthritis Group, Pc
state: Tennessee
city: Nashville
country: United States
facility: St. Thomas Hospital Tower East
state: Tennessee
city: Austin
country: United States
facility: Walter F. Chase
state: Texas
city: Houston
country: United States
facility: Rheumatic Disease Clinical Research Center, Llc
state: Texas
city: Houston
country: United States
facility: Accurate Clinical Research
state: Texas
city: Sugarland
country: United States
facility: Texas Research Center
state: Texas
city: Arlington
country: United States
facility: Arthritis Clinic Of Northern Virginia, P.C.
state: Virginia
city: Chesapeake
country: United States
facility: Center For Arthritis & Rheumatic Diseases, Pc
state: Virginia
city: Olympia
country: United States
facility: South Puget Sound Clinincal Research Center
state: Washington
city: Tacoma
country: United States
facility: Tacoma Center For Arthritis Research Ps
state: Washington
city: Ciudad Autonoma
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario, Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Santa Fe
country: Argentina
facility: Local Institution
city: Tucuman
country: Argentina
facility: Local Institution
city: St Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Cairns
country: Australia
facility: Local Institution
state: Queensland
city: Maroochydore
country: Australia
facility: Local Institution
state: Queensland
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Shenton Park
country: Australia
facility: Local Institution
state: Western Australia
city: Bruxelles
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Hasselt
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Wilrijk
country: Belgium
facility: Local Institution
city: Yvoir
country: Belgium
facility: Local Institution
city: Goiania
country: Brazil
facility: Local Institution
state: Goias
city: Goiania
country: Brazil
facility: Local Institution
state: Goias
city: Juiz De Fora
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Recife
country: Brazil
facility: Local Institution
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: St. John'S
country: Canada
facility: Local Institution
state: Newfoundland and Labrador
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Mississauga
country: Canada
facility: Local Institution
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Ste-Foy
country: Canada
facility: Local Institution
state: Quebec
city: Ste-Foy
country: Canada
facility: Local Institution
state: Quebec
city: Trois-Rivieres
country: Canada
facility: Local Institution
state: Quebec
city: Saskatoon
country: Canada
facility: Local Institution
state: Saskatchewan
city: Santiago De Chile
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago De Chile
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Bordeaux Cedex
country: France
facility: Local Institution
city: Brest Cedex
country: France
facility: Local Institution
city: Chambray Les Tours
country: France
facility: Local Institution
city: Le Mans
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Nice Cedex 3
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Poitiers
country: France
facility: Local Institution
city: Strasbourg Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Leipzig
country: Germany
facility: Local Institution
city: Muenchen
country: Germany
facility: Local Institution
city: Munchen
country: Germany
facility: Local Institution
city: Heraklion Crete
country: Greece
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Secunderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Navrangpura, Ahmedabad
country: India
facility: Local Institution
state: Gujarat
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Bangalore
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Lucknow
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Dublin
country: Ireland
facility: Local Institution
city: Napoli
country: Italy
facility: Local Institution
city: Padova
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Siena
country: Italy
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
state: Sungdong-Gu
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daejeon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Tijuana
country: Mexico
facility: Local Institution
state: Baja California
city: Mexico City
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Morelia
country: Mexico
facility: Local Institution
state: Michioacan
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Aguascalientes
country: Mexico
facility: Local Institution
city: Chihuahua
country: Mexico
facility: Local Institution
city: Nuevo Leon
country: Mexico
facility: Local Institution
city: Queretaro
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Leeuwarden
country: Netherlands
facility: Local Institution
city: Callao
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Konskie
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Torun
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Ekaterinburg
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Yaroslavl
country: Russian Federation
facility: Local Institution
city: Kempton Park
country: South Africa
facility: Local Institution
state: Gauteng
city: Muckleneuk
country: South Africa
facility: Local Institution
state: Gauteng
city: Muckleneuk
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Panorama
country: South Africa
facility: Local Institution
state: Western Cape
city: Kaohsiung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Denizli
country: Turkey
facility: Local Institution
city: Edirne
country: Turkey
facility: Local Institution
city: Gaziantep
country: Turkey
facility: Local Institution
city: Cambridge
country: United Kingdom
facility: Local Institution
state: Cambridgeshire
city: Bridgend
country: United Kingdom
facility: Local Institution
state: Glamorgan
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Southampton
country: United Kingdom
facility: Local Institution
state: Hampshire
city: Newcastle Upon Tyne
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Alten R, Bingham CO 3rd, Cohen SB, Curtis JR, Kelly S, Wong D, Genovese MC. Antibody response to pneumococcal and influenza vaccination in patients with rheumatoid arthritis receiving abatacept. BMC Musculoskelet Disord. 2016 May 26;17:231. doi: 10.1186/s12891-016-1082-z.
citation: Genovese MC, Tena CP, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Box J, Legerton CW 3rd, Nasonov E, Durez P, Delaet I, Teng J, Alten R. Subcutaneous abatacept for the treatment of rheumatoid arthritis: longterm data from the ACQUIRE trial. J Rheumatol. 2014 Apr;41(4):629-39. doi: 10.3899/jrheum.130112. Epub 2014 Mar 1.
citation: Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.