None listed
Conditions
Interventions
Abatacept (125 mg) in 1ml pre-filled syringes or matching placebo will be administered subcutaneously (SC) once per week, until end of study.
Methotrexate oral (2.5 mg) will initially be dosed at 7
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: a) Subjects have early RA, defined as diagnosis made by the ACR/EULAR 2010 criteria for the classification of RA within the past 6 months b) Subjects must meet at least one of the following criteria: i) CRP > 0.3mg/dL (ULN) ii) ESR > 28mm/hr c) Subjects have at least 3 tender joints and at least 3 swollen joints using the 28 Joint Count Assessment at both screening and Day 1 d) Subjects are positive for anti-citrullinated protein antibodies (ACPA)
Exclusion criteria
Exclusion criteria: a) Subjects at risk for tuberculosis b) Subjects with recent acute infection c) Subjects with history of chronic or recurrent bacterial, viral or systemic fungal infections. d) Subjects who have present or previous malignancies, except documented history of cured non-metastatic squamous or basal skin cell carcinoma, or cervical carcinoma in situ
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea South, Mexico, Netherlands, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, United Arab Emirates, United Kindgdom, United States
Contacts
Public ContactEva Paredes
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed