None listed
Conditions
Interventions
All subjects will receive a uniform dose regimen for both adalimumab-EU and adalimumab-Pfizer, which is a subcutaneous (SC) injection at a dose of 40 mg every other week, throughout the study treatmen
20% improvement in both the tender joint count (TJC) (68 joints assessed) and the swollen joint count (SJC) (66 joints assessed) at the end of Treatment Period 1 (Week 26), will discontinue their stud
Sponsors
Pfizer Inc.,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Evidence of a personally signed and dated informed consent document.2.Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, lifestyle guidelines, and other study procedures.3.Male and female subjects aged 18 years or older at the time of informed consent.4.Male and female subjects of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study .5.Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for RA for at least a 4 month duration.6.Meets Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.7.Subjects must have received oral, subcutaneous (SC), or intramuscular (IM) methotrexate for at least 12 weeks and been on a stable dosefor at least 4 weeks prior to first dose of study drug.FOR MORE DETAILS PLEASE SEE THE PROTOCOL
Exclusion criteria
Exclusion criteria: 1.Pregnant females and breastfeeding females, male subjects with partners currently pregnant, or male and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 6 months after the last dose of study drug.2.Clinically significant laboratory abnormalities at Screening, including but not limited to inadequate bone marrow, liver, renal and immune system function.3.Evidence or history of seizures, or nervous system demyelinating diseases (including multiple sclerosis, optic neuritis, Guillain-Barre syndrome).4.Known or Screen test positive for human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus.5.Evidence of untreated or inadequately treated latent, or inadequately treated active infection with tuberculosis (TB).6.Chest radiography with evidence of active TB, fungal infections, or other clinically significant abnormalities taken at Screening or within 12 weeks prior to Screening..FOR MORE DETAILS PLEASE SEE THE PROTOCOL
Countries
Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Croatia, Czech Republic, Estonia, France, Georgia, Germany, Hungary, Japan, Korea South, Lithuania, Mexico, New Zealand, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Taiwan, Ukraine, United Kindgdom, United States
Outcome results
None listed