None listed
Conditions
Interventions
subjects will start their infliximab treatment with a uniform dose regimen, which is an intravenous infusion at a dose of 3 mg/kg , followed by a maintenance regimen of every 8 weeks. The dose will re
or as low as 7.5 mg/week for intolerant subjects) throughout the study. PF-06438179 (infliximab-Pfizer) and infliximab-EU will be supplied by the Sponsor as sterile lyophilized powder containing 100 m
Sponsors
Pfizer Inc.,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. signed and dated informed consent document .2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, 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 must agree to use a highly effective method of contraception throughout the study and for at least 6 months after the last dose of assigned treatment.5. Diagnosis of rheumatoid arthritis (RA) based on 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria (see Appendix 1) 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. Moderately to severely active RA disease as defined by the following criteria: ( see the protocol).8. Stable dose of oral or parenteral methotrexate of 10 to 25 mg/week. Subjects who cannot tolerate 10 to 25 mg/week methotrexate may take a lower dose of as low as7.5 mg/week (as low as 6 mg/week in geographic regions where specified by local guidance). Subjects must have received methotrexate for at least 12 weeks and be on a stable dose for at least 4 weeks prior to first dose of study drug. 9. Stable dose of oral folic (at least 1 mg/day on ≥5 days/week) or folinic acid (≥5 mg once per week) supplementation for at least 21 days prior to the first dose of study drug. FOR MORE DETAILS SEE THE PROTOCOL
Exclusion criteria
Exclusion criteria: 1.Pregnant females and breastfeeding females; males and females of childbearing potential who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after last dose of investigational product.2. Clinically significant laboratory abnormalities at Screening,: a. Hemoglobin (Hgb) <9 g/dL.b. Absolute neutrophil count (ANC) ≤ 1500 cells/mm3.c. White blood cell count <3.0 x 109/L. d. Platelets <100 x 109/L. e. Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 2 times theupper limit of normal. f. Bilirubin ≥ 1.5 times the upper limit of normal. g. Serum creatinine ≥ 1.5 mg/dL. Subjects who do not meet a lab entry criteria but satisfy all other study entry criteria may have the lab re-tested within 14 days and, if within the required range, will be eligible to enroll into the study provided all other inclusion/exclusion criteria are met. 3. Evidence or history of moderate or severe heart failure .4. Evidence of current or recent history of uncontrolled, clinically significant infectious,hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease. 5. Evidence or history of seizures, or nervous system demyelinating diseases 6.Evidence or history of a malignancy within the past 5 years with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin, or cervical carcinoma in situ with no evidence of recurrence. FOR MORE DETAILS SEE THE PROTOCOL
Countries
Arabia Saudi, Argentina, Australia, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Colombia, Czech Republic, France, Georgia, Germany, Guatemala, Hungary, Israel, Japan, Jordan, Korea South, Lithuania, Mexico, Morocco, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, South Africa, Tunisia, Ukraine, United Kindgdom, United States
Outcome results
None listed