A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES
A RANDOMIZED, DOUBLE-BLIND, STUDY COMPARING THE PHARMACOKINETICS AND PHARMACODYNAMICS, AND ASSESSING THE SAFETY OF PF-05280586 AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON A BACKGROUND OF METHOTREXATE WHO HAVE HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF ANTAGONIST THERAPIES
In this study, patients with moderate to severe rheumatoid arthritis who are being treated with methotrexate will receive 2 intravenous treatments with either PF-05280586 or Rituxan (Rituximab) or MabThera (Rituximab). During the course of the study, the effects of the drugs will be assessed by sampling the levels of drug in the blood, blood cell counts, and by comparing these levels among the different treatments. Safety, tolerability and immunologic response also will be evaluated throughout.
Inclusion Criteria:
Exclusion Criteria:
Birmingham, Alabama 35294, United States
Tampa, Florida 33612, United States
Worcester, Massachusetts 01605, United States
Great Neck, New York 11021, United States
Hickory, North Carolina 28602, United States
Woodville South, South Australia 5011, Australia
Barranquilla, Colombia, Atlántico, Colombia
Barranquilla, Colombia, Atlántico, Colombia
Barranquilla, Colombia, Atlántico, Colombia
San Luis Potosà City, 78200, Mexico
Kemerovo, 650000, Russia
Saint Petersburg, 190068, Russia
Samara, 443095, Russia
Tomsk, 634063, Russia
Leeds, LS1 3EX, United Kingdom