At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EXTENSION STUDY EVALUATING TREATMENT WITH PF-05280586 VERSUS RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE PARTICIPATED IN OTHER PF-05280586 CLINICAL TRIALS
In Brief
A clinical study evaluating Rituximab-Pfizer (PF-05280586) x 3 courses, Rituximab-EU+ Rituximab-Pfizer x 2 Courses, and 1 other intervention for Rheumatoid Arthritis. Completed, enrolled 185 participants across 71 sites in 10 countries.
Detailed Summary
This extension study will evaluate the safety (including immunogenicity) of treatment with rituximab-Pfizer, as well as the safety and immunogenicity after transitioning from rituximab-US or rituximab-EU to rituximab-Pfizer. This study will provide continued treatment access to subjects with active rheumatoid arthritis who have participated for at least 16 weeks in other studies in the rituximab Pfizer program.
Study Details
Timeline
Interventions
1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses