Rheumatoid Arthritis Extension Trial For Subjects Who Have Participated In Other PF-05280586 Trials (REFLECTIONS B328-04)

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab-Pfizer (PF-05280586) x 3 courses — BIOLOGICAL
  1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
• Rituximab-EU+ Rituximab-Pfizer x 2 Courses — BIOLOGICAL
  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
• Rituximab-US + Rituximab-Pfizer x 2 Courses — BIOLOGICAL
  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

Study Details

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.

Key Dates

Start date

Aug 16, 2012

Status verified

Jan 2019

Primary completion

Mar 14, 2016

Completion

Mar 14, 2016

Study Design

Enrollment

185 participants (actual)

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab-Pfizer
• Active Comparator: Rituximab-EU+Rituximab-Pfizer
  Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses.
• Active Comparator: Rituximab-US+Rituximab-Pfizer
  Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses.

Primary Outcome Measure

Percentage of Participants by Anti-Drug Antibody (ADA) Status Using Anti-PF-05280586 Antibody Assay [ Time Frame: Course 1 (C1) Overall, Course 2 (C2) Overall, Course 3 (C3) Overall, and All Courses Overall. ]

Locations (34)

Find similar trials in Birmingham, AL

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