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

NCT01643928 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 185

Last updated 2019-01-29

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Rituximab-Pfizer (PF-05280586) x 3 courses

1000 mg intravenous infusion \[IV\] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses

BIOLOGICAL

Rituximab-EU+ Rituximab-Pfizer x 2 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

BIOLOGICAL

Rituximab-US + Rituximab-Pfizer x 2 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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-16
Primary Completion
2016-03-14
Completion
2016-03-14

Countries

  • United States
  • Australia
  • Canada
  • Colombia
  • Germany
  • Israel
  • Mexico
  • Russia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01643928 on ClinicalTrials.gov