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A Randomized, Double- Blind, Controlled, Parallel-group, Multicenter Study to Assess the Safety and Immunogenicity of Transitioning to GP2013 or Re-treatment With Rituxan® or MabThera® in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®
The study objective is to identify potential safety risks of the transition from US-licensed Rituxan® or EU-approved MabThera® to GP2013 (proposed biosimilar product) as compared to continuous treatment with the originator product in terms of general safety and immunogenicity.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
Clinical and Translational Research Center of Alabama PC
Tuscaloosa, Alabama, United States
Arizona Arthritis & Rheumatology Research, PLLC
Glendale, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Mesa, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, United States
TriWest Research Associates, LLC
El Cajon, California, United States
Valerius Medical Group and Research Center of Greater Long Beach, Inc
Long Beach, California, United States
Pacific Arthritis Center Medical Group
Santa Maria, California, United States
Westlake Medical Research Inc.
Thousand Oaks, California, United States
Start Date
July 1, 2015
Primary Completion Date
July 1, 2016
Completion Date
October 1, 2016
Last Updated
December 28, 2017
107
ACTUAL participants
GP2013 - A Proposed biosimilar rituximab
BIOLOGICAL
Originator rituximab - Rituxan ® or MabThera ®
BIOLOGICAL
Lead Sponsor
Sandoz
Collaborators
NCT07484243
NCT06647069
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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