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GP2013 Treatment in Patients With Active Rheumatoid Arthritis, Previously Treated With Rituxan® or MabThera®

NCT02514772 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 107

Last updated 2017-12-28

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

GP2013 - A Proposed biosimilar rituximab

BIOLOGICAL

Originator rituximab - Rituxan ® or MabThera ®

Sponsors & Collaborators

  • Hexal AG

    collaborator INDUSTRY

  • Sandoz

    lead INDUSTRY

Principal Investigators

  • Sandoz Inc. · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2016-07-31
Completion
2016-10-31

Countries

  • United States
  • Germany
  • Hungary
  • Poland

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 NCT02514772 on ClinicalTrials.gov