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

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02514772

Run by

Sandoz

People needed

107

Starts

2015-07-01

Expected to finish

2016-10-01

Last updated by the study team

2017-12-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of rheumatoid arthritis (RA) according to ACR 2010 criteria
• Completed one full treatment course with either Rituxan® or MabThera®
• Eligible for a further treatment course with Rituxan® or MabThera®- Currently treated with methotrexate

You may not qualify if…

• RA functional status class IV (ACR 1991 revised criteria)
• Systemic manifestation of RA
• Positive serology for hepatitis B or hepatitis C infection
• Active systemic infection
• History of cancer
• Known severely immunocompromised state
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Inland Rheumatology and Osteoporosis Medical Group — Upland, California, United States
• Arthritis Associates & Osteoporosis Center of Colorado Springs — Colorado Springs, Colorado, United States
• Denver Arthritis Clinic — Denver, Colorado, United States
• Bay Area Arthritis and Osteoporosis — Brandon, Florida, United States
• Sunrise Research Institute, Inc. — Miami, Florida, United States
• Omega Research Consultants, LLC — Orlando, Florida, United States
• Arthritis Center — Palm Harbor, Florida, United States
• Arthritis Research of Florida, Inc. — Palm Harbor, Florida, United States
• Southwest Florida Clinical Research Center — Tampa, Florida, United States
• Florida Medical Clinic, PA — Zephyrhills, Florida, United States
• Idaho Arthritis and Osteoporosis Clinic — Meridian, Idaho, United States
• Bluegrass Community Research, Inc. — Lexington, Kentucky, United States
• Arthritis and Rheumatology Consultants, P.A. — Edina, Minnesota, United States
• North Mississippi Medical Clinical, Inc — Tupelo, Mississippi, United States
• Physician Research Collaboration, LLC — Lincoln, Nebraska, United States
• Rheumatology Associates of North Alabama, PC — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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