GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
NCT ID: NCT01274182
Last Updated: 2018-01-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
312 participants
INTERVENTIONAL
2011-01-31
2016-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GP2013
GP2013
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
MabThera
MabThera
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Rituxan
Rituxan
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Interventions
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GP2013
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
MabThera
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Rituxan
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Severe active seropositive disease
* Inadequate response or intolerance to other DMARDs and anti-TNFs
* Treatment with Methotrexate
Exclusion Criteria
* Female patients nursing
* Women of childbearing potential unless using birth control
* Active infection
* Known immunodeficiency syndrome
* Positive Hepatitis B surface antigen or antibodies to Hepatitis C
* History of cancer
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Sandoz
INDUSTRY
Responsible Party
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Principal Investigators
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Sandoz Biopharmaceuticals
Role: STUDY_DIRECTOR
Sandoz
Locations
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Miller Clinical Research
Los Angeles, California, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States
Klein & Associates
Cumberland, Maryland, United States
Klein & Associates
Hagerstown, Maryland, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Innovative Health Research
Las Vegas, Nevada, United States
DJL Clinical Research PLLC
Charlotte, North Carolina, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Regional Health Clinical Research
Rapid City, South Dakota, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, United States
The Seattle Arthritis Center
Seattle, Washington, United States
Investigative Site
Buenos Aires, , Argentina
Investigative Site
Innsbruck, , Austria
Investigative Site
Vienna, , Austria
Investigative site
Kortrijk, , Belgium
Investigative site
Merksem, , Belgium
Investigative Site
Curitiba, , Brazil
Investigative Site
Goiânia, , Brazil
Investigative Site
São Paulo, , Brazil
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Investigative Site
Amiens, , France
Investigative site
Cahors, , France
Investigative Site
Corbeil-Essonnes, , France
Investigative site
La Gaillarde, , France
Investigative Site
Orléans, , France
Investigative Site
Frankfurt, , Germany
Investigative Site
Freiburg im Breisgau, , Germany
Investigative Site
Göttingen, , Germany
Investigative Site
Hildesheim, , Germany
Investigative Site
Jena, , Germany
Investigative Site
München, , Germany
Investigative Site
Nuremberg, , Germany
Investigative Site
Ratingen, , Germany
Investigative Site
Regensburg, , Germany
Investigative Site
Würzburg, , Germany
Pest Megyei Flór Ferenc
Kistarcsa, , Hungary
Megyei Csolnoky Ferenc Kórház Nonprofit Zrt.
Veszprém, , Hungary
Investigative site
Ajmer, , India
Investigative Site
Bangalore, , India
Investigative Site
Hyderabad, , India
Investigative Site
Jaipur, , India
Investigative Site
New Delhi, , India
Investigative Site
Secunderabad, , India
Investigative Site
Milan, , Italy
Investigative site
Bucharest, , Romania
Investigative site
Cluj-Napoca, , Romania
Investigative Site
Madrid, , Spain
Investigative Site
Mérida, , Spain
Investigative site
Santiago de Compostela, , Spain
Investigative Site
Seville, , Spain
Investigative Site
Istanbul, , Turkey (Türkiye)
Investigative Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Smolen JS, Cohen SB, Tony HP, Scheinberg M, Kivitz A, Balanescu A, Gomez-Reino J, Cen L, Zhu P, Shisha T. A randomised, double-blind trial to demonstrate bioequivalence of GP2013 and reference rituximab combined with methotrexate in patients with active rheumatoid arthritis. Ann Rheum Dis. 2017 Sep;76(9):1598-1602. doi: 10.1136/annrheumdis-2017-211281. Epub 2017 Jun 21.
Other Identifiers
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2010-021184-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GPN013A2301
Identifier Type: OTHER
Identifier Source: secondary_id
GP13-201
Identifier Type: -
Identifier Source: org_study_id
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