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GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01274182
Recruitment Status : Completed
First Posted : January 11, 2011
Last Update Posted : December 19, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Biological: GP2013 Biological: rituximab Phase 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Controlled Study to Evaluate PK, PD, Safety and Efficacy of GP2013 and Rituximab in Patients With Rheumatoid Arthritis Refractory or Intolerant to Standard DMARDs and up to Three Anti-TNF Therapies.
Study Start Date : January 2011
Primary Completion Date : January 2016
Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: GP2013 Biological: GP2013
1000 mg
Active Comparator: rituximab Biological: rituximab
1000 mg

Outcome Measures

Primary Outcome Measures :
  1. Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RA [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and efficacy of GP2013 and rituximab in subjects with RA [ Time Frame: 1.5 years ]
  2. Safety and tolerability of GP2013 and rituximab in patients with RA [ Time Frame: 1.5 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Rheumatoid arthritis as defined by the 1987 ACR classification
  • Severe active seropositive disease
  • Inadequate response or intolerance to other DMARDs and anti-TNFs
  • Treatment with Methotrexate

Exclusion Criteria:

  • Patients with systemic manifestations of rheumatoid arthritis
  • 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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274182

  Hide Study Locations
United States, California
Miller Clinical Research
Los Angeles, California, United States, 90057
United States, Kentucky
Bluegrass Community Research, Inc.
Lexington, Kentucky, United States, 40504
United States, Maryland
Klein & Associates
Cumberland, Maryland, United States, 21502
Klein & Associates
Hagerstown, Maryland, United States, 21740
United States, Massachusetts
Clinical Pharmacology Study Group
Worcester, Massachusetts, United States, 01605
United States, Nebraska
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States, 68516
United States, Nevada
Innovative Health Research
Las Vegas, Nevada, United States, 89128
United States, North Carolina
DJL Clinical Research PLLC
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, United States, 19610
United States, South Carolina
Low Country Rheumatology, PA
Charleston, South Carolina, United States, 29406
United States, South Dakota
Regional Health Clinical Research
Rapid City, South Dakota, United States
United States, Tennessee
West Tennessee Research Institute
Jackson, Tennessee, United States, 38305
United States, Texas
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, United States, 78232
United States, Washington
The Seattle Arthritis Center
Seattle, Washington, United States, 98133
Investigative Site
Buenos Aires#1, Argentina
Investigative Site
Buenos Aires#2, Argentina
Investigative Site
Innsbruck, Austria
Investigative Site
Vienna#1, Austria
Investigative site
Kortrijk, Belgium
Investigative site
Merksem, Belgium
Investigative Site
Curitiba, Brazil
Investigative Site
Goiânia, Brazil
Investigative Site
Sao Paulo#1, Brazil
Investigative site
Sao Paulo#2, Brazil
Investigative Site
Amiens Cedex, France
Investigative site
Cahors, France
Investigative Site
Corbeil Essonnes, France
Investigative site
La Gaillarde, France
Investigative Site
Orleans, France
Investigative Site
Frankfurt, Germany
Investigative Site
Freiburg, Germany
Investigative Site
Göttingen, Germany
Investigative Site
Hildesheim, Germany
Investigative Site
Jena, Germany
Investigative Site
München, Germany
Investigative Site
Nürnberg, Germany
Investigative Site
Ratingen, Germany
Investigative Site
Regensburg, Germany
Investigative Site
Würzburg, Germany
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
Milano, Italy
Investigative site
Bucharest#1, Romania
Investigative site
Bucharest#2, Romania
Investigative site
Cluj, Romania
Investigative Site
Madrid, Spain
Investigative site
Majadanonda, Spain
Investigative Site
Mérida, Spain
Investigative site
Santiago de Compostela, Spain
Investigative Site
Sevilla, Spain
Investigative Site
Istanbul, Turkey
Investigative Site
Izmir, Turkey
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Sandoz Biopharmaceuticals Sandoz
More Information

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01274182     History of Changes
Other Study ID Numbers: GP13-201
2010-021184-32 ( EudraCT Number )
GPN013A2301 ( Other Identifier: Novartis )
First Posted: January 11, 2011    Key Record Dates
Last Update Posted: December 19, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents