GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy
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.
3 other identifiers
interventional
312
13 countries
56
Brief Summary
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 rheumatoid-arthritis
Started Jan 2011
Longer than P75 for phase_1 rheumatoid-arthritis
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 10, 2011
CompletedFirst Posted
Study publicly available on registry
January 11, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
January 24, 2018
CompletedJanuary 24, 2018
January 1, 2018
5 years
January 10, 2011
November 9, 2017
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169
From baseline to 24 weeks
Secondary Outcomes (7)
Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
From baseline to week 24
Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA
14 days
Change From Baseline in DAS28(CRP) at Week 24
24 weeks
Number of Patients With ACR20 (CRP) Response
24 weeks
Summary of Disease Activity According to CDAI
At week 24
- +2 more secondary outcomes
Other Outcomes (1)
Number of Patients With at Least One Anti-Drug-Antibody (ADA) Positive Serum Sample
through study completion, an average of 1 year
Study Arms (3)
GP2013
EXPERIMENTALMabThera
ACTIVE COMPARATORRituxan
ACTIVE COMPARATORInterventions
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sandozlead
- Novartis Pharmaceuticalscollaborator
Study Sites (57)
Miller Clinical Research
Los Angeles, California, 90057, United States
Bluegrass Community Research, Inc.
Lexington, Kentucky, 40504, United States
Klein & Associates
Cumberland, Maryland, 21502, United States
Klein & Associates
Hagerstown, Maryland, 21740, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01605, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516, United States
Innovative Health Research
Las Vegas, Nevada, 89128, United States
DJL Clinical Research PLLC
Charlotte, North Carolina, 28210, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, 73103, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Clinical Research Center of Reading LLC
Wyomissing, Pennsylvania, 19610, United States
Low Country Rheumatology, PA
Charleston, South Carolina, 29406, United States
Regional Health Clinical Research
Rapid City, South Dakota, United States
West Tennessee Research Institute
Jackson, Tennessee, 38305, United States
Arthritis & Osteoporosis Center of South Texas
San Antonio, Texas, 78232, United States
The Seattle Arthritis Center
Seattle, Washington, 98133, 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, 2143, Hungary
Megyei Csolnoky Ferenc Kórház Nonprofit Zrt.
Veszprém, H-2800, 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)
Related Publications (1)
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.
PMID: 28637670DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Program Medical Director
- Organization
- Sandoz
Study Officials
- STUDY DIRECTOR
Sandoz Biopharmaceuticals
Sandoz
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2011
First Posted
January 11, 2011
Study Start
January 1, 2011
Primary Completion
January 1, 2016
Study Completion
November 1, 2016
Last Updated
January 24, 2018
Results First Posted
January 24, 2018
Record last verified: 2018-01