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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/26/2018
Start Date:January 2011
End Date:November 2016

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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


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
We found this trial at
17
sites
Innovative Health Research
Las Vegas, Nevada 89128
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Las Vegas, NV
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Clinical Trial Facility in Buenos Aires#1
Buenos Aires#1,
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mi
from
Buenos Aires#1,
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Low Country Rheumatology
Charleston, South Carolina 29406
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mi
from
Charleston, SC
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DJL Clinical Research
Charlotte, North Carolina 28210
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mi
from
Charlotte, NC
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Klein & Associates, MD, PA
Cumberland, Maryland 21502
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mi
from
Cumberland, MD
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Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
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mi
from
Duncansville, PA
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Klein & Associates MD, PA.
Hagerstown, Maryland 21740
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mi
from
Hagerstown, MD
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West Tennessee Research Institute
Jackson, Tennessee 38305
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mi
from
Jackson, TN
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Bluegrass Community Research, Inc
Lexington, Kentucky 40504
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mi
from
Lexington, KY
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Physician Research Collaboration
Lincoln, Nebraska 68512
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mi
from
Lincoln, NE
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Miller Clinical Research
Los Angeles, California 90057
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mi
from
Los Angeles, CA
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
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mi
from
Oklahoma City, OK
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Regional Health Clinical Research
Rapid City, South Dakota
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mi
from
Rapid City, SD
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Arthritis and Osteoporosis Center of South Texas
San Antonio, Texas 78232
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mi
from
San Antonio, TX
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The Seattle Arthritis Center
Seattle, Washington 98133
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mi
from
Seattle, WA
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Clinical Pharmacology Study Group
Worcester, Massachusetts 01610
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mi
from
Worcester, MA
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Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania 19610
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mi
from
Wyomissing, PA
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