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

Completed · Phase 1/Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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

Key facts

Study ID

NCT01274182

Run by

Sandoz

People needed

312

Starts

2011-01-01

Expected to finish

2016-11-01

Last updated by the study team

2018-01-24

Who can join

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

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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• Miller Clinical Research — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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