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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274182
First Posted: January 11, 2011
Last Update Posted: December 19, 2016
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.
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz
January 10, 2011
January 11, 2011
December 19, 2016
January 2011
January 2016   (Final data collection date for primary outcome measure)
Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RA [ Time Frame: 24 weeks ]
Same as current
Complete list of historical versions of study NCT01274182 on ClinicalTrials.gov Archive Site
  • Additional pharmacokinetic (PK) parameters, pharmacodynamic (PD) and efficacy of GP2013 and rituximab in subjects with RA [ Time Frame: 1.5 years ]
  • Safety and tolerability of GP2013 and rituximab in patients with RA [ Time Frame: 1.5 years ]
Same as current
Not Provided
Not Provided
 
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.
The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: GP2013
    1000 mg
  • Biological: rituximab
    1000 mg
  • Experimental: GP2013
    Intervention: Biological: GP2013
  • Active Comparator: rituximab
    Intervention: Biological: rituximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
November 2016
January 2016   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Austria,   Belgium,   Brazil,   France,   Germany,   India,   Italy,   Romania,   Spain,   Turkey,   United States
 
 
NCT01274182
GP13-201
2010-021184-32 ( EudraCT Number )
GPN013A2301 ( Other Identifier: Novartis )
Yes
Not Provided
Not Provided
Sandoz
Sandoz
Novartis Pharmaceuticals
Study Director: Sandoz Biopharmaceuticals Sandoz
Sandoz
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP