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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Sandoz
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01274182
First received: January 10, 2011
Last updated: July 3, 2014
Last verified: May 2012

January 10, 2011
July 3, 2014
January 2011
November 2015   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Safety and tolerability of GP2013 and rituximab in patients with RA [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
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: Double Blind (Subject, Caregiver, 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.
 
Recruiting
297
Not Provided
November 2015   (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

Both
18 Years and older
No
Contact: Sandoz Biopharmaceuticals +498024 908 ext 0
Argentina,   Austria,   Belgium,   Brazil,   France,   Germany,   India,   Italy,   Romania,   Spain,   Turkey
 
NCT01274182
GP13-201, 2010-021184-32, GPN013A2301
Yes
Sandoz
Sandoz
Novartis Pharmaceuticals
Study Director: Sandoz Biopharmaceuticals Sandoz
Sandoz
May 2012

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