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
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Biological: GP2013
Biological: rituximab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Sandoz:

Primary Outcome Measures:
  • Compare pharmacokinetics (PK) of GP2013 and rituximab following IV infusion in patients with RA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 297
Study Start Date: January 2011
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GP2013 Biological: GP2013
1000 mg
Active Comparator: rituximab Biological: rituximab
1000 mg

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274182

Contacts
Contact: Sandoz Biopharmaceuticals +498024 908 ext 0

  Hide Study Locations
Locations
Argentina
Investigative Site Recruiting
Buenos Aires#1, Argentina
Investigative Site Recruiting
Buenos Aires#2, Argentina
Austria
Investigative Site Recruiting
Innsbruck, Austria
Investigative Site Recruiting
Vienna#1, Austria
Belgium
Investigative site Completed
Kortrijk, Belgium
Investigative site Completed
Merksem, Belgium
Brazil
Investigative Site Recruiting
Curitiba, Brazil
Investigative Site Recruiting
Goiânia, Brazil
Investigative Site Not yet recruiting
Goiânia, Brazil
Investigative Site Recruiting
Sao Paulo#1, Brazil
Investigative site Recruiting
Sao Paulo#2, Brazil
France
Investigative Site Completed
Amiens Cedex, France
Investigative site Completed
Cahors, France
Investigative Site Completed
Corbeil Essonnes, France
Investigative site Completed
La Gaillarde, France
Investigative Site Completed
Orleans, France
Germany
Investigative Site Recruiting
Frankfurt, Germany
Investigative Site Recruiting
Freiburg, Germany
Investigative Site Recruiting
Göttingen, Germany
Investigative Site Recruiting
Hildesheim, Germany
Investigative Site Recruiting
Jena, Germany
Investigative Site Recruiting
München, Germany
Investigative Site Recruiting
Nürnberg, Germany
Investigative Site Recruiting
Ratingen, Germany
Investigative Site Recruiting
Regensburg, Germany
Investigative Site Recruiting
Würzburg, Germany
India
Investigative site Recruiting
Ajmer, India
Investigative Site Recruiting
Bangalore, India
Investigative Site Recruiting
Hyderabad, India
Investigative Site Recruiting
Jaipur, India
Investigative Site Recruiting
New Delhi, India
Investigative Site Recruiting
Secunderabad, India
Italy
Investigative Site Recruiting
Milano, Italy
Romania
Investigative site Recruiting
Bucharest#1, Romania
Investigative site Recruiting
Bucharest#2, Romania
Investigative site Recruiting
Cluj, Romania
Spain
Investigative Site Recruiting
Madrid, Spain
Investigative site Recruiting
Majadanonda, Spain
Investigative Site Recruiting
Mérida, Spain
Investigative site Recruiting
Santiago de Compostela, Spain
Investigative Site Recruiting
Sevilla, Spain
Turkey
Investigative Site Recruiting
Istanbul, Turkey
Investigative Site Recruiting
Izmir, Turkey
Sponsors and Collaborators
Sandoz
Novartis Pharmaceuticals
Investigators
Study Director: Sandoz Biopharmaceuticals Sandoz
  More Information

No publications provided

Responsible Party: Sandoz
ClinicalTrials.gov Identifier: NCT01274182     History of Changes
Other Study ID Numbers: GP13-201, 2010-021184-32, GPN013A2301
Study First Received: January 10, 2011
Last Updated: July 3, 2014
Health Authority: Argentina: Ministry of Health
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Paul-Ehrlich-Institut
India: Drugs Controller General of India
Italy: Ministry of Health
Romania: National Medicines Agency and Medical Devices
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014