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

This study is currently recruiting participants.
Verified November 2011 by Sandoz
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Sandoz
ClinicalTrials.gov Identifier:
NCT01274182
First received: January 10, 2011
Last updated: November 11, 2011
Last verified: November 2011
History of Changes
  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 One or Two Anti-TNF Therapies.

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

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: 164
Study Start Date: January 2011
Estimated Primary Completion Date: April 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01274182

Contacts
Contact: Sandoz Biopharmaceuticals +498024 908 ext 0

  Show 43 Study Locations
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: November 11, 2011
Health Authority: Argentina: Ministry of Health
Austria: Agency for Health and Food Safety
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
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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013