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

Sandoz

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Biological: MabThera; Biological: GP2013; Biological: Rituxan

Study type: Interventional

Funder types: Industry

Identifiers

NCT01274182

GP13-201

GPN013A2301 (Other Identifier)

2010-021184-32 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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312 participants in 3 patient groups

GP2013

Experimental group

Treatment:

Biological: GP2013

MabThera

Active Comparator group

Treatment:

Biological: MabThera

Rituxan

Active Comparator group

Treatment:

Biological: Rituxan