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.

Sandoz20 sites in 5 countries312 target enrollmentJanuary 2011

ConditionsRheumatoid Arthritis

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Sandoz
Enrollment: 312
Locations: 20
Primary Endpoint: AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

November 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sandoz

Responsible Party

Sponsor

Eligibility 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

Outcomes

Primary Outcomes

AUC(0-inf) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA

Time Frame: From baseline to 24 weeks

Area under the curve AUC(0-inf) calculated based on serum samples, collected from baseline up to 24 weeks: Day 1, 4, 8, 15, 18, 29, 57, 85,113 and 169

Secondary Outcomes

Maximum Serum Concentration (Cmax) of GP2013, MabThera and Rituxan Following IV Infusion in Patients With RA(From baseline to week 24)
Area Under the Effect Curve From Baseline to Day 14 (AUEC(0-14d)) of Percent B-cells of GP2013, MabThera and Rituxan in Patients With RA(14 days)
Change From Baseline in DAS28(CRP) at Week 24(24 weeks)
Number of Patients With ACR20 (CRP) Response(24 weeks)
Summary of Disease Activity According to CDAI(At week 24)
Participant Response as Assessed by EULAR Response Criteria(At week 24)
Summary of Disease Activity According to SDAI(At week 24)