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

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	1/26/2018
Start Date:	January 2011
End Date:	November 2016

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.

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

We found this trial at

sites

Altoona Center for Clinical Research

Duncansville, Pennsylvania 16635

from

Duncansville, PA