TL011 in Severe, Active Rheumatoid Arthritis Patients

A Phase Ib Study Evaluating Safety, Pharmacokinetic and Pharmacodynamic Profiles of a Single Course of TL011 Infusions in Subjects With Severe, Active Rheumatoid Arthritis

The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.

Inclusion Criteria:

• Adult subjects
• Rheumatoid arthritis as defined by the 1987 ACR Classification
• Severe active seropositive disease
• Inadequate response or intolerance to other DMARDs
• Treatment with MTX

Exclusion Criteria:

• Rheumatic autoimmune disease other than RA
• Active infection
• Known immunodeficiency syndrome
• Positive Hepatitis B surface antigen or antibodies to Hepatitis C
• History of cancer