A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial, With a Single Ascending-Dose Stage Followed by a Multiple Ascending-Dose Stage, of the Safety, Pharmacokinetics, and Pharmacodynamics of Intravenous and Subcutaneous MTRX1011A in Patients With Rheumatoid Arthritis

This is a Phase I multicenter study that will be conducted in the United States and consists of a double-blind, placebo-controlled, SAD stage, followed by a double-blind, placebo controlled MAD stage. The study will be conducted in approximately 65 adult patients between 18 and 80 years old who have RA.

Inclusion Criteria:

1. SAD Stage

   • RA diagnosed according to the ACR
   • For patients taking anti-rheumatic therapies, receipt of a stable regimen prior to randomization
   • Previous treatment with biologic agents, including anti-TNF agents, permitted but discontinued for an appropriate washout period

2. MAD Stage (same as above with the addition of the following)

   • Failure of at least one biologic agent, defined as lack of or loss of response or intolerance
   • Active disease defined by swollen and tender count

Exclusion Criteria:

• Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty's syndrome
• Malignancy, or prior malignancy, other than non-melanoma skin cancer or cervical carcinoma in situ that has been resected
• History of treatment with any T cell-directed therapy