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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

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