A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis
Phase 1
Terminated
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00718588
- Lead Sponsor
- Genentech, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 66
Inclusion Criteria
-
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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability of MTRX1011A in both the SAD and MAD stages Length of study
- Secondary Outcome Measures
Name Time Method Characterize the pharmacokinetic response of MTRX1011A Length of study Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A Length of study