Status:
TERMINATED
A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis
Lead Sponsor:
Genentech, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00718588
Start Date
July 1 2008
Last Update
March 7 2012
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