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

Genentech

Status and phase

Terminated

Phase 1

Conditions

Rheumatoid Arthritis

Treatments

Drug: MTRX1011A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00718588

CDT4478g

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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