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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00718588
• Date of registration: 16/07/2008
• Prospective Registration: No
• Primary sponsor: Genentech, Inc.
• Public title: A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis
• Scientific title: 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
• Date of first enrolment: July 2008
• Target sample size: 66
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00718588
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: John Davis, M.D., M.P.H.
• Affiliation: Genentech, Inc.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: MTRX1011A

Primary Outcome(s)

Safety and tolerability of MTRX1011A in both the SAD and MAD stages [Time Frame: Length of study]

Secondary Outcome(s)

Characterize the pharmacokinetic response of MTRX1011A [Time Frame: Length of study]

Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A [Time Frame: Length of study]

Secondary ID(s)

CDT4478g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors