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

Rheumatoid Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718588
• Other study ID #: CDT4478g
• Status: Terminated
• Phase: Phase 1
• First received: July 16, 2008
• Last updated: March 6, 2012
• Start date: July 2008

Study information

• Verified date: March 2012
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• MTRX1011A
Subcutaneous and intravenous single and repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of MTRX1011A in both the SAD and MAD stages		Length of study	Yes
Secondary	Characterize the pharmacokinetic response of MTRX1011A		Length of study	Yes
Secondary	Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A		Length of study	Yes