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

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

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.

Study Overview

• Status: Terminated
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: MTRX1011A

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of MTRX1011A in both the SAD and MAD stages	Length of study

Secondary Outcome Measures

Outcome Measure	Time Frame
Characterize the pharmacokinetic response of MTRX1011A	Length of study
Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A	Length of study

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: John Davis, M.D., M.P.H., Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: July 16, 2008
• First Submitted That Met QC Criteria: July 16, 2008
• First Posted (Estimate): July 18, 2008

Study Record Updates

• Last Update Posted (Estimate): March 7, 2012
• Last Update Submitted That Met QC Criteria: March 6, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: RA
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: CDT4478g