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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00718588
Recruitment Status : Terminated (Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.)
First Posted : July 18, 2008
Last Update Posted : March 7, 2012
Information provided by (Responsible Party):
Genentech, Inc.

July 16, 2008
July 18, 2008
March 7, 2012
July 2008
December 2009   (Final data collection date for primary outcome measure)
Safety and tolerability of MTRX1011A in both the SAD and MAD stages [ Time Frame: Length of study ]
Same as current
Complete list of historical versions of study NCT00718588 on Archive Site
  • 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 ]
Same as current
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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.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: MTRX1011A
Subcutaneous and intravenous single and repeating dose
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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United States
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Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: John Davis, M.D., M.P.H. Genentech, Inc.
Genentech, Inc.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP