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.

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MTRX1011A Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : July 2008
Actual Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Intervention Details:
    Drug: MTRX1011A
    Subcutaneous and intravenous single and repeating dose

Primary Outcome Measures :
  1. Safety and tolerability of MTRX1011A in both the SAD and MAD stages [ Time Frame: Length of study ]

Secondary Outcome Measures :
  1. Characterize the pharmacokinetic response of MTRX1011A [ Time Frame: Length of study ]
  2. Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A [ Time Frame: Length of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00718588

Sponsors and Collaborators
Genentech, Inc.
Study Director: John Davis, M.D., M.P.H. Genentech, Inc.

Responsible Party: Genentech, Inc. Identifier: NCT00718588     History of Changes
Other Study ID Numbers: CDT4478g
First Posted: July 18, 2008    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases