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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MTRX1011A
Sponsored by
Genentech, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring RA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Safety and tolerability of MTRX1011A in both the SAD and MAD stages

    Secondary Outcome Measures

    Characterize the pharmacokinetic response of MTRX1011A
    Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A

    Full Information

    First Posted
    July 16, 2008
    Last Updated
    March 6, 2012
    Sponsor
    Genentech, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00718588
    Brief Title
    A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of MTRX1011A in Patients With Rheumatoid Arthritis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Terminated
    Why Stopped
    Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    December 2009 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genentech, Inc.

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis
    Keywords
    RA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    66 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    MTRX1011A
    Intervention Description
    Subcutaneous and intravenous single and repeating dose
    Primary Outcome Measure Information:
    Title
    Safety and tolerability of MTRX1011A in both the SAD and MAD stages
    Time Frame
    Length of study
    Secondary Outcome Measure Information:
    Title
    Characterize the pharmacokinetic response of MTRX1011A
    Time Frame
    Length of study
    Title
    Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A
    Time Frame
    Length of study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John Davis, M.D., M.P.H.
    Organizational Affiliation
    Genentech, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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