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

This study has been terminated.
(Study had completed enrollment but drug injection was halted due to an unacceptable incidence of rash.)
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00718588
First received: July 16, 2008
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Drug: MTRX1011A
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety and tolerability of MTRX1011A in both the SAD and MAD stages [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetic response of MTRX1011A [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A [ Time Frame: Length of study ] [ Designated as safety issue: Yes ]

Enrollment: 66
Study Start Date: July 2008
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: MTRX1011A
    Subcutaneous and intravenous single and repeating dose
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718588

Sponsors and Collaborators
Genentech
Investigators
Study Director: John Davis, M.D., M.P.H. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00718588     History of Changes
Other Study ID Numbers: CDT4478g
Study First Received: July 16, 2008
Last Updated: March 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
RA

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

ClinicalTrials.gov processed this record on May 22, 2013