NCT00718588

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

1.4 years

First QC Date

July 16, 2008

Last Update Submit

March 6, 2012

Conditions

Rheumatoid Arthritis

Keywords

RA

Outcome Measures

Primary Outcomes (1)

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

    Length of study

Secondary Outcomes (2)

  • Characterize the pharmacokinetic response of MTRX1011A

    Length of study

  • Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A

    Length of study

Interventions

MTRX1011ADRUG

Subcutaneous and intravenous single and repeating dose

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • John Davis, M.D., M.P.H.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2008

First Posted

July 18, 2008

Study Start

July 1, 2008

Primary Completion

December 1, 2009

Last Updated

March 7, 2012

Record last verified: 2012-03