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Clinical Trials/NCT00718588
NCT00718588TerminatedPhase 1

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

Genentech, Inc.0 sites66 target enrollmentStarted: July 1, 2008Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Terminated
Enrollment
66
Primary Endpoint
Safety and tolerability of MTRX1011A in both the SAD and MAD stages
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Arms & Interventions

Untitled Study

Intervention: MTRX1011A (Drug)

Outcomes

Primary Outcomes

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

Time Frame: Length of study

Secondary Outcomes

  • Characterize the pharmacokinetic response of MTRX1011A(Length of study)
  • Characterize the pharmacodynamic profile of single and multiple doses of MTRX1011A(Length of study)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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