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Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects

NCT00126724 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-07-29

No results posted yet for this study

Summary

The 13G01 clinical trial is a Phase I/II dose escalation study designed to be conducted in adults with inflammatory arthritis who have persistent moderate or severe swelling in one or more joints, without a disease severe enough to warrant a change in regimen for the next three months.

The study will permit subjects who are concurrently on anti-tumor necrosis factor (TNF)-alpha antagonists. For subjects on disease modifying antirheumatic drugs (DMARDs), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening will be required.

The primary objectives are:

1. to evaluate the safety of intra-articular administration of tgAAC94 in subjects currently taking TNF-alpha antagonists, and
2. to evaluate the safety of repeat intra-articular administration of tgAAC94 (gene therapy vector).

Conditions

Interventions

GENETIC

tgAAC94 gene therapy vector

Single Dose 1x10\^11 DRP/mL

GENETIC

tgAAC94 gene therapy vector

Second dose of 1x10\^11 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.

GENETIC

tgAAC94 placebo

placebo

GENETIC

tgAAC94 gene therapy vector

Single Dose 1x10\^12 DRP/mL tgAAC94

GENETIC

tgAAC94 gene therapy vector

Second dose of 1x10\^12 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.

GENETIC

tgAAC94 gene therapy vector

Single Dose 1x10\^13 DRP/mL tgAAC94

GENETIC

tgAAC94 gene therapy vector

Second dose of 1x10\^13 DRP/mL tgAAC94 administered once target joint reaches predetermined criteria for re-injection (on or after Week 12) at the same concentration as initial dose.

Sponsors & Collaborators

  • Targeted Genetics Corporation

    lead INDUSTRY

Principal Investigators

  • Alison Heald, MD · Targeted Genetics Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-10-31
Completion
2009-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00126724 on ClinicalTrials.gov