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Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94

NCT00617032 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-02-15

No results posted yet for this study

Summary

Study 1304 is a Phase I dose escalation study conducted in adults with persistent moderate (grade 2) or severe (grade 3) swelling due to inflammatory arthritis (rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis) in at least one peripheral joint eligible for injection. Disease must not be severe enough to warrant use of a TNF-alpha antagonist in the next three months.

Current use of TNF-alpha antagonists is not permitted. Subjects with rheumatoid arthritis must have had an adequate trial of at least one disease-modifying antirheumatic drug (DMARD) prior to screening.

The primary objective is to evaluate the safety of intra-articular administration of tgAAC94.

Conditions

Interventions

GENETIC

tgAAC94 gene therapy vector

Single Dose 1x10\^10 DNase resistant particles (DRP) / mL joint volume

GENETIC

tgAAC94 gene therapy vector

Single dose 1x10\^11 DNase resistant particles (DRP) / mL joint volume

GENETIC

tgAAC94 placebo

Single 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
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-11-30
Completion
2005-11-30

Countries

  • United States
  • Canada

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 NCT00617032 on ClinicalTrials.gov