Study of Intra-articular Delivery of tgAAC94 in Inflammatory Arthritis Subjects
Public ClinicalTrials.gov record NCT00126724. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase I/II Study of Repeat Intra-articular Administration of tgAAC94, a Recombinant Adeno-Associated Vector Containing the TNFR:Fc Fusion Gene, in Inflammatory Arthritis Subjects With and Without Concurrent TNF-alpha Antagonists
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT00126724
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 120 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 2005 (Type not available)
- Primary completion
- Oct 2008 (Actual)
- Completion
- May 2009 (Actual)
- Last update posted
- Jul 29, 2009
2005 – 2009
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sun Valley Arthritis Center | Glendale | Arizona | 85308 | — |
| Catalina Pointe Clinical Research, Inc | Tuscon | Arizona | 85704 | — |
| Desert Medical Advances | Palm Desert | California | 92260 | — |
| Boling Clinical Trials | Upland | California | 91786 | — |
| Denver Arthritis Research Center | Denver | Colorado | 80230 | — |
| RASF-Clinical Research Center | Boca Raton | Florida | 33486 | — |
| Ocala Rheumatology Research Center | Ocala | Florida | 34474 | — |
| Radiant Research Stuart | Stuart | Florida | 34996 | — |
| Coeur d'Alene Arthritis Clinic | Coeur d'Alene | Idaho | 83814 | — |
| Northwestern Center for Clinical Research | Chicago | Illinois | 60611 | — |
| The Arthritis Center | Springfield | Illinois | 62704 | — |
| Arthritis and Osteoporosis Center of Maryland | Frederick | Maryland | 21702 | — |
| Arthritis Center of Reno | Reno | Nevada | 89502 | — |
| United Medical Associates | Johnson City | New York | 13790 | — |
| Bone and Joint Hospital Research Dept. | Oklahoma City | Oklahoma | 73103 | — |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | 16635 | — |
| Rheumatic Disease Associates | Willow Grove | Pennsylvania | 19090 | — |
| Austin Rheumatology Research | Austin | Texas | 78705 | — |
| Arthritis Consultation Center | Dallas | Texas | 75231 | — |
| Metroplex Clinical Research Center | Dallas | Texas | 75235 | — |
| Radiant Research San Antonio Northeast | San Antonio | Texas | 78217 | — |
| Seattle Rheumatology Associates, PLLC | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00126724, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 29, 2009 · Synced Nov 11, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00126724 live on ClinicalTrials.gov.