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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid, Arthritis, Psoriatic, Ankylosing Spondylitis

In brief

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).

Key facts

Study ID

NCT00126724

Run by

Targeted Genetics Corporation

People needed

120

Starts

2005-08-01

Expected to finish

2009-05-01

Last updated by the study team

2009-07-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) diagnosed according to established criteria.
• Persistent moderate (grade 2) or severe (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection.
• For subjects with RA, an adequate trial of at least one disease-modifying drug (DMARD) prior to screening.
• For subjects currently on DMARD(s), a stable regimen of inflammatory arthritis for the previous three months, with no changes in doses four weeks prior to screening.
• Age greater than 18 years and less than 75 years at the time of screening.
• Willingness to practice effective birth control measures during the study (through week 36), if male or female of reproductive ability.
• Able to give written informed consent.

You may not qualify if…

• Disease severe enough to warrant a change in regimen for inflammatory arthritis in the next three months.
• Discontinuation of etanercept in the past because of safety concerns.
• Current use of anakinra (Kineret®)or abatacept (Orencia®).
• Corticosteroid therapy at doses higher than the equivalent of 10 mg prednisone per day.
• Steroid or hyaluronate injection in the target joint or receipt of an investigational agent less than four weeks prior to screening.
• Class IV ACR functional status (Hochberg et al., 1992).
• Any of the following laboratory values: Hemoglobin <8.5 gm/dL, white blood cell count <3500 per mm cube, platelet <100 K/uL, creatinine >2 mg/dL, bilirubin >2 mg/dL, AST or ALT >2 times the upper limit of normal, or abnormal coagulation profiles (>2 seconds beyond upper range of normal PT or PTT).
• Known HIV infection, known hepatitis C infection, or known positive serologic test for hepatitis B surface antigen.
• Positive PPD, unless previously treated with appropriate prophylaxis.
• Pregnancy or lactation, either at the time of screening or planned in the next 18 months.
• Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis.
• Serious medical disease, such as severe liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or uncontrolled asthma, demyelinating neurological disease, history of cancer (other than cutaneous basal and squamous cell carcinoma) with less than five years documentation of a disease-free state, insulin-dependent diabetes, recurrent opportunistic infections or other concurrent medical condition that, in the opinion of the investigator, would make the subject unsuitable for the study.
• Unlikely to comply with protocol.

Where it is running

• Sun Valley Arthritis Center — Glendale, Arizona, United States
• Catalina Pointe Clinical Research, Inc — Tuscon, Arizona, United States
• Desert Medical Advances — Palm Desert, California, United States
• Boling Clinical Trials — Upland, California, United States
• Denver Arthritis Research Center — Denver, Colorado, United States
• RASF-Clinical Research Center — Boca Raton, Florida, United States
• Ocala Rheumatology Research Center — Ocala, Florida, United States
• Radiant Research Stuart — Stuart, Florida, United States
• Coeur d'Alene Arthritis Clinic — Coeur d'Alene, Idaho, United States
• Northwestern Center for Clinical Research — Chicago, Illinois, United States
• The Arthritis Center — Springfield, Illinois, United States
• Arthritis and Osteoporosis Center of Maryland — Frederick, Maryland, United States
• Arthritis Center of Reno — Reno, Nevada, United States
• United Medical Associates — Johnson City, New York, United States
• Bone and Joint Hospital Research Dept. — Oklahoma City, Oklahoma, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Rheumatic Disease Associates — Willow Grove, Pennsylvania, United States
• Austin Rheumatology Research — Austin, Texas, United States
• Arthritis Consultation Center — Dallas, Texas, United States
• Metroplex Clinical Research Center — Dallas, Texas, United States
• Radiant Research San Antonio Northeast — San Antonio, Texas, United States
• Seattle Rheumatology Associates, PLLC — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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