Status:
COMPLETED
Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94
Lead Sponsor:
Targeted Genetics Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 arthrit...
Detailed Description
tgAAC94 is a recombinant adeno-associated virus serotype 2 (AAV2) vector genetically engineered to contain the cDNA for a human tumor necrosis factor receptor (TNFR)-immunoglobulin (IgG1) Fc fusion (T...
Eligibility Criteria
Inclusion
- Rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, diagnosed according to published criteria
- Persistent moderate (grade 2) or sever (grade 3) swelling due to inflammatory arthritis in at least one peripheral joint eligible for injection
- For subjects with rheumatoid arthritis, an adequate trial of at least one disease-modifying antirheumatic drug (DMARD) prior to screening
- For subjects currently on DMARD(s), a stable regimen for inflammatory arthritis for the previous three months, with no changes in doses in the four weeks prior to screening
- Age greater than 18 years
- Be willing to practice effective birth control measures during the study, if of reproductive ability
- Able to give written informed consent
Exclusion
- Current use of a TNF-alpha antagonist
- Disease severe enough to warrant use of a systemic TNF-alpha antagonist in the next three months
- Discontinuation of TNF-alpha antagonists in the past because of safety concerns
- Current use of anakinra
- Poor functional status, defined as being bed-bound or wheelchair-bound
- Corticosteriod therapy at doses higher than the equivalent of 10 mg prednisone per day
- Any of the following laboratory values: Hemoglobin \<8.5 gm/dL, white blood cell count \<3500 per mm\^3, platelet \<100 K/microL, creatinine \>2 mg/dL, bilirubin \>2 mg/dL, AST or ALT \>2 times the upper limit of normal, or abnormal coagulation profiles
- 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 six months
- Inflammatory bowel disease, such as Crohn's disease or ulcerative colitis
- Serious medical disease, such as sever liver or kidney disease, uncompensated congestive heart failure, myocardial infarction within six months, unstable angina, uncontrolled hypertension, severe pulmonary disease or active 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 the protocol
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00617032
Start Date
February 1 2004
End Date
November 1 2005
Last Update
February 15 2008
Active Locations (7)
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1
UCLA Division of Rheumatology
Los Angeles, California, United States
2
Denver Arthritis Research Center
Denver, Colorado, United States
3
Swedish Rheumoatology Research
Seattle, Washington, United States
4
Arthritis Research Centre of Canada
Vancouver, British Columbia, Canada