Phase 1 Dose Escalation Study of Intra-Articular Administration of tgAAC94
Completed · Phase 1 · Has a placebo group
Conditions studied: Rheumatoid Arthritis
In brief
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.
Key facts
- Study ID
- NCT00617032
- Run by
- Targeted Genetics Corporation
- People needed
- 15
- Starts
- 2004-02-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2008-02-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- UCLA Division of Rheumatology — Los Angeles, California, United States
- Denver Arthritis Research Center — Denver, Colorado, United States
- Swedish Rheumoatology Research — Seattle, Washington, United States
- Arthritis Research Centre of Canada — Vancouver, British Columbia, Canada
- Arthritis Centre Clinical Research Unit UofManitoba — Winnipeg, Manitoba, Canada
- Mt Sinai Hospital — Toronto, Ontario, Canada
- Toronto Western Hospital — Toronto, Ontario, Canada
Full record on ClinicalTrials.gov
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