Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum (NCT00730717) | Clinical Trial Compass
WithdrawnPhase 2
Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum
United States0Started 2009-05
Plain-language summary
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subject is willing and able to give informed consent.
* Subject is willing and able to participate in the study as an outpatient and is willing to comply with study requirements.
* Subject is 18 years of age or older.
* Subject has a diagnosis of pyoderma gangrenosum that involves total area of 3 cm2 or greater and is of sufficient severity to warrant systemic agents.
* If female of childbearing potential, subject will have a negative urine pregnancy test at Screening and Week 0.
* If female, subject will be either post-menopausal for \> 1 year, surgically sterile (hysterectomy or bilateral tubal ligation), or practicing one form of birth control (abstinence, oral contraceptive, estrogen patch, implant contraception, injectable contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner). Female subjects will continue to use contraception for 6 months following the last injection.
* Screening laboratory results are within the following parameters:
* Hemoglobin \> 9 g/dL
* White blood cells \> 3.0 x 10 to the 9th power/L, \<14.0 x 10 to the 9th power/L (unless on oral corticosteroids and no signs/symptoms of infection)
* Neutrophils \> 1.5 x 10 to the 9th power/L
* Platelets \> 100 x 10 to the 9th power/L
* Lymphocytes \> 0.5 x 10 to the 9th power/L
* Serum creatinine within 1.5 times the upper limit of normal range
* AST and ALT within 2 times the upper limit of normal range
* Subject has been on a stable dose of…
What they're measuring
1
Mean change in the number of ulcers from baseline to the end of study
Timeframe: week 0, week 1, week 4 and then very 4 weeks until week 24.
2
Mean change in ulcer area from baseline to end of study
Timeframe: week 0, week 1, week 4 and then very 4 weeks until week 24.