Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum
This study has been withdrawn prior to enrollment.
(Dr. Jorizzo has decided to withdraw from this study due to the time it is taking to get the study started.)
Information provided by:
Wake Forest University
First received: June 2, 2008
Last updated: March 24, 2010
Last verified: June 2008
The purpose of this research study is to see if Humira (adalimumab) is effective and safe in the treatment of pyoderma gangrenosum.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multi-Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum (HUM 04-37)
Primary Outcome Measures:
- Mean change in the number of ulcers. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
40 mg weekly subcutaneous injection of adalimumab
40 mg weekly adalimumab injection.
Other Name: Humira
The primary objective of this study is to obtain preliminary data on the safety and efficacy of adalimumab for the treatment of PG. A secondary objective is to study gene expression in PG.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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:
- Subject has been on a stable dose of antibiotics, oral corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus, azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks
- Subject has evidence of a clinically significant, unstable or poorly controlled medical condition.
- Subject has a chest X-ray consistent with an active infection or previous exposure to TB and/or a positive purified protein derivative test at screening (>5 mm). (Subjects may participate if they are being actively treated in accordance with CDC guidelines.)
- Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This includes hepatitis B and C, and HIV.
- Subject has been hospitalized for infection or received IV antibiotics within the previous 2 months prior to baseline.
- Subject has clinical evidence as determined by the investigator of acutely infected pyoderma gangrenosum or subject is receiving systemic antibiotics for the treatment of acute infection. Subjects receiving minocycline, tetracycline, dapsone, or other antibiotics for anti-inflammatory purposes are permitted.
- Subject has a history of tuberculosis without documented adequate therapy.
- Subject has a history of a central nervous system disorder/demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis.
- Subject has current signs or symptoms or history of systemic lupus erythematosus.
- Subject has been diagnosed with a malignancy within the past 5 years except for successfully treated non-melanoma skin cancer.
- Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.
- Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).
- Subject has had a substance abuse problem within the previous 3 years.
- Subject has been treated with an anti-TNF biologic immune response modifier, such as infliximab, adalimumab, or etanercept within the past 8 weeks.
- Subject has any dermatologic disease in the target site that may be exacerbated by treatment or interfere with examination.
- Subject has been administered an investigational drug in another clinical study within 30 days prior to baseline (or 5 half-lives, whichever is longer).
- Subject has a known allergy to adalimumab.
- Subject is female and is pregnant, is considering becoming pregnant during the study and for 6 months afterwards, or is nursing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690846
|Wake Forest University Health Sciences Dermatology
|Winston Salem, North Carolina, United States, 27157 |
Wake Forest University
||Joseph Jorizzo, MD
||Wake Forest University
No publications provided
||Joseph Jorizzo, MD, Wake Forest University Health Sciences
History of Changes
|Other Study ID Numbers:
|Study First Received:
||June 2, 2008
||March 24, 2010
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Skin Diseases, Vascular