Expired Study
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Winston-Salem, North Carolina 27157


Purpose:

The purpose of this research study is to see if Humira (adalimumab) is effective and safe in the treatment of pyoderma gangrenosum.


Study summary:

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.


Criteria:

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: - 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 Exclusion Criteria: - 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.


Study is Available At:


Original ID:

IRB00002156


NCT ID:

NCT00690846


Secondary ID:

32410


Study Acronym:


Brief Title:

Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum


Official Title:

A Multi-Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum (HUM 04-37)


Overall Status:

Withdrawn


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Wake Forest University Health Sciences


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Dr. Jorizzo has decided to withdraw from thi


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joseph Jorizzo, MD
Principal Investigator
Wake Forest University Health Sciences

Study Dates

Start Date:July 2007
Completion Date:July 2007
Completion Type:Anticipated
Primary Completion Date:July 2007
Primary Completion Type:Anticipated
Verification Date:July 2018
Last Changed Date:July 30, 2018
First Received Date:June 2, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:Mean change in the number of ulcers.
Time Frame:24 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:adalimumab
Description:40 mg weekly adalimumab injection.
Arm Name:1
Other Name:Humira

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:40 mg weekly subcutaneous injection of adalimumab

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Wake Forest University Health Sciences

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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