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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00730717
Date of registration: 04/08/2008
Prospective Registration: Yes
Primary sponsor: Wright State University
Public title: Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum
Scientific title: Multi Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum
Date of first enrolment: May 2009
Target sample size: 20
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT00730717
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Name:     David F Fiorentino, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Stanford University
Key inclusion & exclusion 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:

- 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 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Pyoderma Gangrenosum
Intervention(s)
Drug: Humira
Primary Outcome(s)
Mean change in the number of ulcers from baseline to the end of study [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Mean change in ulcer area from baseline to end of study [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Secondary Outcome(s)
Change in dose of antibiotics and immunosuppressives used to treat PG [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Mean change in subject's evaluation of pain by visual analogue scale [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Mean change in subject's evaluation of severity measured by visual analogue scale [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Mean change in the number of ulcer by visit [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Mean change in the ulcer area from baseline by visit [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Mean change in undermining score [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Number of complete responders, partial responders, minimal responders and non-responders at the end of study. [Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24.]
Secondary ID(s)
HUM 04-37
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Stanford University
Wake Forest School of Medicine
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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