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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by:
Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT00690846
First received: June 2, 2008
Last updated: March 24, 2010
Last verified: June 2008
  Purpose

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


Condition Intervention Phase
Pyoderma Gangrenosum
Drug: adalimumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Mean change in the number of ulcers. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 5
Arms Assigned Interventions
Experimental: 1
40 mg weekly subcutaneous injection of adalimumab
Drug: adalimumab
40 mg weekly adalimumab injection.
Other Name: Humira

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00690846

Locations
United States, North Carolina
Wake Forest University Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Joseph Jorizzo, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Joseph Jorizzo, MD, Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00690846     History of Changes
Other Study ID Numbers: 00002156, 32410
Study First Received: June 2, 2008
Last Updated: March 24, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Pyoderma
Pyoderma Gangrenosum
Skin Diseases
Skin Diseases, Vascular
Skin Ulcer
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014