Clinical Trial: Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Multi Center, Open Label Pilot Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum

Brief Summary: The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.

Detailed Summary:

Pyoderma gangrenosum (PG) is an uncommon dermatosis that consists of nodules and pustules that ulcerate. PG can occur anywhere on the body. Lesions often progress in size and may be multiple. There is no universally accepted treatment for PG. In mild disease, therapy consists of local wound care and topical or intralesional corticosteroids. For more severe disease, systemic agents are necessary. Systemic corticosteroids are often effective, but large doses are required leading to serious long-term side effects. Other immunosuppressives have been reported to be successful in individual case reports and small case series. However, they too are associated with significant toxicities.

Infliximab is an antibody directed against TNF-α. It had been used in success for treatment of PG. Adalimumab (Humira) is a fully human antibody directed against TNF-α. Given that adalimumab has the same target as infliximab, one would expect that adalimumab may also be effective in the treatment of PG. Treatment with adalimumab may be advantageous over infliximab because it can be given at home, whereas infliximab is delivered intravenously in the office. Additionally, because adalimumab is fully human, patients would be less likely to form antibodies against the medication. Purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.


Sponsor: Wright State University

Current Primary Outcome:

  • 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. ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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. ]
  • 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 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 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 undermining score [ Time Frame: week 0, week 1, week 4 and then very 4 weeks until week 24. ]
  • 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. ]


Original Secondary Outcome: Same as current

Information By: Wright State University

Dates:
Date Received: August 4, 2008
Date Started: May 2009
Date Completion: December 2010
Last Updated: July 21, 2009
Last Verified: July 2009