NCT00730717

Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wright State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Pyoderma Gangrenosum

Interventions

Type	Name	Description
DRUG	Humira	Will receive 80 mg of Humira injection at week 0 followed by 40 mg weekly Humira injection from Week 1 to Week 23
DRUG	Humira	Will receive 40 mg Humira injection every other week from Week 0 to Week 23

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-08-08
• Last updated: 2022-02-15

Locations

1 site across 1 country: United States