Safety and Efficacy Study of Humira in Treatment of Pyoderma Gangrenosum
Summary
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of pyoderma gangrenosum.
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.
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Pyoderma Gangrenosum
Intervention
Humira, Humira
Location
Stanford University
Stanford
California
United States
94305
Status
Withdrawn
Source
Wright State University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00730717
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Pyoderma Gangrenosum
An idiopathic, rapidly evolving, and severely debilitating disease occurring most commonly in association with chronic ulcerative colitis. It is characterized by the presence of boggy, purplish ulcers with undermined borders, appearing mostly on the legs. The majority of cases are in people between 40 and 60 years old. Its etiology is unknown.
Pyoderma
Any purulent skin disease (Dorland, 27th ed).
Ecthyma
An ulcerative pyoderma usually caused by group A beta-hemolytic streptococcal infection at the site of minor trauma. (Dorland, 27th ed)
Pyomyositis
An intramuscular suppuration of the large skeletal muscle groups. It is associated with INFECTION such as STAPHYLOCOCCUS AUREUS and PYODERMA. It was known as a tropical disease but is increasing among the immunocompromised (IMMUNOCOMPROMISED HOST). Symptoms include muscle pain, FEVER, and leucocytosis. It has been diagnosed by MRI SCANS.
Clinical Trials
Study to Determine the Safety and Efficacy of Adalimumab in the Treatment of Pyoderma Gangrenosum
The purpose of this research study is to see if Humira (adalimumab) is effective and safe in the treatment of pyoderma gangrenosum.
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum. This is a 6 month open label study of an...
This is a non-interventional, post-marketing, observational study (PMOS) in which HUMIRA® (adalimumab) is prescribed in the usual manner in accordance with the terms of the local marketin...
Surveillance of Humira Injection in Korean Patients
Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of...
Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?
Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that erosive damage may "heal" in some RA patients treated with anti-T...
PubMed Articles
Pyoderma gangrenosum is a rare ulcerative disorder of the skin of unknown etiology. We present a case of pyoderma gangrenosum that occurred following total knee arthroplasty, which was initially misdi...
Sunitinib Induced Pyoderma Gangrenosum-like Ulcerations.
Pyoderma gangrenosum is a non-infectious neutro?philic skin disease commonly associated with underlying systemic diseases. Histopathological and laboratory diagnostics are unspecific in the majority o...
Two percent topical phenytoin sodium solution in treating pyoderma gangrenosum: a cohort study.
Oral phenytoin is an extensively used medicine for the treatment of convulsive disorders. Topical phenytoin has also been used for various types of ulcers. To determine the effectiveness of 2% topical...
Citation Winger EE, Reed JL, Ashoush S, El-Toukhy T, Ahuja S, Taranissi M. Birth defect rates in women using Adalimumab (Humira(®) ) to treat immunologic-based infertility in IVF patients. Am J Repro...
Pyoderma gangrenosum is a rare autoinflammatory syndrome manifested by skin lesions eventually creating ulcers. Surgical management can lead to scarring and contracture at the site of the lesion due t...
