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| Sponsor: | Wake Forest University |
|---|---|
| Information provided by: | Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT00690846 |
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 II |
| 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) |
| 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
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences Dermatology | |
| Winston Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Joseph Jorizzo, MD | Wake Forest University |
More Information
| 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 |
|
Pyoderma Pyoderma Gangrenosum Skin Diseases Skin Diseases, Vascular Skin Ulcer |
Adalimumab Antirheumatic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents |