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Sponsors and Collaborators: |
Wright State University Stanford University Wake Forest University |
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Information provided by: | Wright State University |
ClinicalTrials.gov Identifier: | NCT00731757 |
The purpose of this study is to determine the safety and efficacy of Humira in the treatment of cutaneous sarcoidosis.
Condition | Intervention | Phase |
---|---|---|
Sarcoidosis Cutaneous Sarcoidosis |
Drug: Humira |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II, Multi-Center, Open Label Study to Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Patients being treated with Humira.
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Drug: Humira
80 mg at week 0, then 40 mg weekly from week 1-week 23.
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Sarcoidosis is a multisystem disease. Cutaneous involvement occurs in approximately 25% of patients with lesion morphologies varying widely. There is no universally accepted treatment for sarcoidosis. Systemic agents such as oral corticosteroids are frequently necessary for treatment, but long-term therapy is limited by a multitude of serious adverse effects. Steroid-sparing agents such as methotrexate, azathioprine, anti-malarials, pentoxifylline, allopurinol, and thalidomide have been shown beneficial for select patients, but are limited due to significant toxicities of their own or inconsistencies in efficacy.
Infliximab is a chimeric, monoclonal antibody directed against TNF-α and is currently approved by the US Food and Drug Administration (FDA) to treat rheumatoid arthritis, ankylosing spondylitis, and Crohn's disease. Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding domain of the human TNF receptor linked to the Fc portion of human IgG1. Etanercept has been approved for the treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis. Treatment with infliximab and etanercept was generally well tolerated and safe in these reports.
To date, there have been no reports describing the treatment of sarcoidosis with adalimumab. Adalimumab (Humira; Abbott Laboratories, Abbot Park, IL) is a fully human, monoclonal antibody directed against TNF-α and is approved by the US FDA to treat rheumatoid arthritis. Given that adalimumab targets the same cytokine as infliximab and etanercept, one would expect that adalimumab may also be effective in the treatment of sarcoidosis. Treatment with adalimumab is advantageous over infliximab through differences in drug delivery. Infliximab is delivered intravenously in the office. This requires routine office visits and vital sign monitoring by a health care professional.
Adalimumab, on the other hand, is administered subcutaneously once weekly or every other week by the patient at home. Patients can be instructed on proper injection technique during one nurse visit. Additionally, because adalimumab is fully human, patients may be less likely to form antibodies against the medication. Because of the lack of alternative safe, effective treatment for sarcoidosis, a clinical trial to evaluate the efficacy of adalimumab in the treatment of sarcoidosis is warranted.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a physician global assessment score of at least 4. Diagnosis (based on the recommendations of an expert panel 24) can be made by either:
Screening laboratory results are within the following parameters:
Exclusion Criteria:
Contact: Michael Heffernan, MD | 937-224-7546 | michael.heffernan@wrightstatephysicians.org |
Contact: Caroline McNicholas | 937-528-7267 | caroline.mcnicholas@wrightstatephysicians.org |
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, North Carolina | |
Wake Forest University | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Michael P Heffernan, MD | Wright State University |
Responsible Party: | Wright State University School of Medicine, Department of Dermatology ( Michael P Heffernan, MD ) |
Study ID Numbers: | HUM 04-36 |
Study First Received: | August 6, 2008 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00731757 |
Health Authority: | United States: Food and Drug Administration |
Lymphatic Diseases Sarcoidosis Adalimumab Lymphoproliferative Disorders |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |