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Sponsors and Collaborators: |
Pariser, Robert J., M.D. Abbott Virginia Clinical Research, Inc. |
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Information provided by: | Pariser, Robert J., M.D. |
ClinicalTrials.gov Identifier: | NCT00274352 |
The purpose of this study is to determine if adalimumab is an effective for the skin manifestations of sarcoidosis.
Condition | Intervention | Phase |
---|---|---|
Sarcoidosis |
Drug: adalimumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study of Adalimumab in the Treatment of Cutaneous Sarcoidosis |
Estimated Enrollment: | 30 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | May 2007 |
The cutaneous lesions of sarcoidosis are often disfiguring and can produce functional impairment. They tend to be hard to treat with most topical therapies and often require systemic medications which carry the risk of significant side effects. Often such treatments are withheld unless there is a need to use them for visceral involvement. There is thus an unmet need for safe and effective treatments for these patients. In addition there is essentially no controlled trial data for any treatments for cutaneous sarcoidosis. This study is intended to determine if adalimumab might offer a viable therapeutic option for this condition by comparing the response of cutaneous sarcoid lesions to this drug as compared to placebo.
Ages Eligible for Study: | 18 Years to 89 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject must have moderate to severe cutaneous sarcoidosis with chronic indurated lesions (papules, nodules, and/or plaques), which histopathologically show non-caseating granulomas with negative special stains for microorganisms (AFB and PAS or GMS). Accepted clinical variants include, but are not necessarily limited to the following:
For purposes of this study “moderate to severe cutaneous sarcoidosis” is defined as the presence of sarcoidal skin lesions with any of the following features:
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is using one of the following methods of birth control for the duration of the study and 90 days after study completion:
The following criteria for concomitant treatments of sarcoidosis must be met:
OR if a subject is on such topical or oral medications, the dose has been stable for these same time intervals and is likely to remain stable for the duration of the study. Patients whose non-cutaneous disease is being managed by other physicians will continue to have their care directed by these physicians. The managing physicians will be kept informed of the patients’ status, consistent with study blinding. If the patient’s dose of a concomitant systemic therapy for non-cutaneous sarcoidosis must change by more than 20% of the dose at study entry due to a change in medical condition during the double-blind phase, the subject will be discontinued from the study. During the open-label phase the need for a greater than 20% increase in dose of concomitant treatment for non-cutaneous sarcoidosis will be viewed as treatment failure and the patient will be discontinued from the study. Reduction of the dose of such treatment of any magnitude will not result in discontinuance. Continued use of intralesional therapies is not permitted. Inhaled corticosteroids for a stable medical condition are allowed.
Exclusion Criteria:
Subject has a variant of sarcoidosis that is not amenable to study evaluation, in the absence of chronic indurated lesions, such as:
Contact: Robert J Pariser, MD | 757-622-6315 | rpariser@pol.net |
United States, Virginia | |
Virginia Clinical Research, Inc. | Recruiting |
Norfolk, Virginia, United States, 23507 | |
Contact: Robert J Pariser, MD 757-625-0151 rpariser@pol.net | |
Contact: Pamela T Allen, CMA, CCRP 757 625 0151 paallen@virginiaclinicalreserach.com | |
Principal Investigator: Robert J Pariser, MD |
Principal Investigator: | Robert J Pariser, MD | Eastern Virginia Medical School |
Study ID Numbers: | HUM05-006 |
Study First Received: | January 6, 2006 |
Last Updated: | November 3, 2006 |
ClinicalTrials.gov Identifier: | NCT00274352 |
Health Authority: | United States: Food and Drug Administration |
sarcoidosis adalimumab skin diseases |
Lymphatic Diseases Skin Diseases Sarcoidosis Adalimumab Lymphoproliferative Disorders |
Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Pharmacologic Actions |