Trial of Adalimumab in Progressive Sarcoidosis
Sarcoidosis is a rare disease that can affect any organ in the body. It is characterized by the buildup of immune-system (fights off infection in the body) cells in organs. These cells form small groups called granulomas, which lead to inflammation of the surrounding tissue. Sarcoidosis most commonly affects the lung and the lymph nodes (part of the immune system). The signs usually include shortness of breath, fever, dry cough, and chest pain. Other signs in many patients can include redness and painful lumps on the skin, reduced eyesight, joint pain, and rarely, nervous system damage. Sarcoidosis commonly affects young and middle-aged adults.
There are no approved therapies for the treatment of sarcoidosis. Corticosteroid (steroid hormone) therapy is considered the standard treatment. Only limited benefit has been shown when using corticosteroid therapy to ease lung symptoms or improve lung function in patients with sarcoidosis. Also, the effects of other therapies (for example: methotrexate, cyclophosphamide, anti-malarial drugs, thalidomide) and other immunosuppressants (drugs that suppress a body's natural defense system [immune system]) which have been used in a small number of patients are not well known and can cause long term problems.
The drug used in this study is called adalimumab. Adalimumab is FDA (Food and Drug Administration) approved for patients with moderately to severely active rheumatoid arthritis. However, adalimumab is not approved for the treatment of sarcoidosis. Adalimumab is experimental in this study. The purpose of this study is to evaluate the safety and effectiveness of adalimumab in the treatment of patients with sarcoidosis with pulmonary (lung) involvement who show symptoms of the disease even though they are currently being treated with medication.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Prospective Open-Label Trial of Adalimumab in Progressive Sarcoidosis|
- The primary objective of this study is to evaluate the efficacy and safety of adalimumab, as measured by pulmonary function, in subjects with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment. [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- To evaluate the efficacy of adalimumab in improving the symptoms and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
- To assess the effect of adalimumab on quality of life in subjects with chronic sarcoidosis with pulmonary involvement [ Time Frame: 12 Weeks & 24 Weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||September 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00311246
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Nadera J. Sweiss, M.D.||The University of Chicago Hospitals|