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.