Trial of Adalimumab in Progressive Sarcoidosis

Inclusion Criteria:

* Men and women \> 18 years of age.
* Sarcoidosis diagnosed at least 1 year prior to screening.
* Histologically proven sarcoidosis prior to screening.
* Have a diagnosis of sarcoidosis with evidence of parenchymal disease on chest radiograph (Stage II or III) or Stage I disease by chest radiographs and evidence of abnormal PFT as below or normal chest radiograph; or abnormal PFT, with abnormal chest computed tomography (CT) and evidence of sarcoid lung involvement by histology. Subjects with concurrent extrapulmonary sarcoidosis, particularly skin and eye involvement, are encouraged to be enrolled.
* Have forced vital capacity (FVC) \> 40 and \< 80% of predicted.
* Have an American Thoracic Society (ATS) dyspnea score of \> Grade 1.
* Have been receiving pre-study treatment that includes at least 10 mg/day prednisone (or equivalent dose of corticosteroid) as a single agent, or 1 or more immunosuppressant (e.g., methotrexate, azathioprine, cyclophosphamide, chloroquine, leflunomide, hydroxychloroquine, mycophenolate mofetil, cyclosporine, tacrolimus, corticosteroids) for at least the 3-month period immediately prior to screening. Subjects must be on a stable dose of these medications for \> 4 weeks before starting the study medication.
* Adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) must be used for the duration of the study and such precautions should be continued for 6 months after receiving the last study agent injection.
* Are considered eligible based on TB screening

Exclusion Criteria:

* Have used any investigational drug within 1 month prior to screening.
* Have received previous administration of a treatment with any other therapeutic agent targeted at reducing tumor necrosis factor \[TNF\] (e.g., pentoxifylline, thalidomide, etanercept, infliximab) within 3 months prior to screening.
* Have received previous administration of adalimumab.
* Have received any live virus or bacterial vaccinations within the 3 months before the first dose of the study agent or are expected to receive any live virus or bacterial vaccinations during the trial or up to 3 months after the last dose of the study agent.
* Have had any previous adverse reactions or allergic reactions (e.g., anaphylaxis) associated with the administration of monoclonal antibodies.
* Have New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF).
* Have a history of severe right-sided heart failure or cor pulmonale.
* Have had serious infections within 2 months of screening. Less serious infections (such as acute upper respiratory tract infection \[colds\] or a simple urinary tract infection) need not be considered as exclusion at the discretion of the investigator.
* Are considered ineligible according to the United States of America (USA)-specific TB screening.
* Have or have had an opportunistic infection (e.g., herpes zoster \[shingles\], cytomegalovirus, Pneumocystis carinii, aspergillosis and aspergilloma, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
* Have a known infection with human immunodeficiency virus (HIV).
* Have current signs and symptoms of systemic lupus erythematosus, or severe, progressive, or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic, or cerebral diseases (with the exception of sarcoidosis).
* Presence of a transplanted organ (with the exception of a corneal transplant) \> 3 months prior to screening.
* Have any known malignancy or history of malignancy within 5 years prior to screening.
* Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease.
* Are pregnant, nursing, or planning pregnancy (both men and women) during the trial or within the 6-month period thereafter.
* Have had a known substance abuse or dependency, drug or alcohol within 3 years of screening.
* Have poor tolerability of subcutaneous injection or lack of adequate venous access for required blood sampling.
* Have a known history of demyelinating disease such as multiple sclerosis or optic neuritis.
* Presence of a non-sarcoidosis condition affecting survival.
* Have mental health problems interfering with participation.