Subjects eligible for this study will have a diagnosis of sarcoidosis for a least one year prior to screening and have evidence of disease on chest X-ray. Sarcoidosis must also have been proven by biopsy. Subjects must be taking a minimum of 10 mg prednisone (or equivalent dose of steroid) per day or one or more immunosuppressants (methotrexate, azathioprine, etc.) for at least the three month period immediately prior to screening.

Condition	Treatment or Intervention	Phase
Sarcoidosis	Drug: Infliximab	Phase II

Further Study Details: 

Expected Total Enrollment:  120

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• Men and women >/= 18 years of age
• Onset of sarcoidosis at least one year prior to screening
• Histologically proven sarcoidosis
• Diagnosis of sarcoidosis with evidence of parenchymal disease on chest xray
• Have FVC >/=50 and </=85% of predicted
• Have an American Thoracic Society (ATS) dyspnea score of >/= Grade 1
• Have been receiving pre-randomization treatment that includes at least 10mg/day prednisone (or equivalent dose of corticosteroid), or 1 or more immunosuppressants (e.g., methotrexate, azathioprine, cyclophosphamide, chloroquine, hydroxychloroquine), for at least the 3 month period immediately prior to screening.
• Men and women of childbearing potential must use adequate birth control measures for the duration of the study and for 6 months after receiving the last study agent infusion

Exclusion Criteria

• Have used any investigational drug within 1 month prior to screening or within 5 half-lives of the investigational agent
• Have received previous administration of a treatment with any other therapeutic agent targeted at reducing TNF within 3 months prior to screening
• Have received previous administration of infliximab
• 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 or antibody fragments
• Have New York Heart Association (NYHA) Class III or IV congestive heart failure (CHF). (Note: Subjects with mild heart failure [NYHA Class I or II] should be closely monitored)
• Have a history of severe right-sided heart failure or cor pulmonale
• Have had serious infections (e.g., active hepatitis, pneumonia, or pyelonephritis) 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 an exclusion at the discretion of the investigator
• Are considered ineligible according to country-specific TB screening, eligibility assessment, and prevention rules defined in the protocol
• 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 (except for basal cell carcinoma of the skin that has been treated with no evidence of recurrence)
• Have a history of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (e.g., nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas, or splenomegaly. Subjects with enlarged lymph nodes or spleen consistent with sarcoidosis will not be excluded
• 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 [other than caffeine and/or nicotine]) within 3 years prior to screening
• Have poor tolerability of venipuncture or lack of adequate venous access for required blood sampling and infusion of study drug during the study period
• 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 the participation in the study

California
      Los Angeles,  California,  United States
Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  United States
Connecticut
      Farmington,  Connecticut,  United States
      New Haven,  Connecticut,  United States
District of Columbia
      Washington,  District of Columbia,  United States
Indiana
      Indianapolis,  Indiana,  United States
Iowa
      Iowa City,  Iowa,  United States
Maryland
      Baltimore,  Maryland,  United States
Massachusetts
      Boston,  Massachusetts,  United States
Minnesota
      Rochester,  Minnesota,  United States
      Minnesota Lung Center, Minneapolis,  Minnesota,  55407,  United States
New York
      New York City,  New York,  United States
      Pulmonary Research Associates, LLC, Larchmont,  New York,  10538,  United States
North Carolina
      Chapel Hill,  North Carolina,  United States
Ohio
      Cincinnati,  Ohio,  United States
      Cleveland,  Ohio,  United States
Pennsylvania
      Philadelphia,  Pennsylvania,  United States
      Philadelphia,  Pennsylvania,  United States
      Philadelphia,  Pennsylvania,  United States
South Carolina
      Spartanburg,  South Carolina,  United States
      Charleston,  South Carolina,  United States
Vermont
      Colchester,  Vermont,  United States
Washington
      Seattle,  Washington,  United States
Austria
      Pulmonologische Zentrum, Wien,  1140,  Austria
Belgium
      Yvoir,  Belgium
      General Hospital Middleheim, Antwerp,  2020,  Belgium
      University hospital Gathuisberg, Leuven,  3000,  Belgium
France
      Service de Pneumologie, Bobigny,  France
Germany
      Kentralklinik Bad Berka, Bad Berka,  99437,  Germany
      Ruhrlandklinik Heifhausen, ESSEN,  45239,  Germany
      Lungenklinik Heckeshorn, Berlin,  14109,  Germany
      Universitaetsklinik Freiburg, Freiburg,  79110,  Germany
Italy
      Opedale San Luigi, Orbassano (Torino),  10043,  Italy
      Padova,  Italy
Netherlands
      University Hospital Maastricht, Maastricht,  6229 HX,  Netherlands
      St. Antonius Hospital - Heart Lung Center Utrecht, Nieuwegein,  3435 CM,  Netherlands
      Erasmus MC Rotterdam, Rotterdam,  3015 GD,  Netherlands
Sweden
      Stockholm,  Sweden
Switzerland
      kantonsspital Basel, Basel,  CH-4031,  Switzerland
      Inselspital Bern, Bern,  CH-3010,  Switzerland
United Kingdom
      Royal Brompton Hospital, London,  SW3 6NP,  United Kingdom

Study ID Numbers:  C0168T48
Record last reviewed:  June 2004
Last Updated:  March 25, 2005
Record first received:  November 20, 2003
ClinicalTrials.gov Identifier:  NCT00073437
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08