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Infliximab in patients with chronic sarcoidosis with pulmonary involvement Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Infliximab in patients with chronic sarcoidosis with pulmonary involvement conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Infliximab in patients with chronic sarcoidosis with pulmonary involvement Clinical research trials and Infliximab in patients with chronic sarcoidosis with pulmonary involvement healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Infliximab in patients with chronic sarcoidosis with pulmonary involvement. Infliximab in patients with chronic sarcoidosis with pulmonary involvement Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Infliximab in patients with chronic sarcoidosis with pulmonary involvement clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Infliximab in patients with chronic sarcoidosis with pulmonary involvement condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "I" Clinical Trials Conditions > Infliximab in patients with chronic sarcoidosis with pulmonary involvement  Infliximab in patients with chronic sarcoidosis with pulmonary involvement
Infliximab in patients with chronic sarcoidosis with pulmonary involvement
For Condition: Sarcoidosis
Status: Recruiting
Sponsor(s): Centocor ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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 /= Grade 1 - Have been receiving prerandomization 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 (eg, 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 myocobacteria 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
Total Enrollment: 120
Location and Contact Information:
Additional Information:
Study ID Numbers: C0168T48;
Study Start Date: September 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073437
Other Sarcoidosis Studies:
1. Infliximab in patients with chronic sarcoidosis with pulmonary involvement
2. Role of Genetic Factors in the Development of Lung Disease
3. A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)
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Infliximab in patients with chronic sarcoidosis with pulmonary involvement
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