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Sponsors and Collaborators: |
University of Cincinnati University of Chicago |
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Information provided by: | University of Cincinnati |
ClinicalTrials.gov Identifier: | NCT00855205 |
Sarcoidosis is a inflammatory disease affecting many parts of the body, especially the lungs. While most patients do well, there is a group of patients who require continuous doses of prednisone or other drugs. The current study will determine the role of Rituximab as new agent for patients with refractory disease.
Condition | Intervention | Phase |
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Sarcoidosis |
Drug: Rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Rituximab for Progressive Sarcoidosis |
Estimated Enrollment: | 10 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment: Experimental
Treatment with rituximab
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Drug: Rituximab
Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15
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Patients with refractory pulmonary sarcoidosis will be eligible for participation in this open label trial of Rituximab as additional therapy. The study will evaluate the efficacy of rituximab in improving the symptoms and functional capacity in patients with chronic sarcoidosis with pulmonary involvement who are symptomatic despite current treatment.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Laboratory Exclusion Criteria
General Safety Exclusion Criteria
Inability to comply with study and follow-up procedures
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Contact: Robert P Baughman, MD | 513-584-5225 | bob.baughman@uc.edu |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45267 |
Principal Investigator: | Robert P Baughman, MD | University of Cincinnati |
Responsible Party: | University of Cincinnati ( Robert P Baughman ) |
Study ID Numbers: | 14889A |
Study First Received: | March 3, 2009 |
Last Updated: | March 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00855205 History of Changes |
Health Authority: | United States: Food and Drug Administration |
pulmonary sarcoidosis |
Lymphatic Diseases Immunologic Factors Rituximab Sarcoidosis |
Antirheumatic Agents Lymphoproliferative Disorders Sarcoidosis, Pulmonary |
Lymphatic Diseases Immunologic Factors Antineoplastic Agents Rituximab Therapeutic Uses |
Physiological Effects of Drugs Sarcoidosis Antirheumatic Agents Lymphoproliferative Disorders Pharmacologic Actions |