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| Sponsor: | University of Cincinnati |
|---|---|
| Collaborator: |
University of Chicago |
| Information provided by (Responsible Party): | Robert P Baughman, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00855205 |
Purpose
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 |
|---|---|---|
|
Sarcoidosis |
Drug: Rituximab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rituximab for Progressive Sarcoidosis |
| Estimated Enrollment: | 10 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Treatment with rituximab
|
Drug: Rituximab
Rituximab will be administered by IV infusion at a dose of 1000 mg (1 g) on day 1 and 15
|
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.
Eligibility| 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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Contacts and Locations| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| Principal Investigator: | Robert P Baughman, MD | University of Cincinnati |
More Information
| Responsible Party: | Robert P Baughman, Professor of Medicine, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00855205 History of Changes |
| Other Study ID Numbers: | 14889A |
| Study First Received: | March 3, 2009 |
| Last Updated: | November 2, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
pulmonary sarcoidosis |
|
Sarcoidosis Lymphoproliferative Disorders Lymphatic Diseases Rituximab Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |