Clinical Trial: Rituximab for Pulmonary Sarcoidosis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Rituximab as a Novel Therapy in Refractory Sarcoidosis: A Prospective Open-
Brief Summary: 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.
Detailed Summary: 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.
Sponsor: University of Cincinnati
Current Primary Outcome:
- Adverse events by week 24 and by week 52 that are considered by the investigator to be reasonably or probably related to Rituximab. [ Time Frame: 1 year ]
- Change from baseline in 6-minute walk distance at Week 24 and 52. [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Borg's CR10 dyspnea score before 6 minute walk at weeks 12, 24, and 52 [ Time Frame: 1 year ]
- Change in FVC and percent of predicted FVC at weeks 24 and 52 [ Time Frame: 1 year ]
- To assess the effect of rituximab on B cell function as measured by markers of these cells in peripheral blood: CD19, CD27, IgD, and CD38 at baseline and weeks 24 and 52 and BAFF and IL-12p40 at baseline and weeks 12, 24, 36 and 52 [ Time Frame: 1 Year ]
Original Secondary Outcome: Same as current
Information By: University of Cincinnati
Dates:
Date Received: March 3, 2009
Date Started: July 2009
Date Completion:
Last Updated: December 9, 2013
Last Verified: December 2013
