Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333437
Status:
COMPLETED
Last Update Posted:
2013-11-13
First Post:
2006-06-02
Brief Title:
Pulmonary Involvement in Scleroderma A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Pulmonary Involvement in Scleroderma Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Researchers from the Division of Pulmonary and Critical Care Medicine at University of California San Francisco UCSF are conducting a study to evaluate whether mycophenolate mofetil an immunosuppressive medication trade named CellCept is safe and effective for preventing the lung damage from scleroderma from getting worse
Detailed Description:
The proposed study is designed to evaluate the safety and efficacy of mycophenolate mofetil CellCept for the treatment of symptomatic pulmonary alveolitis due to systemic sclerosis SSc This study utilizes a prospective open-label experimental design
Primary Hypothesis The alveolitis in patients with SSc as defined by decreased forced vital capacity FVC bronchoalveolar lavage BAL and High Resolution Chest Tomography HRCT is responsive to 1 year of daily mycophenolate mofetil therapy
Secondary Hypothesis Quality of life six-minute walk and single-breath diffusing capacity for carbon monoxide DLCO improve in patients with SSc mediated alveolitis after therapy with mycophenolate mofetil This response to therapy is associated with a change in the inflammatory cytokine profile present in BAL fluid
Primary Hypothesis The alveolitis in patients with SSc as defined by decreased forced vital capacity FVC bronchoalveolar lavage BAL and High Resolution Chest Tomography HRCT is responsive to 1 year of daily mycophenolate mofetil therapy
Secondary Hypothesis Quality of life six-minute walk and single-breath diffusing capacity for carbon monoxide DLCO improve in patients with SSc mediated alveolitis after therapy with mycophenolate mofetil This response to therapy is associated with a change in the inflammatory cytokine profile present in BAL fluid
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None