N/A
N=7
Pulmonary Involvement in Scleroderma: A Clinical Study of the Safety and Efficacy of Mycophenolate Mofetil in Scleroderma Patients With Lung Involvement
Scleroderma, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT00333437 ↗Enrolled (actual)
7
Serious AEs
14.3%
Results posted
May 2013
Primary outcome: Primary: Mean Change From Baseline in Forced Vital Capacity (FVC) — 0.1786 Liters — p=0.026
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mycophenolate mofetil (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Forced Vital Capacity (FVC) |
0.1786 | 0.026 sig |
| SECONDARY Mean Change in Bronchoalveolar Lavage (BAL) Components (Neutrophils, Eosinophils) |
-3; -6.3 | 0.3652 |
| SECONDARY Change in Shortness of Breath (Self-reported) |
6; 1; 0 | — |
| SECONDARY Mean Change in Six Minute Walk Distance |
264.3 | 0.0115 sig |
| SECONDARY Mean Change in Diffusion Capacity of the Lung for Carbon Monoxide (DLCO) |
1.86 | 0.0167 sig |
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.
Eligibility Criteria
Inclusion Criteria
- To participate in this study, patients must first undergo a BAL and HRCT. To be eligible to undergo HRCT and BAL (under the purview of this trial), prospective patients must meet the following criteria:
- Aged 21-70.
- Negative pregnancy test (with a sensitivity of at least 50 mIU/mL) for females of child-bearing potential
- All patients must fulfill the criteria for SSc by American College of Rheumatology (ACR) criteria (Subcommittee for Scleroderma Criteria 1980).
- FVC 10 mg per day.
- Does not have ≥ 3.0% neutrophils or ≥ 2.0% eosinophils on screening BAL fluid and does not have ground glass opacification on HRCT.
- Unable to take oral medication.
- Not able to comply with study procedures in the opinion of the investigator.
Data sourced from ClinicalTrials.gov (NCT00333437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.