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A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Patients With Active Pemphigus Vulgaris (PV)

This study has been completed.
Sponsor:
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00683930
First received: May 19, 2008
Last updated: May 25, 2011
Last verified: May 2011
History of Changes
Results First Received: November 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pemphigus Vulgaris (PV)
Interventions: Drug: Mycophenolate Mofetil 2 g/Day
Drug: Mycophenolate Mofetil (MMF) 3 g/Day
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/Day Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
MMF 3 g/Day Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks

Participant Flow:   Overall Study
    Placebo     MMF 2 g/Day     MMF 3 g/Day  
STARTED     36 [1]   21 [1]   37  
COMPLETED     29     18     28  
NOT COMPLETED     7     3     9  
[1] One subject not included: no study drug dispensed.



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/Day Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
MMF 3 g/Day Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks
Total Total of all reporting groups

Baseline Measures
    Placebo     MMF 2 g/Day     MMF 3 g/Day     Total  
Number of Participants  
[units: participants]
 		  36     21     37     94  
Age [1]
[units: years]
Mean ± Standard Deviation 		  45.8  ± 12.18     41.0  ± 15.59     44.8  ± 13.47     44.33  ± 13.45  
Gender [1]
[units: participants]
 		       
Female     24     14     18     56  
Male     12     7     19     38  
[1] Intent-to-treat population



  Outcome Measures
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1.  Primary:   Percentage of Patients Achieving Responder Status at Week 52   [ Time Frame: 52 weeks ]
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2.  Secondary:   Time to Initial Response   [ Time Frame: up to 52 weeks ]
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3.  Secondary:   Time to Sustained Response   [ Time Frame: up to 52 weeks ]
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4.  Secondary:   Duration of Prednisone Maintenance Dosing   [ Time Frame: 52 weeks ]
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  Serious Adverse Events
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Time Frame AEs were monitored throughout the course of the study. Further follow-up was made at approximately 24 weeks (±7 days) after the Week 52 visit to record any AEs that occurred during the follow-up period.
Additional Description Safety analysis population. Note one patient from both the placebo group and MMF 2g/day group were excluded from the safety population as no study drug was dispensed.

Reporting Groups
  Description
Placebo Placebo for Mycophenolate Mofetil (MMF) 2 g/day group: 4 tablets orally twice daily for 52 weeks; placebo for MMF 3 g/day group: 6 tablets orally twice daily for 52 weeks
MMF 2 g/Day Mycophenolate mofetil (MMF) 500 mg tablets; 4 tablets twice daily for 52 weeks
MMF 3 g/Day Mycophenolate mofetil (MMF) 500 mg tablets; 6 tablets twice daily for 52 weeks

Serious Adverse Events
    Placebo     MMF 2 g/Day     MMF 3 g/Day  
Total, serious adverse events        
# participants affected / at risk     4/36 (11.11%)     1/21 (4.76%)     3/37 (8.11%)  
Eye disorders        
Cataract † 1      
# participants affected / at risk     1/36 (2.78%)     0/21 (0.00%)     0/37 (0.00%)  
Gastrointestinal disorders        
Food Poisoning † 1      
# participants affected / at risk     1/36 (2.78%)     0/21 (0.00%)     0/37 (0.00%)  
Duodenal Ulcer † 1      
# participants affected / at risk     1/36 (2.78%)     0/21 (0.00%)     0/37 (0.00%)  
Pancreatitis † 1      
# participants affected / at risk     1/36 (2.78%)     0/21 (0.00%)     0/37 (0.00%)  
Infections and infestations        
Varicella † 1      
# participants affected / at risk     0/36 (0.00%)     0/21 (0.00%)     1/37 (2.70%)  
Musculoskeletal and connective tissue disorders        
Osteonecrosis † 1      
# participants affected / at risk     0/36 (0.00%)     0/21 (0.00%)     1/37 (2.70%)  
Nervous system disorders        
Cerebrovascular Accident † 1      
# participants affected / at risk     0/36 (0.00%)     1/21 (4.76%)     0/37 (0.00%)  
Pregnancy, puerperium and perinatal conditions        
Pregnancy † 1      
# participants affected / at risk     0/36 (0.00%)     0/21 (0.00%)     1/37 (2.70%)  
Abortion Spontaneous † 1      
# participants affected / at risk     0/36 (0.00%)     0/21 (0.00%)     1/37 (2.70%)  
Skin and subcutaneous tissue disorders        
Pemphigus † 1      
# participants affected / at risk     0/36 (0.00%)     0/21 (0.00%)     1/37 (2.70%)  
Vascular disorders        
Cardiovascular Insufficiency † 1      
# participants affected / at risk     1/36 (2.78%)     0/21 (0.00%)     0/37 (0.00%)  
† Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (9.1)




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:


Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00683930     History of Changes
Obsolete Identifiers: NCT00140127
Other Study ID Numbers: WX17796
Study First Received: May 19, 2008
Results First Received: November 18, 2009
Last Updated: May 25, 2011
Health Authority: United States: Food and Drug Administration