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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:
ClinicalTrials.gov Identifier:
NCT00683930
First Posted: May 26, 2008
Last Update Posted: June 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aspreva Pharmaceuticals
Information provided by:
Hoffmann-La Roche
Results First Submitted: November 18, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 
Overall Participants Analyzed 
[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) 
[1] Intent-to-treat population
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 ]

2.  Secondary:   Time to Initial Response   [ Time Frame: up to 52 weeks ]

3.  Secondary:   Time to Sustained Response   [ Time Frame: up to 52 weeks ]

4.  Secondary:   Duration of Prednisone Maintenance Dosing   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00683930     History of Changes
Obsolete Identifiers: NCT00140127
Other Study ID Numbers: WX17796
First Submitted: May 19, 2008
First Posted: May 26, 2008
Results First Submitted: November 18, 2009
Results First Posted: June 22, 2011
Last Update Posted: June 22, 2011