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Rituxan in Churg Strauss Syndrome With Renal Involvement

This study has been terminated.
(Company providing study drug terminated study due to lack of funds)
Sponsor:
Collaborators:
Genentech
Biogen Idec
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00424749
First received: January 19, 2007
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
Results First Received: September 12, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Churg-Strauss Syndrome
Interventions: Drug: Rituximab
Drug: Prednisone

  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
This study was done between June 2007 and July 2009. Participants were enrolled at the Mayo Clinic in Rochester, MN.

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
Rituximab 375 mg/m^2/week for 4 weeks

Participant Flow:   Overall Study
    Rituximab  
STARTED     4  
COMPLETED     3  
NOT COMPLETED     1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Rituximab 375 mg/m^2/week for 4 weeks

Baseline Measures
    Rituximab  
Number of Participants  
[units: participants]
 		  4  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     4  
>=65 years     0  
Gender  
[units: participants]
 		 
Female     2  
Male     2  
Region of Enrollment  
[units: participants]
 		 
United States     4  



  Outcome Measures
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1.  Primary:   Participants With Remission of Renal Disease Activity at 3 Months   [ Time Frame: 3 months after beginning of remission induction regimen ]
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2.  Secondary:   Participants With Normalization of Eosinophil Count at 6 Months   [ Time Frame: 6 months after beginning of remission induction regimen ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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
The limited number of individuals enrolled into the study makes it difficult to draw firm conclusions that are more than hypothesis generating. The company providing study drug terminated study due to lack of funds.  


Results Point of Contact:  
Name/Title: Dr. Fernando C. Fervenza
Organization: Mayo Clinic
e-mail: fervenza.fernando@mayo.edu


Publications of Results:


Responsible Party: Fernando Fervenza, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00424749     History of Changes
Other Study ID Numbers: 06-004767, UL1RR024150
Study First Received: January 19, 2007
Results First Received: September 12, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration