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Trial record 2 of 5 for:    "Churg-Strauss Syndrome" | "glucocorticoids"

Rituxan in Churg Strauss Syndrome With Renal Involvement

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ClinicalTrials.gov Identifier: NCT00424749
Recruitment Status : Terminated (Company providing study drug terminated study due to lack of funds)
First Posted : January 22, 2007
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
Sponsor:
Collaborators:
Genentech, Inc.
Biogen
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Fernando Fervenza, Mayo Clinic

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Churg-Strauss Syndrome
Interventions Drug: Rituximab
Drug: Prednisone
Enrollment 4
Recruitment Details This study was done between June 2007 and July 2009. Participants were enrolled at the Mayo Clinic in Rochester, MN.
Pre-assignment Details  
Arm/Group Title Rituximab
Hide Arm/Group Description 375 mg/m^2/week for 4 weeks
Period Title: Overall Study
Started 4
Completed 3
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Rituximab
Hide Arm/Group Description 375 mg/m^2/week for 4 weeks
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
2
  50.0%
Male
2
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Participants With Remission of Renal Disease Activity at 3 Months
Hide Description Remission of renal disease activity was indicated by stable or falling creatinine, absence of active urinary sediment AND reduction of oral prednisone dose to less than 50% of average dose of preceding 3 months or less than 10 mg/day (whichever smaller)
Time Frame 3 months after beginning of remission induction regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab
Hide Arm/Group Description:
The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
3
2.Secondary Outcome
Title Participants With Normalization of Eosinophil Count at 6 Months
Hide Description Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.
Time Frame 6 months after beginning of remission induction regimen
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rituximab
Hide Arm/Group Description:
The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: participants
2
Time Frame 1 year after beginning of the remission induction regimen
Adverse Event Reporting Description Safety was assessed by monitoring and recording of adverse events, defined as any untoward medical occurrences in a patient participating in the trial, regardless of causality assessment.
 
Arm/Group Title Rituximab
Hide Arm/Group Description 375 mg/m^2/week for 4 weeks
All-Cause Mortality
Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Rituximab
Affected / at Risk (%) # Events
Total   0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rituximab
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Respiratory, thoracic and mediastinal disorders   
Upper Respiratory Tract Infection  [1]  1/3 (33.33%)  1
Indicates events were collected by systematic assessment
[1]
Participant was treated with oral antibiotic therapy and recovered.
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Fernando C. Fervenza
Organization: Mayo Clinic
EMail: fervenza.fernando@mayo.edu
Layout table for additonal information
Responsible Party: Fernando Fervenza, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00424749     History of Changes
Other Study ID Numbers: 06-004767
UL1RR024150 ( U.S. NIH Grant/Contract )
First Submitted: January 19, 2007
First Posted: January 22, 2007
Results First Submitted: September 12, 2011
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011