Rituxan in Churg Strauss Syndrome With Renal Involvement

• ClinicalTrials.gov Identifier: NCT00424749
• Recruitment Status: Terminated
• First Posted: January 22, 2007
• Results First Posted: December 8, 2011
• Last Update Posted: December 8, 2011
• Sponsor: Fernando Fervenza
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Rituximab
Arm/Group Description		375 mg/m^2/week for 4 weeks
Overall Number of Baseline Participants		4
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

Outcome Measures

1. Primary Outcome

Title	Participants With Remission of Renal Disease Activity at 3 Months
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rituximab
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Rituximab
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

Adverse Events

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
Arm/Group Description	375 mg/m^2/week for 4 weeks
All-Cause Mortality
	Rituximab
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Rituximab
	Affected / at Risk (%)	# Events
Total	0/3 (0.00%)
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.

Limitations and Caveats

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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Fernando C. Fervenza
• Organization: Mayo Clinic
• EMail: fervenza.fernando@mayo.edu

Publications of Results:

Cartin-Ceba R, Keogh KA, Specks U, Sethi S, Fervenza FC. Rituximab for the treatment of Churg-Strauss syndrome with renal involvement. Nephrol Dial Transplant. 2011 Sep;26(9):2865-71. doi: 10.1093/ndt/gfq852. Epub 2011 Feb 16.

• Responsible Party: Fernando Fervenza, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00424749
• 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