Trial Outcomes & Findings for Rituxan in Churg Strauss Syndrome With Renal Involvement (NCT NCT00424749)

Results Overview

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)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

4 participants

Primary outcome timeframe

3 months after beginning of remission induction regimen

Results posted on

2011-12-08

Participant Flow

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

Participant milestones

Participant milestones
Measure	Rituximab 375 mg/m\^2/week for 4 weeks
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab 375 mg/m\^2/week for 4 weeks
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Rituxan in Churg Strauss Syndrome With Renal Involvement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab n=4 Participants 375 mg/m\^2/week for 4 weeks
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	2 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Region of Enrollment United States	4 participants n=93 Participants

PRIMARY outcome

Timeframe: 3 months after beginning of remission induction regimen

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)

Outcome measures

Outcome measures
Measure	Rituximab n=3 Participants 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.
Participants With Remission of Renal Disease Activity at 3 Months	3 participants

SECONDARY outcome

Timeframe: 6 months after beginning of remission induction regimen

Normalization of eosinophil counts was defined as total eosinophil counts \<1.5 x 10\^9/L.

Outcome measures

Outcome measures
Measure	Rituximab n=3 Participants 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.
Participants With Normalization of Eosinophil Count at 6 Months	2 participants

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Rituximab n=3 participants at risk 375 mg/m\^2/week for 4 weeks
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract Infection	33.3% 1/3 • Number of events 1 • 1 year after beginning of the remission induction regimen 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.

Additional Information

Dr. Fernando C. Fervenza

Mayo Clinic

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place