Rituxan in Churg Strauss Syndrome With Renal Involvement

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00424749
• Date of registration: 19/01/2007
• Prospective Registration: Yes
• Primary sponsor: Fernando Fervenza
• Public title: Rituxan in Churg Strauss Syndrome With Renal Involvement
• Scientific title: A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement
• Date of first enrolment: June 2007
• Target sample size: 4
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00424749
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Fernando C. Fervenza, M.D., Ph.D.
• Affiliation: Mayo Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with Churg-Strauss syndrome as defined by meeting one of 3 sets of criteria
for Churg-Strauss Syndrome described above who have not yet been treated, who have
failed steroid therapy (partial or non-responders) or who can not been tapered off
oral prednisone because of documented relapsing disease

- Renal involvement (>25% dysmorphic red cell, red blood cell casts, or pauci-immune
glomerulonephritis on biopsy)

- Age >18 years old

- Serum creatinine less than or equal to 3.0 mg/dl

- Able and willing to give written informed consent and comply with the requirements of
the study protocol.

- Negative serum pregnancy test (for women of child bearing age)

- Men and women of reproductive potential must agree to use an acceptable method of
birth control during treatment and for twelve months after completion of treatment.

Exclusion Criteria

- Severe obstructive or restrictive lung disease (forced expiratory volume in one second
<1)

- Cerebral involvement

- Rapidly progressive optic neuropathy or retinal vasculitis

- Active gastrointestinal bleeding

- Heart failure, including pericarditis or myocarditis.

- Hemoglobin <8.5 gm/dL

- Platelets <100,000/mm

- AST or ALT >2.5 Upper Limit of Normal unless related to primary disease

- Positive Hepatitis B or C serology

- History of positive HIV testing

- Treatment with any investigational agent within 4 weeks of screening or 5 half-lives
of the investigational drug (whichever is longer)

- Previous treatment with Rituximab

- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
antibodies

- History of recurrent significant infection or history of recurrent bacterial
infections

- Known active bacterial, viral fungal mycobacterial, or other infection (including
tuberculosis or atypical mycobacterial disease, but excluding fungal infections of
nail beds) or any major episode of infection requiring hospitalization or treatment
with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks
prior to screening

- Lack of peripheral venous access

- History of drug, alcohol, or chemical abuse within 6 months prior to screening

- Pregnancy or lactation

- Concomitant malignancies or previous malignancies, with the exception of adequately
treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the
cervix

- Significant cardiac or pulmonary disease (including obstructive pulmonary disease)

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complications



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Churg-Strauss Syndrome

Intervention(s)

Drug: Prednisone

Drug: Rituximab

Primary Outcome(s)

Participants With Remission of Renal Disease Activity at 3 Months [Time Frame: 3 months after beginning of remission induction regimen]

Secondary Outcome(s)

Participants With Normalization of Eosinophil Count at 6 Months [Time Frame: 6 months after beginning of remission induction regimen]

Secondary ID(s)

06-004767

UL1RR024150

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Biogen

Genentech, Inc.

National Center for Research Resources (NCRR)

Results

• Results available: Yes
• Date Posted: 08/12/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00424749