Trial record 4 of 21 for:    "Churg Strauss syndrome"

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
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
  Purpose

Churg-Strauss Syndrome (CSS) is a disease characterized by asthma, abnormally high amounts of eosinophils (a type of white blood cell), and blood vessel inflammation. About 25% of CSS patients develop kidney disease. The goal of this pilot study was to evaluate the safety and effectiveness of Rituximab in inducing remission of kidney disease in patients with CSS.


Condition Intervention Phase
Churg-Strauss Syndrome
Drug: Rituximab
Drug: Prednisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study on the Use of Rituximab in the Treatment of Churg- Strauss Syndrome With Renal Involvement

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Participants With Remission of Renal Disease Activity at 3 Months [ Time Frame: 3 months after beginning of remission induction regimen ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • Participants With Normalization of Eosinophil Count at 6 Months [ Time Frame: 6 months after beginning of remission induction regimen ] [ Designated as safety issue: No ]
    Normalization of eosinophil counts was defined as total eosinophil counts <1.5 x 10^9/L.


Enrollment: 4
Study Start Date: June 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rituximab
375 mg/m^2/week for 4 weeks
Drug: Rituximab
Patients received 4 weekly doses of rituximab 375 mg/m^2.
Other Names:
  • Rituxan
  • MabThera
Drug: Prednisone
Prednisone 1 mg/kg/day (not to exceed 80 mg/day) for 4 weeks followed by a taper to 0 mg by 6 months
Other Names:
  • Deltasone
  • Liquid Pred
  • Meticorten
  • Orasone
  • Prednicen-M
  • Prednicot
  • Sterapred
  • Sterapred DS

Detailed Description:

Churg-Strauss syndrome (CSS) is a small vessel systemic vasculitis associated with asthma and eosinophilia that causes glomerulonephritis in about 25% of patients. Rituximab is a chimeric anti-CD20 monoclonal antibody that depletes B cells and is effective in numerous autoimmune disease including antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The aim of this study was to evaluate the safety and efficacy of Rituximab in inducing remission of renal disease activity in patients with CSS.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424749

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Fernando Fervenza
Genentech
Biogen Idec
Investigators
Principal Investigator: Fernando C. Fervenza, M.D., Ph.D. Mayo Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Fernando Fervenza, MD, PhD, Professor of Medicine, 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

Keywords provided by Mayo Clinic:
Antineutrophil cytoplasmic antibody associated vasculitis
Glomerulonephritis
Rituximab

Additional relevant MeSH terms:
Churg-Strauss Syndrome
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Rituximab
Antibodies, Antineutrophil Cytoplasmic
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 21, 2014