CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2006 by Hospices Civils de Lyon.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Hospices Civils de Lyon
Information provided by:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT00399399
First received: November 13, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
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Purpose
To assess the efficacy of systemic corticosteroids alone as first-line treatment of Churg–Strauss syndrome without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse
| Condition | Intervention | Phase |
|---|---|---|
|
Churg-Strauss Syndrome |
Drug: azathioprine Drug: cyclophosphamide |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients. |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Eosinophilic Granulomatosis With Polyangiitis
ANCA-associated Vasculitis
U.S. FDA Resources
Further study details as provided by Hospices Civils de Lyon:
Primary Outcome Measures:
- Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)
Secondary Outcome Measures:
- Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
| Estimated Enrollment: | 72 |
| Study Start Date: | July 1996 |
All patients initially treated with systemic corticosteroids alone: optional IV methylprednisolone pulse (15 mg/kg) at treatment start followed by oral prednisone (1 mg/kg/day) according to a tapering schedule. Treating physicians allowed to treat minor relapses with corticosteroids without referring the patient for randomization, as long as the prednisone dose did not exceed 0.5 mg/kg for 1 month.
Patients in whom prednisone doses could not be tapered below 20 mg, those who failed to enter remission and those who relapsed were randomized to receive either 6 months of oral azathioprine (2mg/kg/day) or 6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month)
Eligibility| Ages Eligible for Study: | 15 Years to 90 Years (Child, Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women with newly diagnosed Churg-Strauss syndrome;
- absence of poor prognostic factors as defined by the five-factor score (serum creatinine > 140 μmol/l or 1.58 mg/dl, proteinuria > 1 g/day, severe gastrointestinal tract involvement, specific cardiomyopathy and/or central nervous system involvement;
- written informed consent.
Exclusion Criteria:
- age < 15 years, previously treated Churg-Strauss syndrome;
- history of cancer;
- pregnant or breast-feeding women;
- psychiatric disorders that might compromise compliance with therapy;
- contraindication to study drug;
- other ongoing therapeutic trial;
- concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00399399
Please refer to this study by its ClinicalTrials.gov identifier: NCT00399399
Locations
| Switzerland | |
| Camillo Ribi | |
| Geneva, Switzerland | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Jean-François Cordier, MD | Hospices Civils de Lyon |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00399399 History of Changes |
| Other Study ID Numbers: | 95.067 |
| Study First Received: | November 13, 2006 |
| Last Updated: | November 13, 2006 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hospices Civils de Lyon:
|
Churg-Strauss Vasculitis Therapy Cyclophosphamide Azathioprine |
Additional relevant MeSH terms:
|
Syndrome Churg-Strauss Syndrome Disease Pathologic Processes Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases Autoimmune Diseases Immune System Diseases |
Cyclophosphamide Azathioprine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antimetabolites Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on September 23, 2016