CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2006 by Hospices Civils de Lyon.
Recruitment status was: Active, not recruiting

Sponsor:

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

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: None (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:

Drug Information available for: Azathioprine

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

Detailed Description:

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)
Sexes Eligible for Study:	All
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

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: 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):

Samson M, Puéchal X, Devilliers H, Ribi C, Cohen P, Bienvenu B, Terrier B, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group (FVSG). Mononeuritis multiplex predicts the need for immunosuppressive or immunomodulatory drugs for EGPA, PAN and MPA patients without poor-prognosis factors. Autoimmun Rev. 2014 Sep;13(9):945-53. doi: 10.1016/j.autrev.2014.08.002. Epub 2014 Aug 19.

Samson M, Puéchal X, Devilliers H, Ribi C, Cohen P, Stern M, Pagnoux C, Mouthon L, Guillevin L; French Vasculitis Study Group. Long-term outcomes of 118 patients with eosinophilic granulomatosis with polyangiitis (Churg-Strauss syndrome) enrolled in two prospective trials. J Autoimmun. 2013 Jun;43:60-9. doi: 10.1016/j.jaut.2013.03.003. Epub 2013 Apr 13.

Ribi C, Cohen P, Pagnoux C, Mahr A, Arène JP, Lauque D, Puéchal X, Letellier P, Delaval P, Cordier JF, Guillevin L; French Vasculitis Study Group. Treatment of Churg-Strauss syndrome without poor-prognosis factors: a multicenter, prospective, randomized, open-label study of seventy-two patients. Arthritis Rheum. 2008 Feb;58(2):586-94. doi: 10.1002/art.23198.


ClinicalTrials.gov Identifier:	NCT00399399 History of Changes
Other Study ID Numbers:	95.067
Study First Received:	November 13, 2006
Last Updated:	November 13, 2006

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 August 17, 2017

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