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

• ClinicalTrials.gov Identifier: NCT00399399
• Recruitment Status: Unknown
• First Posted: November 14, 2006
• Last Update Posted: November 14, 2006
• Sponsor: Hospices Civils de Lyon
• Information provided by: Hospices Civils de Lyon

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Churg-Strauss Syndrome	Drug: azathioprine; Drug: cyclophosphamide	Phase 4

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 72 participants
• 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.
• Study Start Date: July 1996

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 90 Years (Child, Adult, Older Adult)
• 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

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, Puechal 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, Puechal 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, Arene JP, Lauque D, Puechal 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
• Other Study ID Numbers: 95.067
• First Posted: November 14, 2006
• Last Update Posted: November 14, 2006
• Last Verified: November 2006

Keywords provided by Hospices Civils de Lyon:

Churg-Strauss; Vasculitis; Therapy; Cyclophosphamide; Azathioprine

Additional relevant MeSH terms:

Churg-Strauss Syndrome; 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