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

NCT00399399 | Unknown Phase 4

• 1 other identifier: 95.067
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Churg-Strauss Syndrome

Keywords

Churg-Strauss; Vasculitis; Therapy; Cyclophosphamide; Azathioprine

Outcome Measures

Primary Outcomes (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 Outcomes (1)

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

Interventions

azathioprine DRUG

cyclophosphamide DRUG

Eligibility Criteria

• Age: 15 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Camillo Ribi

Geneva, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 25153486 DERIVED

• 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.

  PMID: 23590801 DERIVED

• 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.

  PMID: 18240234 DERIVED

MeSH Terms

Conditions

Churg-Strauss Syndrome; Vasculitis

Interventions

Azathioprine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Jean-François Cordier, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: July 1, 1996
• Last Updated: November 14, 2006

Record last verified: 2006-11

Locations

CH (1)