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CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400075
Recruitment Status : Unknown
Verified November 2006 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : November 16, 2006
Last Update Posted : November 16, 2006
Information provided by:
Hospices Civils de Lyon

Brief Summary:
To assess the efficacy of systemic corticosteroids alone as first-line treatment of polyarteritis nodosa and microscopic polyangiitis 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
Polyarteritis Nodosa Microscopic Polyangiitis 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)

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Study Type : Interventional  (Clinical Trial)
Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients
Study Start Date : July 1996

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)

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women with newly diagnosed polyarteritis nodosa or microscopic polyangiitis;
  • 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.
  • Both genders eligible;
  • age ≥ 15 years.

Exclusion Criteria:

  • age < 15 years, previously treated systemic vasculitis;
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400075

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Camillo Ribi
Geneva, Switzerland
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Jean-François Cordier, MD Hospices Civils de Lyon

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00400075     History of Changes
Other Study ID Numbers: 95.067/2
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: November 16, 2006
Last Verified: November 2006
Keywords provided by Hospices Civils de Lyon:
Additional relevant MeSH terms:
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Microscopic Polyangiitis
Systemic Vasculitis
Polyarteritis Nodosa
Vascular Diseases
Cardiovascular Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Vascular
Skin Diseases
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, Antineoplastic