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CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis 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:
ClinicalTrials.gov Identifier:
NCT00400075
First Posted: November 16, 2006
Last Update Posted: November 16, 2006
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.
Information provided by:
Hospices Civils de Lyon
  Purpose
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 Intervention Phase
Polyarteritis Nodosa Microscopic Polyangiitis 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 PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients

Resource links provided by NLM:


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: 124
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

Information from the National Library of Medicine

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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 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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00400075


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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00400075     History of Changes
Other Study ID Numbers: 95.067/2
First Submitted: November 14, 2006
First Posted: November 16, 2006
Last Update Posted: November 16, 2006
Last Verified: November 2006

Keywords provided by Hospices Civils de Lyon:
Polyarteritis
Vasculitis
Therapy
Cyclophosphamide
Azathioprine

Additional relevant MeSH terms:
Systemic Vasculitis
Microscopic Polyangiitis
Polyarteritis Nodosa
Vasculitis
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
Arteritis
Skin Diseases, Vascular
Skin 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