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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 because the information has not been verified recently.
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:
NCT00400075
First received: November 14, 2006
Last updated: November 15, 2006
Last verified: November 2006
History of Changes
  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: 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:

MedlinePlus related topics: 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: 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

Ages Eligible for Study:   15 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00400075     History of Changes
Other Study ID Numbers: 95.067/2
Study First Received: November 14, 2006
Last Updated: November 15, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Polyarteritis Nodosa
Systemic Vasculitis
Microscopic Polyangiitis
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Azathioprine
Cyclophosphamide
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 23, 2013