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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

1996-07-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Polyarteritis Nodosa Microscopic Polyangiitis

Keywords

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Polyarteritis Vasculitis Therapy Cyclophosphamide Azathioprine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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azathioprine

Intervention Type DRUG

cyclophosphamide

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jean-François Cordier, MD

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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Camillo Ribi

Geneva, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED

PMID: 25153486 (View on PubMed)

Other Identifiers

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95.067/2

Identifier Type: -

Identifier Source: org_study_id