Clinical trial NCT00400075: CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors
Official title: CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polyarteritis Nodosa
Microscopic Polyangiitis
Keywords: Polyarteritis
Vasculitis
Therapy
Cyclophosphamide
Azathioprine
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2006-11-16
Enrollment: 124
Sex: ALL
Minimum age (years): 15
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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:
measure: Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Camillo Ribi
Study officials:
affiliation: Hospices Civils de Lyon
name: Jean-François Cordier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.