Clinical Trials Logo
  1. Home
  2. Microscopic Polyangiitis
  3. NCT00400075

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

Microscopic Polyangiitis Clinical Trial

Official title:
CHUSPAN PAN BP Treatment of Polyarteritis Nodosa and Microscopic Polyangiitis Without Poor-Prognosis Factors a Prospective Randomized Study in 125 Patients

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00400075
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Active, not recruiting
Phase Phase 4
Start date July 1996
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT01729624 - PRO Development for ANCA Associated Vasculitis N/A
Terminated NCT02474888 - Pharmacokinetic Study of Rituximab Induction Regimen in ANCA-associated Vasculitis
Active, not recruiting NCT02198248 - Low-dose Glucocorticoid Vasculitis Induction Study Phase 4
Completed NCT02190916 - Vasculitis Illness Perception (VIP) Study N/A
Recruiting NCT01241305 - One-Time DNA Study for Vasculitis
Completed NCT00748644 - Efficacy Study of Two Treatments in the Remission of Vasculitis Phase 3
Recruiting NCT02967068 - VCRC Tissue Repository
Completed NCT01731561 - Comparison Study of Two Rituximab Regimens in the Remission of ANCA Associated Vasculitis Phase 3
Not yet recruiting NCT06350110 - Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE) Phase 1/Phase 2
Not yet recruiting NCT02126098 - Observation Study of Clinical Manifestation and Outcome in Chinese Patients With Pulmonary Vasculitis N/A
Completed NCT02190942 - VCRC Patient Contact Registry Patient-Reported Data Validation Study
Terminated NCT01586858 - Rituximab for ANCA-associated Vasculitis (RAVE) Long-Term Follow-Up Study N/A
Completed NCT00307593 - RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides N/A
Completed NCT02190929 - Educational Needs of Patients With Systemic Vasculitis N/A
Terminated NCT01408836 - Plasma Exchange for Renal Vasculitis Phase 2/Phase 3
Terminated NCT05376319 - PR3-AAV Resilient Remission or PRRR Phase 2
Completed NCT02476292 - Impact of Vasculitis on Employment and Income N/A
Completed NCT02169219 - Pilot Study of Short-Course Glucocorticoids and Rituximab for Treatment of ANCA-Associated Vasculitis Phase 4
Completed NCT01613599 - An Observational Study of The Safety of MabThera/Rituxan (Rituximab) in Participants With Granulomatosis With Polyangiitis (Wegener's) or Microscopic Polyangiitis
Active, not recruiting NCT05716334 - Biosimilars of Rituximab in ANCA-associated Vasculitis Compared to the Originator