NCT00307671

Brief Summary

The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 12, 2011

Status Verified

March 1, 2007

Enrollment Period

6 years

First QC Date

March 27, 2006

Last Update Submit

September 9, 2011

Conditions

VasculitisWegener's GranulomatosisMicroscopic PolyangiitisChurg-Strauss SyndromePolyarteritis Nodosa

Keywords

Systemic necrotizing vasculitidescorticosteroids; azathioprine; mycophenolate mofetil;cyclophosphamideElderly patientsRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Number of side effects (morbidity)

    at 3 years

Secondary Outcomes (5)

  • Survival

    at 3 years

  • Efficacy of treatment (remission rate)

    during the 3 years

  • Relapse rate

    at 3 years

  • Cumulative dose exposure to OCS and AZA

    at 3 years

  • Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values

    at 3 years

Study Arms (2)

A

OTHER

conventional treatment

Drug: prednisone, methylprednisolone,cyclophosphamidesDrug: Mycophenolate mofetil,methotrexate

B

EXPERIMENTAL

reduction dose

Drug: Cyclophosphamide, Azathioprine,prednisone,methylprednisoloneDrug: Mycophenolate mofetil,methotrexate

Interventions

prednisone, methylprednisolone,cyclophosphamidesDRUG

treatment conventional

A
Cyclophosphamide, Azathioprine,prednisone,methylprednisoloneDRUG

reduction dose

B
Mycophenolate mofetil,methotrexateDRUG

in the treatment conventional and in the reduction dose

AB

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Newly diagnosed WG, MPA, PAN without HBV infection, or CSS
  • Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol.
  • within or after the 65th of anniversary
  • Age ≥ 65 years

You may not qualify if:

  • Any cytotoxic drug within previous year
  • Co-existence of another systemic autoimmune disease, e.g., SLE, RA
  • Virus-associated vasculitides
  • HIV positivity
  • Malignancy (usually excluded unless approved by the trial coordinator)
  • Age \< 65 years
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75679, France

Location

Related Publications (1)

  • Pagnoux C, Quemeneur T, Ninet J, Diot E, Kyndt X, de Wazieres B, Reny JL, Puechal X, le Berruyer PY, Lidove O, Vanhille P, Godmer P, Fain O, Blockmans D, Bienvenu B, Rollot F, Ait el Ghaz-Poignant S, Mahr A, Cohen P, Mouthon L, Perrodeau E, Ravaud P, Guillevin L; French Vasculitis Study Group. Treatment of systemic necrotizing vasculitides in patients aged sixty-five years or older: results of a multicenter, open-label, randomized controlled trial of corticosteroid and cyclophosphamide-based induction therapy. Arthritis Rheumatol. 2015 Apr;67(4):1117-27. doi: 10.1002/art.39011.

    PMID: 25693055DERIVED

MeSH Terms

Conditions

VasculitisGranulomatosis with PolyangiitisMicroscopic PolyangiitisChurg-Strauss SyndromePolyarteritis Nodosa

Interventions

PrednisoneMethylprednisoloneCyclophosphamideAzathioprineMycophenolic AcidMethotrexate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesGranulomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesArteritis

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPrednisolonePregnadienetriolsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsThionucleosidesSulfur CompoundsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesCaproatesAcids, AcyclicCarboxylic AcidsFatty AcidsLipidsAminopterinPterinsPteridines

Study Officials

  • Loïc Guillevin, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2006

First Posted

March 28, 2006

Study Start

July 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 12, 2011

Record last verified: 2007-03

Locations

FR(1)