NCT00307593

Brief Summary

The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2004

Typical duration for not_applicable

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

May 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 19, 2007

Status Verified

March 1, 2007

First QC Date

March 24, 2006

Last Update Submit

November 16, 2007

Conditions

Wegener's GranulomatosisChurg-Strauss SyndromeMicroscopic Polyangiitis

Keywords

Systemic ANCA+ vascularizesRelapseCorticosteroidsImmunosuppressantInfliximab/rituximabPatients with relapsing or refractory forms of ANCAassociated vasculitides Microscopic polyangiitis

Outcome Measures

Primary Outcomes (1)

  • Partial or complete remission of the vasculitides

    one year

Secondary Outcomes (4)

  • To study the safety and adverse effects of both regimens

    one year

  • Microscopic polyangiitis

    one year

  • Wegener's granulomatosis

    one year

  • Churg-Strauss syndrome

    one year

Study Arms (2)

1

ACTIVE COMPARATOR

Rituximab

Drug: Rituximab

2

ACTIVE COMPARATOR

Infliximab

Drug: Infliximab

Interventions

InfliximabDRUG

Infliximab

2
RituximabDRUG

Rituximab

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemic ANCA positive (+) vasculitides
  • Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
  • Age \>18 years old
  • Written informed consent

You may not qualify if:

  • Newly diagnosed patient
  • Patient that had never received an immunosuppressant before to treat his/her vasculitis
  • Malignancy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin

Paris, 75679, France

Location

MeSH Terms

Conditions

Granulomatosis with PolyangiitisChurg-Strauss SyndromeMicroscopic PolyangiitisRecurrence

Interventions

InfliximabRituximab

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisSystemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesGranulomaLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesCerebral Small Vessel DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAntibodies, Monoclonal, Murine-Derived

Study Officials

  • Loïc GUILLEVIN, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

May 1, 2004

Study Completion

June 1, 2007

Last Updated

November 19, 2007

Record last verified: 2007-03

Locations

FR(1)