Churg-Strauss Syndrome, Microscopic Polyangiitis, Wegener's Granulomatosis
Conditions
Keywords
Systemic ANCA+ vascularizes, Relapse, Corticosteroids, Immunosuppressant, Infliximab/rituximab, Patients with relapsing or refractory forms of ANCA, associated vasculitides Microscopic polyangiitis
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.
Detailed description
The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).
Interventions
DRUGInfliximab
Infliximab
DRUGRituximab
Rituximab
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Systemic ANCA positive (+) vasculitides * Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies * Age \>18 years old * Written informed consent
Exclusion criteria
* Newly diagnosed patient * Patient that had never received an immunosuppressant before to treat his/her vasculitis * Malignancy * Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Partial or complete remission of the vasculitides | one year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed