ANCA + Vasculitides Relapsing Either Under Corticosteroid Clinical Trial
Official title:
Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener’s Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial
| Verified date | April 2003 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.
| Status | Terminated |
| Enrollment | 40 |
| Est. completion date | July 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Wegener’s granulomatosis, Microscopic polyangiitis and Churg-Strauss syndrome (satisfying ACR or chapel Hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment - Age > 18 years old - Written informed consent Exclusion Criteria: - Systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s) - Systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago - Polyarteritis nodosa - Absence of poor prognosis criteria (according to FFS) - Nephritis ± renal impairment - Cancer or malignancy - Psychiatric disease, lack of compliance - Age under 18 years old - Lack of written informed consent - Other vasculitides (post viral infection and skin localisation) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Hopital Cochin | Paris | |
| France | Hôpital COCHIN | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the remission rate after 9 months of therapy with intravenous immunoglobulins, | |||
| Primary | in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener’s granulomatosis and Churg-Strauss syndrome) | |||
| Primary | during 6 months, after relapse | |||
| Secondary | Safety, i.e. side-effects classified according to the WHO guidelines |