Intravenous Immunoglobulin After Relapse in Vasculitis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00307658
• Date of registration: 27/03/2006
• Prospective Registration: No
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Intravenous Immunoglobulin After Relapse in Vasculitis
• Scientific 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
• Date of first enrolment: March 2001
• Target sample size: 40
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00307658
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France

Contacts

• Name: Loïc GUILLEVIN, MD,PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

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)



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

and Immunosuppressant Therapies or After One Year

Post Treatment.

ANCA + Vasculitides Relapsing Either Under Corticosteroid

Intervention(s)

Drug: Intravenous immunoglobulins (human immunoglobulins G)

Primary Outcome(s)

in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener’s granulomatosis and Churg-Strauss syndrome)

the remission rate after 9 months of therapy with intravenous immunoglobulins,

during 6 months, after relapse

Secondary Outcome(s)

Safety, i.e. side-effects classified according to the WHO guidelines

Secondary ID(s)

P991006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors