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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00307593
Other study ID # P020931
Secondary ID AOM02098
Status Completed
Phase N/A
First received March 24, 2006
Last updated November 16, 2007
Start date May 2004
Est. completion date June 2007

Study information

Verified date March 2007
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Infliximab
Infliximab
Rituximab
Rituximab

Locations

Country Name City State
France Hôpital Cochin Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Partial or complete remission of the vasculitides one year
Secondary To study the safety and adverse effects of both regimens one year
Secondary Microscopic polyangiitis one year
Secondary Wegener's granulomatosis one year
Secondary Churg-Strauss syndrome one year
See also
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