RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome

Treatments: Drug: Rituximab; Drug: Infliximab

Study type: Interventional

Funder types: Other

Identifiers

NCT00307593

P020931

AOM02098

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

1

Active Comparator group

Description:

Rituximab

Treatment:

Drug: Rituximab

2

Active Comparator group

Description:

Infliximab

Treatment:

Drug: Infliximab