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CompletedNCT00307593Updated Nov 19, 2007

RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

An interventional study of Infliximab and Rituximab in Wegener's Granulomatosis, Churg-Strauss Syndrome and Microscopic Polyangiitis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-19.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Wegener's Granulomatosis
  • Churg-Strauss Syndrome
  • Microscopic Polyangiitis

Keywords

  • Systemic ANCA+ vascularizes
  • Relapse
  • Corticosteroids
  • Immunosuppressant
  • Infliximab/rituximab
  • Patients with relapsing or refractory forms of ANCA
  • associated vasculitides Microscopic polyangiitis
03

In context

Granulomatosis with Polyangiitis

107 studies on the registry are indexed under Granulomatosis with Polyangiitis; 19 are open to participants now.

This study's enrollment of 20 is below the median of 68 across 68 interventional studies indexed under Granulomatosis with Polyangiitis.

Browse Granulomatosis with Polyangiitis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Newly diagnosed patient
  • Patient that had never received an immunosuppressant before to treat his/her vasculitis
  • Malignancy
  • Pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    1

    Rituximab

    Drug: Rituximab

  • Active comparator
    2

    Infliximab

    Drug: Infliximab

Interventions

06

What researchers measure

Primary outcomes

  1. Partial or complete remission of the vasculitides

    Time frame: one year

Secondary outcomes

  1. To study the safety and adverse effects of both regimens

    Time frame: one year

  2. Microscopic polyangiitis

    Time frame: one year

  3. Wegener's granulomatosis

    Time frame: one year

  4. Churg-Strauss syndrome

    Time frame: one year

07

Study locations

1 site
  • Hôpital Cochin
    Paris, 75679, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00307593
First posted
Mar 28, 2006
Start date
May 2004
Completion
Jun 2007
Last update
Nov 19, 2007

Study contacts

Loïc GUILLEVIN, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Infliximab · Rituximab

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