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RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infliximab
Rituximab
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wegener's Granulomatosis focused on measuring Systemic ANCA+ vascularizes, Relapse, Corticosteroids, Immunosuppressant, Infliximab/rituximab, Patients with relapsing or refractory forms of ANCA, associated vasculitides Microscopic polyangiitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Rituximab

Infliximab

Outcomes

Primary Outcome Measures

Partial or complete remission of the vasculitides

Secondary Outcome Measures

To study the safety and adverse effects of both regimens
Microscopic polyangiitis
Wegener's granulomatosis
Churg-Strauss syndrome

Full Information

First Posted
March 24, 2006
Last Updated
November 16, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00307593
Brief Title
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Official Title
Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Rituximab
Arm Title
2
Arm Type
Active Comparator
Arm Description
Infliximab
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Infliximab
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Rituximab
Primary Outcome Measure Information:
Title
Partial or complete remission of the vasculitides
Time Frame
one year
Secondary Outcome Measure Information:
Title
To study the safety and adverse effects of both regimens
Time Frame
one year
Title
Microscopic polyangiitis
Time Frame
one year
Title
Wegener's granulomatosis
Time Frame
one year
Title
Churg-Strauss syndrome
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc GUILLEVIN, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cochin
City
Paris
ZIP/Postal Code
75679
Country
France

12. IPD Sharing Statement

Learn more about this trial

RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

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