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
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
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
NCT ID
NCT00307593
First Posted
March 24, 2006
Last Updated
November 16, 2007
Sponsor
Assistance Publique - Hôpitaux de Paris
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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