RATTRAP: Infliximab Versus Rituximab in Systemic Necrotiz... | NCT00307593

Studies
RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

NCT00307593

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Nov 19, 2007Estimated

Enrollment

20Actual

Phase

Not Applicable

Conditions

Wegener's Granulomatosis
Churg-Strauss Syndrome
Microscopic Polyangiitis

Interventions

Infliximab
Rituximab

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
AOM02098

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

Mar 24, 2006

First Submission Date that Met QC Criteria

Mar 24, 2006

First Posted Date

Mar 28, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2007

Last Update Posted Date

Nov 19, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Rituximab	Drug: Rituximab
2	Active Comparator	Infliximab	Drug: Infliximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Infliximab	Drug	Infliximab	2
Rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Partial or complete remission of the vasculitides		one year

Secondary Outcomes

Measure	Description	Time Frame
To study the safety and adverse effects of both regimens		one year
Microscopic polyangiitis		one year
Wegener's granulomatosis

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Loïc GUILLEVIN, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Cochin		Paris		75679	France

Condition Browse Module

MeSH Terms

ID	Term
D014890	Granulomatosis with Polyangiitis
D015267	Churg-Strauss Syndrome
D055953	Microscopic Polyangiitis
D012008	Recurrence

Ancestor Terms

ID	Term
D017563	Lung Diseases, Interstitial
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D056648	Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069285	Infliximab
D000069283	Rituximab

Ancestor Terms

ID	Term
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins

Browse Leaves

Not provided

Browse Branches

Not provided