RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00307593

Purpose

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.

Condition	Intervention
Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis	Drug: Infliximab Drug: Rituximab

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis Wegener's Granulomatosis

Drug Information available for: Infliximab Rituximab

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Partial or complete remission of the vasculitides [ Time Frame: one year ]

Secondary Outcome Measures:

To study the safety and adverse effects of both regimens [ Time Frame: one year ]
Microscopic polyangiitis [ Time Frame: one year ]
Wegener's granulomatosis [ Time Frame: one year ]
Churg-Strauss syndrome [ Time Frame: one year ]

Enrollment:	20
Study Start Date:	May 2004
Study Completion Date:	June 2007

Arms	Assigned Interventions
1: Active Comparator Rituximab	Drug: Rituximab Rituximab
2: Active Comparator Infliximab	Drug: Infliximab Infliximab

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307593

Locations

France
Hôpital Cochin
Paris, France, 75679

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Loïc GUILLEVIN, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Study ID Numbers:	P020931, AOM02098
Study First Received:	March 24, 2006
Last Updated:	November 16, 2007
ClinicalTrials.gov Identifier:	NCT00307593 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Systemic ANCA+ vascularizes
Relapse
Corticosteroids
Immunosuppressant

Infliximab/rituximab
Patients with relapsing or refractory forms of ANCA
associated vasculitides Microscopic polyangiitis

Study placed in the following topic categories:

Anti-Inflammatory Agents
Lung Diseases, Interstitial
Vasculitis
Immunologic Factors
Rituximab
Infliximab
Churg-Strauss Syndrome
Vascular Diseases
Granuloma
Immunosuppressive Agents

Microscopic Polyangiitis
Lymphatic Diseases
Wegener Granulomatosis
Respiratory Tract Diseases
Urologic Diseases
Lung Diseases
Wegener's Granulomatosis
Kidney Diseases
Antirheumatic Agents
Lymphoproliferative Disorders

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Churg-Strauss Syndrome
Infliximab
Antineoplastic Agents
Physiological Effects of Drugs
Pathologic Processes
Respiratory Tract Diseases
Urologic Diseases
Syndrome
Therapeutic Uses
Cardiovascular Diseases
Kidney Diseases
Dermatologic Agents

Lung Diseases, Interstitial
Disease
Vasculitis
Rituximab
Gastrointestinal Agents
Vascular Diseases
Granuloma
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Wegener Granulomatosis
Lung Diseases
Lymphoproliferative Disorders
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2009