RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00307593
First received: March 24, 2006
Last updated: November 16, 2007
Last verified: March 2007
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

Resource links provided by NLM:


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
Active Comparator: 1
Rituximab
Drug: Rituximab
Rituximab
Other Name: Rituximab
Active Comparator: 2
Infliximab
Drug: Infliximab
Infliximab
Other Name: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Churg-Strauss Syndrome
Vasculitis
Systemic Vasculitis
Wegener Granulomatosis
Microscopic Polyangiitis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Autoimmune Diseases
Immune System Diseases
Cerebral Small Vessel Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Rituximab
Antibodies, Monoclonal
Infliximab
Immunosuppressive Agents
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014