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RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

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ClinicalTrials.gov Identifier: NCT00307593
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : November 19, 2007
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Wegener's Granulomatosis Churg-Strauss Syndrome Microscopic Polyangiitis Drug: Infliximab Drug: Rituximab Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
Study Start Date : May 2004
Actual Study Completion Date : June 2007


Arm Intervention/treatment
Active Comparator: 1
Rituximab
Drug: Rituximab
Rituximab

Active Comparator: 2
Infliximab
Drug: Infliximab
Infliximab




Primary Outcome Measures :
  1. Partial or complete remission of the vasculitides [ Time Frame: one year ]

Secondary Outcome Measures :
  1. To study the safety and adverse effects of both regimens [ Time Frame: one year ]
  2. Microscopic polyangiitis [ Time Frame: one year ]
  3. Wegener's granulomatosis [ Time Frame: one year ]
  4. Churg-Strauss syndrome [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307593


Locations
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France
Hôpital Cochin
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Loïc GUILLEVIN, MD, PhD Assistance Publique - Hôpitaux de Paris

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ClinicalTrials.gov Identifier: NCT00307593     History of Changes
Other Study ID Numbers: P020931
AOM02098
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: November 19, 2007
Last Verified: March 2007
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:
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Granulomatosis with Polyangiitis
Microscopic Polyangiitis
Vasculitis
Systemic Vasculitis
Churg-Strauss Syndrome
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
Infliximab
Immunosuppressive Agents
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Dermatologic Agents