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OpenTrials
Completed

NCT Number: NCT00307593

RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

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.

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Key information

Conditions

Wegener's Granulomatosis Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Autoimmune Diseases Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Churg-Strauss Syndrome Disease Attributes Granuloma Granulomatosis with Polyangiitis Hemic and Lymphatic Diseases Immune System Diseases Lung Diseases Lung Diseases, Interstitial Lymphatic Diseases Lymphoproliferative Disorders Microscopic Polyangiitis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Respiratory Tract Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Systemic Vasculitis Vascular Diseases Vasculitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin

Paris, 75679, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infliximab

Drug

Infliximab

Rituximab

Drug

Rituximab

Primary outcomes

  1. Partial or complete remission of the vasculitides

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies

Important dates

Study start
2004
Study completion
2007
First posted
Mar 28, 2006
Registry last updated
Nov 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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