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RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE March 24, 2006
First Posted Date  ICMJE March 28, 2006
Last Update Posted Date November 19, 2007
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2007)		 Partial or complete remission of the vasculitides [ Time Frame: one year ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2006)
  • Partial or complete remission of the vasculitides
  • Microscopic Polyangiitis,
  • Wegener's granulomatosis
  • SCHURG-STRAUSS syndrome
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2006)		 To study the safety and adverse effects of both regimens.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RATTRAP: Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides
Official Title  ICMJE Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Wegener's Granulomatosis
  • Churg-Strauss Syndrome
  • Microscopic Polyangiitis
Intervention  ICMJE
  • Drug: Infliximab
    Infliximab
  • Drug: Rituximab
    Rituximab
Study Arms  ICMJE
  • Active Comparator: 1
    Rituximab
    Intervention: Drug: Rituximab
  • Active Comparator: 2
    Infliximab
    Intervention: Drug: Infliximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2006)		 20
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00307593
Other Study ID Numbers  ICMJE P020931
AOM02098
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Loïc GUILLEVIN, MD, PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP