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Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis

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ClinicalTrials.gov Identifier: NCT00293072
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : February 17, 2006
Roche Pharma AG
Information provided by:
Cambridge University Hospitals NHS Foundation Trust

February 16, 2006
February 17, 2006
February 17, 2006
March 2002
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  • 1. Clinical remission at 6 or 12 months
  • 2. Absence of a severe life threatening adverse event
Same as current
No Changes Posted
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Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to treat these conditions toxic therapies such as cyclophosphamide and steroids are often required. These standard treatments are associated with significant side effects. Furthermore a proportion of patient do not respond to these conventional therapies. Newer safer therapies are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one part of the human immune system that helps prevent infections. Abnormal activity of the immune system is responsible for autoimmune disease although the exact mechanisms in lupus and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this context. It has recently been used to treat some autoimmune conditions with positive results. In this pilot study we wish to assess the effectiveness and safety of rituximab in patients with lupus and vascultis that are resistant to conventional therpies.
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Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Systemic Lupus Erythematosus
  • ANCA Associated Vasculitis
Drug: Rituximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2005
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Inclusion Criteria:

  1. Diagnosis of SLE or ANCA associated vasculitis
  2. Active disease refractory to 6 months conventional therapy with cyclophosphamide, prednisolone and at least one other immunosupressive agent ( or a lesser period if this therapy cannot be tolerated)
  3. Age 18-70

Exclusion Criteria:

  1. HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
  2. Pregnancy, inadequate contraception or lactation
  3. Malignancy
  4. Current enrolment in pother clinicla trials -
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Pilot study of Rituximab
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Cambridge University Hospitals NHS Foundation Trust
Roche Pharma AG
Principal Investigator: Ken Smith Cambridge Institute for Medical Research, Addenbrooke's Hospital
Principal Investigator: David Jayne Lupus and Vasculitis Service, Addenbrooke's Hospital
Cambridge University Hospitals NHS Foundation Trust
October 2005

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