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

This study has been completed.
Roche Pharma AG
Information provided by:
Cambridge University Hospitals NHS Foundation Trust Identifier:
First received: February 16, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted

February 16, 2006
February 16, 2006
March 2002
Not Provided
  • 1. Clinical remission at 6 or 12 months
  • 2. Absence of a severe life threatening adverse event
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
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.

Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Systemic Lupus Erythematosus
  • ANCA Associated Vasculitis
Drug: Rituximab
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2005
Not Provided

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 -
18 Years to 70 Years
Contact information is only displayed when the study is recruiting subjects
United Kingdom
Pilot study of Rituximab
Not Provided
Not Provided
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