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

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. 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus ANCA Associated Vasculitis Drug: Rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
Study Start Date : March 2002
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Vasculitis
Drug Information available for: Rituximab

Primary Outcome Measures :
  1. 1. Clinical remission at 6 or 12 months
  2. 2. Absence of a severe life threatening adverse event

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 -

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 identifier (NCT number): NCT00293072

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United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Roche Pharma AG
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Principal Investigator: Ken Smith Cambridge Institute for Medical Research, Addenbrooke's Hospital
Principal Investigator: David Jayne Lupus and Vasculitis Service, Addenbrooke's Hospital
Layout table for additonal information Identifier: NCT00293072    
Other Study ID Numbers: Pilot study of Rituximab
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: February 17, 2006
Last Verified: October 2005
Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Rituximab, ANCA, vasculitis, lupus,
Additional relevant MeSH terms:
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Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Vascular Diseases
Cardiovascular Diseases
Systemic Vasculitis
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents