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

This study has been completed.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00293072
First received: February 16, 2006
Last updated: NA
Last verified: October 2005
History: No changes posted
  Purpose

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 Intervention Phase
Systemic Lupus Erythematosus
ANCA Associated Vasculitis
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy

Resource links provided by NLM:


Further study details as provided by Cambridge University Hospitals NHS Foundation Trust:

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

Estimated Enrollment: 20
Study Start Date: March 2002
Estimated Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293072

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Roche Pharma AG
Investigators
Principal Investigator: Ken Smith Cambridge Institute for Medical Research, Addenbrooke's Hospital
Principal Investigator: David Jayne Lupus and Vasculitis Service, Addenbrooke's Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293072     History of Changes
Other Study ID Numbers: Pilot study of Rituximab
Study First Received: February 16, 2006
Last Updated: February 16, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Cambridge University Hospitals NHS Foundation Trust:
Rituximab, ANCA, vasculitis, lupus,

Additional relevant MeSH terms:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Lupus Erythematosus, Systemic
Vasculitis
Autoimmune Diseases
Cardiovascular Diseases
Connective Tissue Diseases
Immune System Diseases
Systemic Vasculitis
Vascular Diseases
Rituximab
Antineoplastic Agents
Antirheumatic Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014