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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus; ANCA Associated Vasculitis
• Intervention / Treatment: Drug: Rituximab

• Study Type: Interventional
• Enrollment: 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
      • Addenbrooke's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2002
• Study Completion: May 1, 2005

Study Registration Dates

• First Submitted: February 16, 2006
• First Submitted That Met QC Criteria: February 16, 2006
• First Posted (Estimate): February 17, 2006

Study Record Updates

• Last Update Posted (Estimate): February 17, 2006
• Last Update Submitted That Met QC Criteria: February 16, 2006
• Last Verified: October 1, 2005

More Information

Terms related to this study

• Keywords: Rituximab, ANCA, vasculitis, lupus,
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Systemic Vasculitis; Lupus Erythematosus, Systemic; Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Physiological Effects of Drugs; Antirheumatic Agents; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Rituximab
• Other Study ID Numbers: Pilot study of Rituximab