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

Phase 2

Completed

• Conditions: Systemic Lupus Erythematosus; ANCA Associated Vasculitis

• Registration Number: NCT00293072
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Study Completion: 2005-05
• Status Verified: 2005-10
• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Last Update Submitted: 2006-02-16
• Study First Posted: 2006-02-17
• Last Update Posted: 2006-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
1. Clinical remission at 6 or 12 months
2. Absence of a severe life threatening adverse event

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom