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

Sponsor

Cambridge University Hospitals NHS Foundation Trust (Other)

Overall Status

Completed

CT.gov ID

NCT00293072

Collaborator

Roche Pharma AG (Industry)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Mar 1, 2002

Study Completion Date :

May 1, 2005

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of SLE or ANCA associated vasculitis
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)
Age 18-70

Exclusion Criteria:

HbeAg or HCV Ab positive or known HIV positivity ( HIV testing not necessary for this study)
Pregnancy, inadequate contraception or lactation
Malignancy
Current enrolment in pother clinicla trials -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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