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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293072

Enrollment

Registered

2006-02-17

Start date

2002-03-31

Completion date

2005-05-31

Last updated

2006-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA Associated Vasculitis, Systemic Lupus Erythematosus

Keywords

Rituximab, ANCA, vasculitis, lupus,

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.

Interventions

DRUGRituximab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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 -

Design outcomes

Primary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026