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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00293072
• Other study ID #: Pilot study of Rituximab
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2006
• Last updated: February 16, 2006
• Start date: March 2002
• Est. completion date: May 2005

Study information

• Verified date: October 2005
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ANCA Associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Vasculitis

Intervention

Drug:
• Rituximab

Locations

Country	Name	City	State
United Kingdom	Addenbrooke's Hospital	Cambridge	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	Roche Pharma AG

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Clinical remission at 6 or 12 months
Primary	2. Absence of a severe life threatening adverse event