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

NCT00293072 | Completed Phase 2

• 1 other identifier: Pilot study of Rituximab
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Lupus Erythematosus; ANCA Associated Vasculitis

Keywords

Rituximab, ANCA, vasculitis, lupus,

Outcome Measures

Primary Outcomes (2)

• 1. Clinical remission at 6 or 12 months

• 2. Absence of a severe life threatening adverse event

Interventions

Rituximab DRUG

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ken Smith

  Cambridge Institute for Medical Research, Addenbrooke's Hospital

  PRINCIPAL INVESTIGATOR

• David Jayne

  Lupus and Vasculitis Service, Addenbrooke's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 16, 2006
• First Posted: February 17, 2006
• Study Start: March 1, 2002
• Study Completion: May 1, 2005
• Last Updated: February 17, 2006

Record last verified: 2005-10

Locations

GB (1)