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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Systemic Lupus Erythematosus, ANCA Associated Vasculitis

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Trial Information

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


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 -

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

1. Clinical remission at 6 or 12 months

Principal Investigator

Ken Smith

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cambridge Institute for Medical Research, Addenbrooke's Hospital

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

Pilot study of Rituximab

NCT ID:

NCT00293072

Start Date:

March 2002

Completion Date:

May 2005

Related Keywords:

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

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