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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00293072
Date of registration: 16/02/2006
Prospective Registration: No
Primary sponsor: Cambridge University Hospitals NHS Foundation Trust
Public title: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Scientific title: Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy
Date of first enrolment: March 2002
Target sample size: 20
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00293072
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United Kingdom
Contacts
Name:     David Jayne
Address: 
Telephone:
Email:
Affiliation:  Lupus and Vasculitis Service, Addenbrooke's Hospital
Name:     Ken Smith
Address: 
Telephone:
Email:
Affiliation:  Cambridge Institute for Medical Research, Addenbrooke's Hospital
Key inclusion & exclusion criteria

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 -



Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Systemic Lupus Erythematosus
ANCA Associated Vasculitis
Intervention(s)
Drug: Rituximab
Primary Outcome(s)
1. Clinical remission at 6 or 12 months
2. Absence of a severe life threatening adverse event
Secondary Outcome(s)
Secondary ID(s)
Pilot study of Rituximab
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Roche Pharma AG
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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