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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00293072 |
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Date of registration:
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16/02/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
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Scientific title:
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Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis Resistant to Conventional Therapy |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00293072 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Ken Smith |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cambridge Institute for Medical Research, Addenbrooke's Hospital |
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Name:
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David Jayne |
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Address:
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Telephone:
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Email:
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Affiliation:
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Lupus and Vasculitis Service, Addenbrooke's Hospital |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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ANCA Associated Vasculitis
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Rituximab
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Primary Outcome(s)
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1. Clinical remission at 6 or 12 months
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2. Absence of a severe life threatening adverse event
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Secondary ID(s)
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Pilot study of Rituximab
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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