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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00382837 |
Date of registration:
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29/09/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Study of Epratuzumab in Systemic Lupus Erythematosus
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Scientific title:
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A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems |
Date of first enrolment:
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January 2007 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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http://clinicaltrials.gov/show/NCT00382837 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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Brazil
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Canada
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Czech Republic
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France
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Germany
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Hungary
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Italy
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Netherlands
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Slovakia
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Anna Barry |
Address:
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Telephone:
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Email:
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Affiliation:
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UCB Pharma |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must have completed SL0003 Alleviate A through 48 weeks
Exclusion Criteria:
- Development of toxicity to Epratuzumab
- Significant protocol deviations from SL0003 Study.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Drug: Epratuzumab
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Primary Outcome(s)
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The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
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Secondary Outcome(s)
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To continue to assess epratuzumab on Health-related quality of life in lupus patients;
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To continue to assess disease status as reported by the patient and physician.
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To continue to assess the efficacy and tolerability of epratuzumab;
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To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
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Secondary ID(s)
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EudraCT# 2006-003865-15
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SL0005
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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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