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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: |
NCT00111306 |
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Date of registration:
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19/05/2005 |
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Prospective Registration:
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Yes |
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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, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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510 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00111306 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, 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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Hungary
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Netherlands
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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 |
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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:
- Has SLE by ACR revised criteria (meets <4 criteria);
- Has SLE with at least one elevated lupus antibody;
- Has new onset of severe lupus disease flare in at least one body or organ system,
excluding renal or neurologic
Exclusion Criteria:
- Active severe CNS or Renal disease defined by BILAG as Level A
- Allergy to murine or human antibodies
- Antiphospholid antibodies AND a history of thrombocytopenic events
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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Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks.
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Secondary Outcome(s)
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Proportion of patients with complete response or partial response;
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Successful steroid reduction by weeks 20 and 24;
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Maintenance of steroid reduction at 24 and 48 weeks;
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Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
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Assess epratuzumab on Health-related quality of life.
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Physician and patient assessment scores;
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Individual BILAG assessments;
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Time-to treatment failure;
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Secondary ID(s)
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SL0003 (IMMU-103-03)
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EudraCT #: 2005-000705-59
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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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