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Trial record 1 of 1 for:    NCT00382837
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Study of Epratuzumab in Systemic Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00382837
Recruitment Status : Withdrawn
First Posted : October 2, 2006
Last Update Posted : May 21, 2014
Sponsor:
Information provided by:
UCB Pharma

Study Description
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Brief Summary:
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Epratuzumab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.

Secondary Outcome Measures :
  1. To continue to assess the efficacy and tolerability of epratuzumab;
  2. To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
  3. To continue to assess epratuzumab on Health-related quality of life in lupus patients;
  4. To continue to assess disease status as reported by the patient and physician.

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have completed SL0003 Alleviate A through 48 weeks

Exclusion Criteria:

  • Development of toxicity to Epratuzumab
  • Significant protocol deviations from SL0003 Study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00382837


Locations
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Sponsors and Collaborators
UCB Pharma
Investigators
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Study Director: Anna Barry UCB Pharma
More Information
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ClinicalTrials.gov Identifier: NCT00382837    
Other Study ID Numbers: SL0005
EudraCT# 2006-003865-15
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: May 21, 2014
Last Verified: March 2007
Keywords provided by UCB Pharma:
Lupus,
Antibody,
B-Cell immunotherapy
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
 Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents