Open-label Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease

July 3, 2012 updated by: UCB Pharma

A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007

The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
      • Leuven, Belgium
  • Brazil
      • Porto Alegre, Brazil
      • Sao Paulo, Brazil
    • GO
      • Goiania, GO, Brazil
  • Hong Kong
      • Shatin, Hong Kong
  • Hungary
      • Debrecen, Hungary
      • Zalaegerszeg, Hungary
  • India
      • Bangalore, India
      • Hyderabad, India
      • Manipal, India
      • Nagpur, India
    • Tamilnadu
      • Madurai, Tamilnadu, India
  • Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Vilnius, Lithuania
  • Poland
      • Elblag, Poland
      • Konskie, Poland
      • Lublin, Poland
      • Poznan, Poland
      • Torun, Poland
  • Spain
      • Barcelona, Spain
      • Santander, Spain
  • Ukraine
      • Donetsk, Ukraine
      • Ivano-Frankivsk, Ukraine
      • Kiev, Ukraine
      • Lviv, Ukraine
  • United Kingdom
      • Birmingham, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • San Leandro, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Farmington, Connecticut, United States
    • Florida
      • Tampa, Florida, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
      • Charlotte, North Carolina, United States
      • Durham, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Virginia
      • Arlington, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
  • Patients must have maintained eligibility requirements throughout their participation in SL0007
  • Written informed consent signed prior to initiation of any study-specific assessments at visit 1

Exclusion Criteria:

  • Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
  • Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
  • Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
  • Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
  • Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EMAB
1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
Biological: Epratuzumab
Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only PBS as a vehicle/buffer for the infusion procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
Time Frame: 12 Week treatment cycles
12 Week treatment cycles

Secondary Outcome Measures

Outcome Measure
Time Frame
The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status
Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion
Every 4 weeks through week 48, then every 12 weeks through completion
The combined response index including an additional criteria involving the SF-36 response
Time Frame: Every 12 weeks
Every 12 weeks
BILAG score assessment
Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion
Every 4 weeks through week 48, then every 12 weeks through completion
SLEDAI scores assessment
Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion
Every 4 weeks through week 48, then every 12 weeks through completion
Patient and physician VAS
Time Frame: Every 4 weeks through week 48, then every 12 weeks through completion
Every 4 weeks through week 48, then every 12 weeks through completion
Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline
Time Frame: Every 12 weeks
Every 12 weeks
SF-36 PCS, MCS
Time Frame: Every 12 weeks
Every 12 weeks
EQ-5D results
Time Frame: Every 12 weeks
Every 12 weeks
Proportion of patients meeting treatment failure
Time Frame: Every 12 weeks
Every 12 weeks
Total daily steroid dose
Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks
Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to flare for patients who entered the study without flare as defined by the BILAG
Time Frame: over the entire course of the trial
over the entire course of the trial
SLEDAI responder
Time Frame: Every 4 weeks for the first 48 weeks and then every 12 weeks
Every 4 weeks for the first 48 weeks and then every 12 weeks
Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.
Time Frame: over the entire course of the trial
over the entire course of the trial
Immunogenicity as measured by human anti-human antibodies
Time Frame: at each dosing visit and 4 weeks post first dose of each treatment cycle
at each dosing visit and 4 weeks post first dose of each treatment cycle
Assessment of changes in baseline in levels of circulating B and T cells
Time Frame: The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle
The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

July 12, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SL0008
  • EudraCT Number: 2007-002589-37

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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