Clinical trial NCT00382837: Study of Epratuzumab in Systemic Lupus Erythematosus
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus,
Antibody,
B-Cell immunotherapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
Secondary outcomes:
measure: To continue to assess the efficacy and tolerability of epratuzumab;
measure: To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
measure: To continue to assess epratuzumab on Health-related quality of life in lupus patients;
measure: To continue to assess disease status as reported by the patient and physician.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Upland
country: United States
state: California
city: Farmington
country: United States
state: Connecticut
city: Washington
country: United States
state: District of Columbia
city: Aventura
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Durham
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Gallipolis
country: United States
state: Ohio
city: Tulsa
country: United States
state: Oklahoma
city: Charleston
country: United States
state: South Carolina
city: Dallas
country: United States
state: Texas
city: Arlington
country: United States
state: Virginia
city: Edmonds
country: United States
state: Washington
city: Brussels
country: Belgium
city: Liege
country: Belgium
city: Rio De Janeiro
country: Brazil
state: RJ
city: Goiania
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Winnipeg
country: Canada
state: Manitoba
city: Hradec Kralove
country: Czech Republic
city: Olomouc
country: Czech Republic
city: Praha 2
country: Czech Republic
city: Paris
country: France
city: Toulouse Cedex 9
country: France
city: Erlangen
country: Germany
city: Heidelberg
country: Germany
city: Mannheim
country: Germany
city: München
country: Germany
city: Debrecen
country: Hungary
city: Pecs
country: Hungary
city: Ancona
country: Italy
city: Brescia
country: Italy
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Piestany
country: Slovakia
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Leeds
country: United Kingdom
state: West Yorkshire
city: Birmingham
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Sheffield
country: United Kingdom
Study officials:
affiliation: UCB Pharma
name: Anna Barry
role: STUDY_DIRECTOR
References: