Clinical trial NCT00383214: Study of Epratuzumab in Systemic Lupus Erythematosus (SLE)
Official title: A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus,
antibody,
B-cell immunotherapy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with SLE.


Eligibility criteria: Inclusion Criteria:

* +ANA at screening
* BILAG Index B Level Activity in at least 2 body systems/organs
* Has SLE by ACR revised criteria (meets,\<4 criteria)

Exclusion Criteria:

* Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
* Allergy to human antibodies or Murine.

Primary outcomes:
measure: Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
Secondary outcomes:
measure: Proportion of patients with complete response or partial response;
measure: Individual BILAG assessments;
measure: Physician and patient assessment scores;
measure: Time-to treatment failure;
measure: Successful steroid reduction by weeks 20 and 24;
measure: Maintenance of steroid reduction at 24 and 48 weeks;
measure: Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
measure: Assess epratuzumab on Health-related quality of life
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: Colorado Springs
country: United States
state: Colorado
city: Denver
country: United States
state: Colorado
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: Plainview
country: United States
state: New York
city: Rochester
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: Philadelphia
country: United States
state: Pennsylvania
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: Sorocaba
country: Brazil
city: Winnipeg
country: Canada
state: Manitoba
city: St John's
country: Canada
state: Newfoundland and Labrador
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: Ancona
country: Italy
city: Brescia
country: Italy
city: Amsterdam
country: Netherlands
city: Groningen
country: Netherlands
city: Leiden
country: Netherlands
city: Barcelona
country: Spain
city: La Laguna
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
city: United Kingdom
country: United Kingdom
Study officials:
affiliation: UCB Pharma
name: Anna Barry
role: STUDY_DIRECTOR
References:
citation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3(3):CD007478. doi: 10.1002/14651858.CD007478.pub2.