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Study of Epratuzumab Versus Placebo in Subjects With Moderate to Severe General Systemic Lupus Erythematosus

NCT01262365 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 793

Last updated 2018-09-28

Study results available
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Summary

The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with Systemic Lupus Erythematosus (SLE)

Conditions

Interventions

DRUG

Epratuzumab

600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles

DRUG

Epratuzumab

1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles

DRUG

Placebo

Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • UCb Clinical Trial Call Center · +1 877 822 9493 (UCB)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Bulgaria
  • Czechia
  • Estonia
  • France
  • Germany
  • India
  • Israel
  • Italy
  • Lithuania
  • Mexico
  • Puerto Rico
  • Romania
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01262365 on ClinicalTrials.gov