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Study of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease

NCT00624351 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2011-09-12

No results posted yet for this study

Summary

The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in patients with SLE.

Conditions

Interventions

BIOLOGICAL

Epratuzumab

Epratuzumab at a concentration of 10 mg/mL prepared in 17.5 ml vials for slow intravenous infusion using only Phosphate buffered Saline (PBS) as a vehicle/buffer for the infusion procedure.

OTHER

Placebo

Phosphate-buffered Saline (PBS) infusion.

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
2008-01-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States
  • Belgium
  • Brazil
  • Hong Kong
  • Hungary
  • India
  • Lithuania
  • Poland
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00624351 on ClinicalTrials.gov