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IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

NCT01841619 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2015-08-10

Study results available
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Summary

The purpose of this research study is to show that non-steroidal treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cutaneous lupus erythematosis (CLE) patients.

Conditions

  • Cutaneous Lupus Erythematosus

Interventions

DRUG

IVIg

All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in \<25% subjects, the subjects will be re-treated by the standard protocol.

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    collaborator INDUSTRY

  • University of California, Irvine

    lead OTHER

Principal Investigators

  • Sergei Grando, MD PhD D.Sc. · University of California, Irvine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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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 NCT01841619 on ClinicalTrials.gov