Status:
COMPLETED
IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Grifols Therapeutics LLC
Conditions:
Cutaneous Lupus Erythematosus
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief 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 erythematosi...
Detailed Description
The ultimate goal of this pilot project is to generate proof-of-concept data showing that treatment with intravenous immunoglobulin (IVIg) can replace current systemic immunosuppressive therapy in cut...
Eligibility Criteria
Inclusion
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- Be at least 18 years of age at time of informed consent.
- Have had a diagnosis of CLE
- Currently has active CLE (any subtype) established by standard clinical and histo- and immunopathologic criteria
- Falls into one of the two following cohorts:
- Cohort 1 - Has received a standard systemic therapy without a therapeutic response for a minimum of one month
- Cohort 2 - Has not received any systemic treatment
Exclusion
- Subject is not over 18 years of age.
- Subject cannot understand or follow directions.
- Subject is a female of child-bearing potential and unwilling to use a form of highly effective birth control.
- Subject is pregnant, planning to get pregnant, or breast feeding.
- Subject has a known history of immunoglobulin A (IgA) deficiency.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01841619
Start Date
March 1 2013
End Date
November 1 2014
Last Update
August 10 2015
Active Locations (2)
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1
The Institute for Clinical and Translational Science (ICTS)
Irvine, California, United States, 92697
2
Unversity of California, Irvine Healthcare, Dermatology, Gottschalk Medical Plaza
Irvine, California, United States, 92697