IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Completed · Early Phase 1
Conditions studied: Cutaneous Lupus Erythematosus
In brief
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.
Key facts
- Study ID
- NCT01841619
- Run by
- University of California, Irvine
- People needed
- 16
- Starts
- 2013-03-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2015-08-10
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Institute for Clinical and Translational Science (ICTS) — Irvine, California, United States
- Unversity of California, Irvine Healthcare, Dermatology, Gottschalk Medical Plaza — Irvine, California, United States
Full record on ClinicalTrials.gov
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