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NCT01841619 · ClinicalTrials.gov registry record · Early Phase 1
IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
A Early Phase 1 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 16
- Enrollment target
NCT01841619: Completed Early Phase 1 study, sponsored by University of California, Irvine.
NCT01841619 is a Early Phase 1 study that has completed, run by University of California, Irvine. The registered enrollment target is 16 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01841619, a Early Phase 1 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
Disease activity will be measured using the CLASI activity score that describes the activity of the disease. This score ranges from 0-70, with higher scores indicating more severe skin disease. This clinical assessment tool enables standardized assessments of response to therapy. Results expressed relative to the mean initial value of all patients, taken as 100%. Each proceeding visit will be relative to the initial visit. A decrease in percentage represents improvement while an increase in per
Interventions
- DRUG IVIg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-03 |
| Est. Completion | 2014-11 |
| Phase | Early Phase 1 |
What the finished NCT01841619 record still lists
NCT01841619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which IVIg is the first listed.
NCT01841619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01841619 about?
NCT01841619 is a clinical study titled "IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus". 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.
What is the current status of trial NCT01841619?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 16 participants. The study started on 2013-03. Estimated completion is 2014-11.
What interventions are being tested in trial NCT01841619?
The interventions under investigation include: IVIg (DRUG).
Who is sponsoring clinical trial NCT01841619?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01841619's enrollment target sits among peer trials
16 1370th of 2000 higher than 598 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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