Clinical Trial: IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus
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 erythematosis (CLE) patients.
Detailed Summary:
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 cutaneous lupus erythematosis (CLE) patients. This project has relevant clinical implications due to the severe side effects of and lack of response to current therapies.
From the review of literature, it can be postulated that:
- the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks;
- clinical improvement should last several weeks after the last infusion; and
- remission may be prolonged by maintenance IVIg therapy.
Although this is only a non-controlled study, the investigator expects that IVIg will improve CLE, including those resistant to standard treatments. It is anticipated that treatment with IVIg will facilitate healing of extensive cutaneous lesions and achieve rapid remission. Maintenance therapy with repeated monthly pulses of IVIg is expected to keep the disease in remission during the treatment-free follow up observational period. The results will provide the basis a multicenter randomized controlled study to identify which CLE subsets will benefit the most and which protocol will provide the optimal clinical outcome.
Sponsor: University of California, Irvine
Current Primary Outcome:
- Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS) [ Time Frame: Initial, 1st Visit - 9th Visit ]
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 percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
- Skindex 29 [ Time Frame: Initial, 1st Visit - 9th Visit ]The subjects also evaluated their skin-specific quality of life with the Skindex-29 − the questionnaire consisting of 29 items used to calculate three subscales: symptoms (pain, itch, burning, sensitivity), emotions (depression, anxiety, embarrassment, anger) and functioning (sleep, relationships with others). All assessments were repeated at all study visits. 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 percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
Original Primary Outcome: Physician's Subjective Assessment of Severity (PSAS) [ Time Frame: PSAS will be assessed at every visit for the duration of the study, an expected total of 9 months. ]
Current Secondary Outcome:
- Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI) [ Time Frame: Initial, 1st Visit - 9th Visit ]
At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.
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 percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
- Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS) [ Time Frame: Initial, 1st Visit - 9th Visit ]
At clinic visits, the investigator will categorize the change in disease activity in each patient as improved, unchanged, or worse since the last visit. Estimated change in disease activity will be based on the investigator's subjective assessment of the patient's skin disease.
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 percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
- Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS) [ Time Frame: Initial, 1st Visit - 9th Visit ]
Disease activity will be measured using the CLASI activity score that describes the damage 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 percentage indicates worsening of CLE. Visits occur on a month-to-month basis.
All patients were measured identically in all visits.
Original Secondary Outcome: Physician's Subjective Assessment of Improvement (PSAI) [ Time Frame: PSAI will be assessed at every visit for the duration of the study, an expected total of 9 months. ]
Information By: University of California, Irvine
Dates:
Date Received: April 21, 2013
Date Started: March 2013
Date Completion:
Last Updated: July 14, 2015
Last Verified: March 2015
