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IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01841619
Recruitment Status : Completed
First Posted : April 26, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
Sponsor:
Collaborator:
Grifols Therapeutics LLC
Information provided by (Responsible Party):
Sergei Grando, University of California, Irvine

Tracking Information
First Submitted Date  ICMJE April 21, 2013
First Posted Date  ICMJE April 26, 2013
Results First Submitted Date  ICMJE December 8, 2014
Results First Posted Date  ICMJE August 10, 2015
Last Update Posted Date August 10, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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 Measures  ICMJE
 (submitted: April 23, 2013)
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. ]
Subjects will be categorized as having mild, moderate, or severe disease by the investigator, based on his or her subjective assessment of disease activity.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
  • 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 Measures  ICMJE
 (submitted: April 23, 2013)
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. ]
At clinic visits, the investigator will categorize disease activity in each patient as improved, unchanged, or worse since the last visit. These assignments will be based on the investigator's subjective assessment of the patient's skin disease.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 23, 2013)
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) [ Time Frame: CLASI will be assessed at every visit for the duration of the study, an expected total of 9 months. ]
Disease activity will be measured using the CLASI activity score. This score ranges from 0-70, with higher scores indicating more severe skin disease (see CLASI form below). This clinical assessment tool enables standardized assessments of response to therapy. The CLASI has two scores, as mandated by the FDA. The first describes the activity of the disease while the second describes the damage done by the disease. The CLASI has already been shown to have good content validity, addressing the most relevant aspects of CLE, as determined by an expert panel of dermato-rheumatologists (1). It also has good inter-rater and intra-rater reliability when used by either dermatologists or rheumatologists (2-5). Several clinical studies have demonstrated responsiveness in all subsets of CLE, including individual lesions, localized and generalized (6-8).
 
Descriptive Information
Brief Title  ICMJE IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus
Official Title  ICMJE 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 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 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:

  1. the beneficial effects of IVIg for patients with CLE should be prompt, with marked improvement within a few weeks;
  2. clinical improvement should last several weeks after the last infusion; and
  3. 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cutaneous Lupus Erythematosus
Intervention  ICMJE 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.
Other Name: Intravenous Immunoglobin
Study Arms  ICMJE Active Comparator: IVIg as a monotherapy
IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.
Intervention: Drug: IVIg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2013)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01841619
Other Study ID Numbers  ICMJE 2013-9351
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sergei Grando, University of California, Irvine
Study Sponsor  ICMJE University of California, Irvine
Collaborators  ICMJE Grifols Therapeutics LLC
Investigators  ICMJE
Principal Investigator: Sergei Grando, MD PhD D.Sc. University of California, Irvine
PRS Account University of California, Irvine
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP