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Trial record 36 of 907 for:    Lupus

IVIg Efficacy Study to Treat Cutaneous Lupus Erythematosus

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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

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.

Condition or disease Intervention/treatment Phase
Cutaneous Lupus Erythematosus Drug: IVIg Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Proof-of-Concept Study of IVIg Efficacy in Patients With Cutaneous Lupus Erythematosus
Study Start Date : March 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841619


Locations
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United States, California
The Institute for Clinical and Translational Science (ICTS)
Irvine, California, United States, 92697
Unversity of California, Irvine Healthcare, Dermatology, Gottschalk Medical Plaza
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Grifols Therapeutics LLC
Investigators
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Principal Investigator: Sergei Grando, MD PhD D.Sc. University of California, Irvine

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Responsible Party: Sergei Grando, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01841619     History of Changes
Other Study ID Numbers: 2013-9351
First Posted: April 26, 2013    Key Record Dates
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015
Last Verified: March 2015
Keywords provided by Sergei Grando, University of California, Irvine:
skin, lupus, intravenous immunoglobulin, ivig
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Lupus Erythematosus, Cutaneous
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases
Immunoglobulins, Intravenous
gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs