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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cutaneous Lupus Erythematosus
Intervention Drug: IVIg
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  93.8%
>=65 years
1
   6.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
15
  93.8%
Male
1
   6.3%
1.Primary Outcome
Title Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Activity Score (CLASI - TAS)
Hide Description

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.

Time Frame Initial, 1st Visit - 9th Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description:

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent of Baseline
Initial 100  (0)
1st Visit 94  (30)
2nd Visit 84  (29)
3rd Visit 94  (52)
4th Visit 86  (19)
5th Visit 85  (14)
6th Visit 72  (37)
7th Visit 68  (33)
8th Visit 81  (17)
9th Visit 71  (13)
2.Primary Outcome
Title Skindex 29
Hide Description 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.
Time Frame Initial, 1st Visit - 9th Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description:

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent of Baseline
Initial 100  (0)
1st Visit 97  (3)
2nd Visit 94  (9)
3rd Visit 92  (12)
4th Visit 90  (15)
5th Visit 81  (21)
6th Visit 79  (23)
7th Visit 83  (30)
8th Visit 99  (11)
9th Visit 82  (21)
3.Secondary Outcome
Title Mean Percent Change in Physician's Subjective Assessment of Improvement (PSAI)
Hide Description

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.

Time Frame Initial, 1st Visit - 9th Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description:

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent of Baseline
Intial 100  (0)
1st Visit 100  (0)
2nd Visit 100  (0)
3rd Visit 136  (79)
4th Visit 104  (48)
5th Visit 105  (52)
6th Visit 117  (37)
7th Visit 133  (47)
8th Visit 150  (77)
9th Visit 100  (29)
4.Secondary Outcome
Title Mean Percent Change in Physician's Subjective Assessment of Severity (PSAS)
Hide Description

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.

Time Frame Initial, 1st Visit - 9th Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description:

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent of Baseline
Initial 100  (0)
1st Visit 100  (0)
2nd Visit 98  (8)
3rd Visit 100  (10)
4th Visit 97  (18)
5th Visit 92  (19)
6th Visit 92  (18)
7th Visit 92  (20)
8th Visit 90  (18)
9th Visit 90  (17)
5.Secondary Outcome
Title Cutaneous Lupus Erythematosus Disease Area and Severity Index - Total Damage Score (CLASI - TDS)
Hide Description

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.

Time Frame Initial, 1st Visit - 9th Visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description:

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Percent of Baseline
Initial 100  (0)
1st Visit 100  (0)
2nd Visit 100  (0)
3rd Visit 100  (0)
4th Visit 100  (0)
5th Visit 100  (0)
6th Visit 100  (0)
7th Visit 100  (0)
8th Visit 100  (0)
9th Visit 100  (0)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVIg as a Monotherapy
Hide Arm/Group Description

IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.

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.

All-Cause Mortality
IVIg as a Monotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IVIg as a Monotherapy
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVIg as a Monotherapy
Affected / at Risk (%) # Events
Total   9/16 (56.25%)    
Blood and lymphatic system disorders   
Anemia *  2/16 (12.50%) 
Neutropenia *  1/16 (6.25%) 
Gastrointestinal disorders   
GI Upset *  1/16 (6.25%) 
Nausea/Vomting *  2/16 (12.50%) 
General disorders   
Fever *  2/16 (12.50%) 
Immune system disorders   
Oral Lupus Flare *  1/16 (6.25%) 
Lupus Flare *  2/16 (12.50%) 
Infections and infestations   
Diabetic Foot Ulcer *  1/16 (6.25%) 
Musculoskeletal and connective tissue disorders   
Back Spasms *  1/16 (6.25%) 
Nervous system disorders   
Headache *  3/16 (18.75%)  5
Skin and subcutaneous tissue disorders   
Herpes – Associated Erythema Multiforme *  1/16 (6.25%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sergei A. Grando
Organization: UC Irvine Dermatology Research Center
Phone: 949 824 7103
EMail: sgrando@uci.edu
Layout table for additonal information
Responsible Party: Sergei Grando, University of California, Irvine
ClinicalTrials.gov Identifier: NCT01841619     History of Changes
Other Study ID Numbers: 2013-9351
First Submitted: April 21, 2013
First Posted: April 26, 2013
Results First Submitted: December 8, 2014
Results First Posted: August 10, 2015
Last Update Posted: August 10, 2015