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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04044690
Registration number
NCT04044690
Ethics application status
Date submitted
1/08/2019
Date registered
5/08/2019
Date last updated
25/10/2023
Titles & IDs
Public title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
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Scientific title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
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Secondary ID [1]
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2018-003171-35
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Secondary ID [2]
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IgPro20_3007
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Universal Trial Number (UTN)
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Trial acronym
RECLAIIM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dermatomyositis
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - human immunoglobulin G
Treatment: Drugs - Placebo
Experimental: IgPro20 - human immunoglobulin G administered subcutaneously
Placebo Comparator: Placebo - human albumin solution administered subcutaneously
Treatment: Drugs: human immunoglobulin G
human immunoglobulin G administered subcutaneously
Treatment: Drugs: Placebo
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Responder Rate
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Assessment method [1]
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A responder is defined as a subject with a total improvement score (TIS) = 20 points at Week 25 and at least 1 of the previous scheduled visits (Week 17 or Week 21), who completes 24 weeks of randomized investigational medicinal product (IMP) treatment without the use of rescue corticosteroid treatment. The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). Thresholds for minimal, moderate, and major improvement were = 20, = 40, and = 60 points on the TIS.
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Timepoint [1]
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Weeks 17, 21, and 25
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Secondary outcome [1]
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Mean Total Improvement Score (TIS)
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Assessment method [1]
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The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were = 20, = 40, and = 60 points on the TIS.
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Timepoint [1]
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Up to Week 25
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Secondary outcome [2]
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Mean difference (IgPro20 minus placebo) in TIS
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Assessment method [2]
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The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were = 20, = 40, and = 60 points on the TIS.
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Timepoint [2]
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Up to week 25
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Secondary outcome [3]
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Mean changes from Baseline in Manual Muscle Testing (MMT-8)
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Assessment method [3]
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MMT-8 is a set of 8 designated muscles which will be tested bilaterally (potential score 0 to 150): 7 biaxial muscles with potential score 0 to140 and 1 axial (neck flexors) with potential score 0 to10. Improvement is documented with an increase in score.
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Timepoint [3]
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Up to week 25
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Secondary outcome [4]
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Mean change difference (IgPro20 minus placebo) in MMT-8
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Assessment method [4]
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MMT-8 is a set of 8 designated muscles which will be tested bilaterally (potential score 0 to 150): 7 biaxial muscles with potential score 0 to140 and 1 axial (neck flexors) with potential score 0 to10. Improvement is documented with an increase in score.
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Timepoint [4]
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Up to week 25
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Secondary outcome [5]
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Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score
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Assessment method [5]
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The CDASI in its modified version (v2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score.
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Timepoint [5]
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Up to week 25
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Secondary outcome [6]
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Mean change difference (IgPro20 minus placebo) in CDASI
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Assessment method [6]
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The CDASI in its modified version (v2) is a validated tool of skin disease activity (3 items) and damage (3 items) assessment. Scores range from 0-100 for activity and from 0-32 for damage. Improvement is documented with a decrease in score.
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Timepoint [6]
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Up to week 25
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Secondary outcome [7]
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Mean TIS
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Assessment method [7]
0
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The TIS is a sum response criterion which incorporates 6 weighted IMACS core set measures (CSMs). A total improvement score (range 0 to 100), determined by summing scores for each CSM, was based on improvement in and relative weight of each CSM. Thresholds for minimal, moderate, and major improvement were = 20, = 40, and = 60 points on the TIS.
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Timepoint [7]
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Week 5 up to Week 53
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Secondary outcome [8]
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Percentage of subjects achieving TIS = 20, = 40, and = 60 points
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Assessment method [8]
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Timepoint [8]
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Week 5 up to Week 53
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Secondary outcome [9]
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Time to first achieving TIS = 20, = 40, and = 60 points on the TIS
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Assessment method [9]
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Timepoint [9]
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Week 5 up to Week 53
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Secondary outcome [10]
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Percentage of subjects achieving TIS = 20 points at the end of study period 2
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Assessment method [10]
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0
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Timepoint [10]
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Up to week 53
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Secondary outcome [11]
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Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI
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Assessment method [11]
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0
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Timepoint [11]
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Between Week 5 and Week 25
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Secondary outcome [12]
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Mean changes in individual CSMs (except muscle enzymes) and CDASI
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Assessment method [12]
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Timepoint [12]
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From week 29 to week 53
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Secondary outcome [13]
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Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice
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Assessment method [13]
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The DOW consists of meeting 1 of the following criteria on 2 consecutive visits at least 2 weeks apart:
Physician Global Activity Assessment Visual Analog Scale (VAS) worsening = 2 cm* and Manual Muscle Test (MMT)-8 worsening = absolute 10%, or
Extramuscular Global Assessment worsening = 2 cm on the Myositis Disease Activity Assessment Tool (MDAAT) VAS, or
Any 3 of 6 CSM worsening by = absolute 20%
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Timepoint [13]
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Baseline up to Week 53
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Secondary outcome [14]
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Percentage of subjects meeting DOW at least once, twice, or > twice
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Assessment method [14]
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Timepoint [14]
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Baseline up to Week 53
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Secondary outcome [15]
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Time to meeting DOW for the first time
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Assessment method [15]
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Timepoint [15]
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Baseline up to Week 53
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Secondary outcome [16]
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Number of subjects meeting DOW and receiving rescue steroid treatment
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Assessment method [16]
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Timepoint [16]
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Baseline up to Week 53
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Secondary outcome [17]
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Percentage of subjects meeting DOW and receiving rescue steroid treatment
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Assessment method [17]
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Timepoint [17]
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Baseline up to Week 53
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Secondary outcome [18]
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Percentage of subjects receiving rescue steroid treatment
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Assessment method [18]
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Timepoint [18]
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Baseline up to Week 25
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Secondary outcome [19]
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Percentage of subjects whose rescue steroid treatment is tapered
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Assessment method [19]
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Timepoint [19]
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Baseline up to Week 25
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Secondary outcome [20]
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Number of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EuroQoL 5-Dimension Questionnaire (EQ-5D-5L)
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Assessment method [20]
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The subject will select which best describes his own health state at the study visit in the following dimensions: Mobility, Self-care, Usual Activities. The subject will also select a point on a scale drawn like a thermometer to indicate how good or bad the health state is, with best state as "100" and worst state as "0."
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Timepoint [20]
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Baseline up to Week 53
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Secondary outcome [21]
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Percentage of subjects having at least 1 level, 2 levels, and more than 2 levels of improvement from Baseline in mobility, self-care, and usual activities domains of EQ-5D-5L
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Assessment method [21]
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Timepoint [21]
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Baseline up to Week 53
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Secondary outcome [22]
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Number of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25
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Assessment method [22]
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Timepoint [22]
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From Week 25 up to week 53
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Secondary outcome [23]
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Percentage of subjects having no reduction in levels, at least 1 level, 2 levels, and more than 2 levels of improvement in mobility, self-care, and usual activities domains of EQ-5D-5L from Week 25
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Assessment method [23]
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Timepoint [23]
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From Week 25 up to week 53
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Secondary outcome [24]
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Percentage of subjects with Treatment Emergent Adverse Events (TEAEs)
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Assessment method [24]
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Timepoint [24]
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Up to week 197
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Secondary outcome [25]
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Percentage of subjects with related TEAEs
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Assessment method [25]
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0
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Timepoint [25]
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Up to week 197
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Secondary outcome [26]
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Percentage of subjects with serious TEAEs
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Assessment method [26]
0
0
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Timepoint [26]
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Up to week 197
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Secondary outcome [27]
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Rate of TEAEs per days with infusion
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Assessment method [27]
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0
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Timepoint [27]
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Up to week 197
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Secondary outcome [28]
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Rate of TEAEs per days with infusion, by severity
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Assessment method [28]
0
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Timepoint [28]
0
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Up to week 197
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Secondary outcome [29]
0
0
Rate of related TEAEs per days with infusion
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Assessment method [29]
0
0
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Timepoint [29]
0
0
Up to week 197
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Secondary outcome [30]
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Rate of serious TEAEs per days with infusion
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Assessment method [30]
0
0
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Timepoint [30]
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Up to week 197
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Secondary outcome [31]
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Number of subjects who are able to reduce the oral corticosteroid dose by = 25%
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Assessment method [31]
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Timepoint [31]
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Up to Week 25
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Secondary outcome [32]
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Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%
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Assessment method [32]
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Timepoint [32]
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Up to Week 25
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Secondary outcome [33]
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The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by = 25%
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Assessment method [33]
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Timepoint [33]
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Up to Week 25
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Secondary outcome [34]
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Number of subjects who start oral corticosteroid dose taper
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Assessment method [34]
0
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Timepoint [34]
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Baseline up to Week 53
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Secondary outcome [35]
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Percentage of subjects who start oral corticosteroid dose taper
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Assessment method [35]
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0
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Timepoint [35]
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Baseline up to Week 53
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Secondary outcome [36]
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Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%
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Assessment method [36]
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0
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Timepoint [36]
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Baseline up to Week 25
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Secondary outcome [37]
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Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%
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Assessment method [37]
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0
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Timepoint [37]
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Baseline up to Week 25
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Secondary outcome [38]
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Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75%
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Assessment method [38]
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0
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Timepoint [38]
0
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Baseline up to Week 53
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Secondary outcome [39]
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Time to first intake of rescue corticosteroid treatment
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Assessment method [39]
0
0
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Timepoint [39]
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Baseline up to Week 25
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Eligibility
Key inclusion criteria
- Male or female subjects = 18 years of age
- Diagnosis of at least probable idiopathic inflammatory myopathies (IIM) per European
League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification
Criteria which includes confirmation of dermatomyositis (DM) rash/manifestation,
disease activity defined by presence of DM rash / manifestation or an objective
disease activity measure
- Disease severity defined by Physician global activity visual analog scale (VAS) with a
minimum value of 2.0 cm on a 10 cm scale and MMT-8 = 142 or CDASI total activity score
= 14.
- Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Cancer-associated myositis
- Evidence of active malignant disease or malignancies diagnosed within the previous 5
years
- Physician Global Damage score = 3, or clinically relevant improvement between
Screening Visit and Baseline
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/11/2027
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Actual
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Sample size
Target
126
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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State/province [1]
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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United States of America
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Texas
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Country [11]
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Argentina
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Buenos Aires
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Liège
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France
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Dijon
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France
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Lille Cedex
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France
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Marseille
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France
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Nice
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Country [19]
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France
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Paris
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France
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Strasbourg
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Göttingen
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Germany
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Hannover
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Germany
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Köln
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Germany
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Münster
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Germany
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Tuebingen
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Germany
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Ulm
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Hungary
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0
Debrecen
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0
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Italy
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0
Brescia
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0
0
Italy
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Catania
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Italy
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State/province [32]
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0
Firenze
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Italy
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Pisa
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Japan
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Aichi
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Japan
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Fukui
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Japan
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Gunma
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Tokyo
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Japan
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Wakayama
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Japan
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Yamaguchi
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Mexico
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Distrito Federal
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Mexico
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Jalisco
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Mexico
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San Luis Potosí
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Poland
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Lublin
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Russian Federation
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Yaroslavl
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Spain
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A Coruña
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Spain
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Barcelona
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Switzerland
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Bern
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Switzerland
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Saint Gallen
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Ukraine
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Cherkasy
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Ukraine
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Kharkiv
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Ukraine
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Khmelnytskyi
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0
0
Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Zaporizhia
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United Kingdom
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State/province [61]
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0
Doncaster
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20
(subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM). The primary
objective of this study is to assess the efficacy of IgPro20 subcutaneous (SC) doses in
comparison to placebo in adult subjects with DM, as measured by responder status based on
Total Improvement Score (TIS) assessments.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04044690
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Study Director
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CSL Behring
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Contact person for public queries
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Trial Registration Coordinator
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610-878-4000
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04044690
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