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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT04044690
Date of registration: 01/08/2019
Prospective Registration: Yes
Primary sponsor: CSL Behring
Public title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) RECLAIIM
Scientific title: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
Date of first enrolment: October 21, 2019
Target sample size: 126
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT04044690
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Germany Italy Japan Russian Federation Switzerland Ukraine United States
Contacts
Name:     Trial Registration Coordinator
Address: 
Telephone: 610-878-4000
Email: clinicaltrials@cslbehring.com
Affiliation: 
Name:     Study Director
Address: 
Telephone:
Email:
Affiliation:  CSL Behring
Key inclusion & exclusion criteria

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

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Dermatomyositis
Intervention(s)
Drug: human immunoglobulin G
Drug: Placebo
Primary Outcome(s)
Responder Rate [Time Frame: Weeks 17, 21, and 25]
Secondary Outcome(s)
Mean change difference (IgPro20 minus placebo) in CDASI [Time Frame: Up to week 25]
Mean change difference (IgPro20 minus placebo) in MMT-8 [Time Frame: Up to week 25]
Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score [Time Frame: Up to week 25]
Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI [Time Frame: Between Week 5 and Week 25]
Mean changes from Baseline in Manual Muscle Testing (MMT-8) [Time Frame: Up to week 25]
Mean changes in individual CSMs (except muscle enzymes) and CDASI [Time Frame: From week 29 to week 53]
Mean difference (IgPro20 minus placebo) in TIS [Time Frame: Up to week 25]
Mean TIS [Time Frame: Week 5 up to Week 53]
Mean Total Improvement Score (TIS) [Time Frame: Up to Week 25]
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) [Time Frame: Baseline up to Week 53]
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 [Time Frame: From Week 25 up to week 53]
Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice [Time Frame: Baseline up to Week 53]
Number of subjects meeting DOW and receiving rescue steroid treatment [Time Frame: Baseline up to Week 53]
Number of subjects who are able to reduce the oral corticosteroid dose by = 25% [Time Frame: Up to Week 25]
Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75% [Time Frame: Baseline up to Week 25]
Number of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75% [Time Frame: Baseline up to Week 53]
Number of subjects who start oral corticosteroid dose taper [Time Frame: Baseline up to Week 53]
Percentage of subjects achieving TIS = 20 points at the end of study period 2 [Time Frame: Up to week 53]
Percentage of subjects achieving TIS = 20, = 40, and = 60 points [Time Frame: Week 5 up to Week 53]
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 [Time Frame: Baseline up to Week 53]
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 [Time Frame: From Week 25 up to week 53]
Percentage of subjects meeting DOW and receiving rescue steroid treatment [Time Frame: Baseline up to Week 53]
Percentage of subjects meeting DOW at least once, twice, or > twice [Time Frame: Baseline up to Week 53]
Percentage of subjects receiving rescue steroid treatment [Time Frame: Baseline up to Week 25]
Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25% [Time Frame: Up to Week 25]
Percentage of subjects who are able to reduce the oral corticosteroid dose by = 25%, = 50%, = 75% [Time Frame: Baseline up to Week 25]
Percentage of subjects who start oral corticosteroid dose taper [Time Frame: Baseline up to Week 53]
Percentage of subjects whose rescue steroid treatment is tapered [Time Frame: Baseline up to Week 25]
Percentage of subjects with related TEAEs [Time Frame: Up to week 197]
Percentage of subjects with serious TEAEs [Time Frame: Up to week 197]
Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [Time Frame: Up to week 197]
Rate of related TEAEs per days with infusion [Time Frame: Up to week 197]
Rate of serious TEAEs per days with infusion [Time Frame: Up to week 197]
Rate of TEAEs per days with infusion [Time Frame: Up to week 197]
Rate of TEAEs per days with infusion, by severity [Time Frame: Up to week 197]
The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by = 25% [Time Frame: Up to Week 25]
Time to first achieving TIS = 20, = 40, and = 60 points on the TIS [Time Frame: Week 5 up to Week 53]
Time to first intake of rescue corticosteroid treatment [Time Frame: Baseline up to Week 25]
Time to meeting DOW for the first time [Time Frame: Baseline up to Week 53]
Secondary ID(s)
2018-003171-35
IgPro20_3007
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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