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A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM) (RECLAIIM)

Primary Purpose

Dermatomyositis

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
human immunoglobulin G
Placebo
Sponsored by
CSL Behring
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatomyositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 8401117 - Arizona Arthritis & Rheumatology ResearchRecruiting
  • 8401199 - Neuromuscular Research CenterRecruiting
  • 8401129 - UCLA - Rheumatology Los AngelesRecruiting
  • 8401473 - RecioMed Clinical Research Network, Inc.Recruiting
  • 8401160 - Center For RheumatologyRecruiting
  • 8401132 - Omega Research MaitlandRecruiting
  • 8401107 - Morsani Center for Advanced Health Care (CAHC)Recruiting
  • 8401152 - The University of Kansas Medical CenterRecruiting
  • 8401476 - DS Research
  • 8401487 - Ohio State UniversityRecruiting
  • 8401486 - Oregon Health and Science UniversityRecruiting
  • 8401210 - University of PennsylvaniaRecruiting
  • 8401151 - Biomedical Science TowerRecruiting
  • 8401474 - West Tennessee Research Institute, LLCRecruiting
  • 8401115 - The University of Texas Medical School at HoustonRecruiting
  • 0320083 - Hospital Italiano de Buenos Aires
  • 0560050 - Ghent Universit Hospital (UZ Gent)Recruiting
  • 0560048 - Universitair Ziekenhuis (UZ) LeuvenRecruiting
  • 0560056 - Universitair Ziekenhuis LeuvenRecruiting
  • 0560049 - CHU de Liège - Sart TilmanRecruiting
  • 2500146 - CHU De Dijon Hopital Du BocageRecruiting
  • 2500188 - Centre Hospitalier Regional Universitaire de LilleRecruiting
  • 2500133 - CHU - Hospital de la TimoneRecruiting
  • 2500135 - CHU Nice-Hopital Archet IRecruiting
  • 2500132 - Hopital Pitie-SalpetriereRecruiting
  • 2500144 - Hopitaux Universitaire de StrasbourgRecruiting
  • 2760203 - CharitéRecruiting
  • 2760211 - Charité - Universitätsmedizin BerlinRecruiting
  • 2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden
  • 2760036 - University Medicine GöttingenRecruiting
  • 2760201 - Medizinische Hochschule Hannover (MHH)Recruiting
  • 2760199 - University Hospital KölnRecruiting
  • 2760210 - University of MünsterRecruiting
  • 2760212 - University Hospital Of TuebingenRecruiting
  • 2760268 - University of UlmRecruiting
  • 3480048 - University of DebrecenRecruiting
  • 3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di BresciaRecruiting
  • 3800132 - Universitaria Vittorio EmanueleRecruiting
  • 3800139 - Universita degli Studi FirenzeRecruiting
  • 3800134 - Azienda Ospedaliero Universitaria PisanaRecruiting
  • 3920096 - Chukyo HospitalRecruiting
  • 3920090 - University Of Fukui HospitalRecruiting
  • 3920088 - Gunma University HospitalRecruiting
  • 3920089 - Hokkaido University HospitalRecruiting
  • 3920086 - St. Marianna University HospitalRecruiting
  • 3920125 - Tokyo Medical And Dental University Medical HospitalRecruiting
  • 3920091 - Nippon Medical School HospitalRecruiting
  • 3920097 - Tokyo Women's Medical University HospitalRecruiting
  • 3920087 - Wakayama Medical University HospitalRecruiting
  • 3920035 - Yamaguchi University HospitalRecruiting
  • 4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.Recruiting
  • 4840081 - Centro Integral en Reumatologia, SA de CVRecruiting
  • 4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.Recruiting
  • 6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2Recruiting
  • 6430124 - ORIS Firm Limited Liability Company
  • 6430122 - City Clinical Hospital No. 5
  • 6430125 - Medical Centre-Healthy Family
  • 6430120 - St. Petersburg City Rheumatological Hospital 25
  • 6430123 - Yaroslavl Oblast Clinical Hospital
  • 7240086 - Complejo Hospitalario Universitario A CoruñaRecruiting
  • 7240011 - Hospital Universitario Valle de HebronRecruiting
  • 7240112 - Hospital Clinic BarcelonaRecruiting
  • 7560033 - University Hospital Bern InselspitalRecruiting
  • 7560028 - Kantonsspital St. GallenRecruiting
  • 8040053 - Cherkassy Regional Hospital
  • 8040055 - Mechnikov Institute of Microbiology and Immunology
  • 8040057 - Khmelnitskiy Regional Hospital
  • 8040058 - State Institution National Scientific Center Strazhesko
  • 8040052 - Institute of Rheumatology
  • 8040051 - Kyiv Railway Clinical Hospital No.2
  • 8040054 - Modern Clinic LLC
  • 8260119 - Doncaster Royal InfirmaryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

IgPro20

Placebo

Arm Description

human immunoglobulin G administered subcutaneously

human albumin solution administered subcutaneously

Outcomes

Primary Outcome Measures

Responder Rate
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.

Secondary Outcome Measures

Mean Total Improvement Score (TIS)
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.
Mean difference (IgPro20 minus placebo) in TIS
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.
Mean changes from Baseline in Manual Muscle Testing (MMT-8)
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.
Mean change difference (IgPro20 minus placebo) in MMT-8
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.
Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score
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.
Mean change difference (IgPro20 minus placebo) in CDASI
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.
Mean TIS
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.
Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points
Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS
Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2
Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI
Mean changes in individual CSMs (except muscle enzymes) and CDASI
Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice
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%
Percentage of subjects meeting DOW at least once, twice, or > twice
Time to meeting DOW for the first time
Number of subjects meeting DOW and receiving rescue steroid treatment
Percentage of subjects meeting DOW and receiving rescue steroid treatment
Percentage of subjects receiving rescue steroid treatment
Percentage of subjects whose rescue steroid treatment is tapered
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)
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."
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
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
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
Percentage of subjects with Treatment Emergent Adverse Events (TEAEs)
Percentage of subjects with related TEAEs
Percentage of subjects with serious TEAEs
Rate of TEAEs per days with infusion
Rate of TEAEs per days with infusion, by severity
Rate of related TEAEs per days with infusion
Rate of serious TEAEs per days with infusion
Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
Number of subjects who start oral corticosteroid dose taper
Percentage of subjects who start oral corticosteroid dose taper
Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
Time to first intake of rescue corticosteroid treatment

Full Information

First Posted
August 1, 2019
Last Updated
October 24, 2023
Sponsor
CSL Behring
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1. Study Identification

Unique Protocol Identification Number
NCT04044690
Brief Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Acronym
RECLAIIM
Official Title
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Immunoglobulin, Hizentra®) in Adults With Dermatomyositis (DM) - The RECLAIIM Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2019 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
November 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSL Behring

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatomyositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IgPro20
Arm Type
Experimental
Arm Description
human immunoglobulin G administered subcutaneously
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
human albumin solution administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
human immunoglobulin G
Other Intervention Name(s)
IgPro20, Hizentra
Intervention Description
human immunoglobulin G administered subcutaneously
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
Primary Outcome Measure Information:
Title
Responder Rate
Description
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.
Time Frame
Weeks 17, 21, and 25
Secondary Outcome Measure Information:
Title
Mean Total Improvement Score (TIS)
Description
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.
Time Frame
Up to Week 25
Title
Mean difference (IgPro20 minus placebo) in TIS
Description
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.
Time Frame
Up to week 25
Title
Mean changes from Baseline in Manual Muscle Testing (MMT-8)
Description
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.
Time Frame
Up to week 25
Title
Mean change difference (IgPro20 minus placebo) in MMT-8
Description
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.
Time Frame
Up to week 25
Title
Mean changes from Baseline in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) total activity score
Description
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.
Time Frame
Up to week 25
Title
Mean change difference (IgPro20 minus placebo) in CDASI
Description
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.
Time Frame
Up to week 25
Title
Mean TIS
Description
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.
Time Frame
Week 5 up to Week 53
Title
Percentage of subjects achieving TIS ≥ 20, ≥ 40, and ≥ 60 points
Time Frame
Week 5 up to Week 53
Title
Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS
Time Frame
Week 5 up to Week 53
Title
Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2
Time Frame
Up to week 53
Title
Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI
Time Frame
Between Week 5 and Week 25
Title
Mean changes in individual CSMs (except muscle enzymes) and CDASI
Time Frame
From week 29 to week 53
Title
Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice
Description
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%
Time Frame
Baseline up to Week 53
Title
Percentage of subjects meeting DOW at least once, twice, or > twice
Time Frame
Baseline up to Week 53
Title
Time to meeting DOW for the first time
Time Frame
Baseline up to Week 53
Title
Number of subjects meeting DOW and receiving rescue steroid treatment
Time Frame
Baseline up to Week 53
Title
Percentage of subjects meeting DOW and receiving rescue steroid treatment
Time Frame
Baseline up to Week 53
Title
Percentage of subjects receiving rescue steroid treatment
Time Frame
Baseline up to Week 25
Title
Percentage of subjects whose rescue steroid treatment is tapered
Time Frame
Baseline up to Week 25
Title
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)
Description
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."
Time Frame
Baseline up to Week 53
Title
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
Title
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
Title
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
Title
Percentage of subjects with Treatment Emergent Adverse Events (TEAEs)
Time Frame
Up to week 197
Title
Percentage of subjects with related TEAEs
Time Frame
Up to week 197
Title
Percentage of subjects with serious TEAEs
Time Frame
Up to week 197
Title
Rate of TEAEs per days with infusion
Time Frame
Up to week 197
Title
Rate of TEAEs per days with infusion, by severity
Time Frame
Up to week 197
Title
Rate of related TEAEs per days with infusion
Time Frame
Up to week 197
Title
Rate of serious TEAEs per days with infusion
Time Frame
Up to week 197
Title
Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
Time Frame
Up to Week 25
Title
Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
Time Frame
Up to Week 25
Title
The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%
Time Frame
Up to Week 25
Title
Number of subjects who start oral corticosteroid dose taper
Time Frame
Baseline up to Week 53
Title
Percentage of subjects who start oral corticosteroid dose taper
Time Frame
Baseline up to Week 53
Title
Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
Time Frame
Baseline up to Week 25
Title
Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
Time Frame
Baseline up to Week 25
Title
Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75%
Time Frame
Baseline up to Week 53
Title
Time to first intake of rescue corticosteroid treatment
Time Frame
Baseline up to Week 25

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trial Registration Coordinator
Phone
610-878-4000
Email
clinicaltrials@cslbehring.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
CSL Behring
Official's Role
Study Director
Facility Information:
Facility Name
8401117 - Arizona Arthritis & Rheumatology Research
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401199 - Neuromuscular Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85028
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401129 - UCLA - Rheumatology Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401473 - RecioMed Clinical Research Network, Inc.
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401160 - Center For Rheumatology
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401132 - Omega Research Maitland
City
Orlando
State/Province
Florida
ZIP/Postal Code
32810
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401107 - Morsani Center for Advanced Health Care (CAHC)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33616
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401152 - The University of Kansas Medical Center
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401476 - DS Research
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40241
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401487 - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401486 - Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401210 - University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401151 - Biomedical Science Tower
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401474 - West Tennessee Research Institute, LLC
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8401115 - The University of Texas Medical School at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
0320083 - Hospital Italiano de Buenos Aires
City
Ciudad Autónoma Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
0560050 - Ghent Universit Hospital (UZ Gent)
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
0560048 - Universitair Ziekenhuis (UZ) Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
0560056 - Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
0560049 - CHU de Liège - Sart Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2500146 - CHU De Dijon Hopital Du Bocage
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2500188 - Centre Hospitalier Regional Universitaire de Lille
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2500133 - CHU - Hospital de la Timone
City
Marseille
ZIP/Postal Code
13385
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2500135 - CHU Nice-Hopital Archet I
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2500132 - Hopital Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2500144 - Hopitaux Universitaire de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760203 - Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760211 - Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760271 - Universitatsklinikum Carl Gustav Carus TU Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760036 - University Medicine Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760201 - Medizinische Hochschule Hannover (MHH)
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760199 - University Hospital Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760210 - University of Münster
City
Münster
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760212 - University Hospital Of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
2760268 - University of Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3480048 - University of Debrecen
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3800132 - Universitaria Vittorio Emanuele
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3800139 - Universita degli Studi Firenze
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3800134 - Azienda Ospedaliero Universitaria Pisana
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920096 - Chukyo Hospital
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920090 - University Of Fukui Hospital
City
Yoshida-Gun
State/Province
Fukui
ZIP/Postal Code
910-1193
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920088 - Gunma University Hospital
City
Maebashi City
State/Province
Gunma
ZIP/Postal Code
371-6511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920089 - Hokkaido University Hospital
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8648
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920086 - St. Marianna University Hospital
City
Kawasaki
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920125 - Tokyo Medical And Dental University Medical Hospital
City
Bunkyo
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920091 - Nippon Medical School Hospital
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920097 - Tokyo Women's Medical University Hospital
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920087 - Wakayama Medical University Hospital
City
Wakayama
ZIP/Postal Code
641-8509
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
3920035 - Yamaguchi University Hospital
City
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
City
Ciudad de México
State/Province
Distrito Federal
ZIP/Postal Code
11850
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
4840081 - Centro Integral en Reumatologia, SA de CV
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44160
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C.
City
San Luis Potosí
ZIP/Postal Code
78213
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2
City
Lublin
ZIP/Postal Code
20-582
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
6430124 - ORIS Firm Limited Liability Company
City
Moscow
ZIP/Postal Code
117321
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
6430122 - City Clinical Hospital No. 5
City
Nizhniy Novgorod
ZIP/Postal Code
603005
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
6430125 - Medical Centre-Healthy Family
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
6430120 - St. Petersburg City Rheumatological Hospital 25
City
Saint Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
6430123 - Yaroslavl Oblast Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
Individual Site Status
Active, not recruiting
Facility Name
7240086 - Complejo Hospitalario Universitario A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
7240011 - Hospital Universitario Valle de Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
7240112 - Hospital Clinic Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
7560033 - University Hospital Bern Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
7560028 - Kantonsspital St. Gallen
City
Saint Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Facility Name
8040053 - Cherkassy Regional Hospital
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8040055 - Mechnikov Institute of Microbiology and Immunology
City
Kharkiv
ZIP/Postal Code
61029
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8040057 - Khmelnitskiy Regional Hospital
City
Khmelnytskyi
ZIP/Postal Code
29000
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8040058 - State Institution National Scientific Center Strazhesko
City
Kiev
ZIP/Postal Code
03151
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8040052 - Institute of Rheumatology
City
Kyiv
ZIP/Postal Code
02081
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8040051 - Kyiv Railway Clinical Hospital No.2
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8040054 - Modern Clinic LLC
City
Zaporizhia
ZIP/Postal Code
69005
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
8260119 - Doncaster Royal Infirmary
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Use Central Contact

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
IPD Sharing Time Frame
IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
IPD Sharing Access Criteria
Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.

Learn more about this trial

A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)

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