- 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
Dermatomyositis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
NCT04044690 | Phase 3 | Interventional
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.
Trial Information
If interested, contact clinicaltrials@cslbehring.com for more information
Arizona Arthritis & Rheumatology Research
Glendale,Arizona,United States,85306
Neuromuscular Research Center
Phoenix,Arizona,United States,85028
UCLA Rheumatology Los Angeles
Los Angeles,California,United States,90095
Center For Rheumatology
Fort Lauderdale,Florida,United States,33334
Omega Research Maitland
Orlando,Florida,United States,32810
Morsani Center for Advanced Health Care (CAHC)
Tampa,Florida,United States,33616
The University of Kansas Medical Center
Fairway,Kansas,United States,66205
Northwell Health Physicians
Great Neck,New York,United States,11021
Paramount Medical Research & Consulting
Middleburg Heights,Ohio,United States,44130
University of Pennsylvania
Philadelphia,Pennsylvania,United States,19104
Biomedical Science Tower
Pittsburgh,Pennsylvania,United States,15261
The University of Texas Medical School at Houston
Houston,Texas,United States,77030
Ghent Universit Hospital (UZ Gent)
Gent,Belgium,9000
Universitair Ziekenhuis (UZ) Leuven
Leuven,Belgium,3000
CHU de Lige Sart Tilman
Liège,Belgium,4000
CHU De Dijon Hopital Du Bocage
Dijon,France,21079
CHU Hospital de la Timone
Marseille,France,13385
CHU NiceHopital Archet I
Nice,France,06202
Hopital PitieSalpetriere
Paris,France,75013
Hopitaux Universitaire de Strasbourg
Strasbourg,France,67098
Charit
Berlin,Germany,10117
Charit Universittsmedizin Berlin
Berlin,Germany,10117
University Essen
Essen,Germany,45147
University Medicine Gttingen
Göttingen,Germany,37075
Medizinische Hochschule Hannover (MHH)
Hannover,Germany,30625
University Hospital Kln
Köln,Germany,50937
University of Mnster
Münster,Germany,48149
Universita degli Studi Di Brescia Azienda Ospedaliera Spedali Civili di Brescia
Brescia,Italy,25123
Universitaria Vittorio Emanuele
Catania,Italy,95124
Universita degli Studi Firenze
Firenze,Italy,50134
Azienda Ospedaliero Universitaria Pisana
Pisa,Italy,56124
Chukyo Hospital
Nagoya,Japan,457-8510
University Of Fukui Hospital
Yoshida-Gun,Japan,910-1193
Gunma University Hospital
Maebashi City,Japan,371-6511
Hokkaido University Hospital
Sapporo,Japan,060-8648
St. Marianna University Hospital
Kawasaki,Japan,216-8511
Tokyo Medical And Dental University Medical Hospital
Bunkyo,Japan,113-8519
Nippon Medical School Hospital
Bunkyō-Ku,Japan,113-8603
Tokyo Women's Medical University Hospital
Shinjuku-Ku,Japan,162-8666
Wakayama Medical University Hospital
Wakayama,Japan,641-8509
Yamaguchi University Hospital
Yamaguchi,Japan,755-8505
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
Ciudad de México,Mexico,11850
Centro Integral en Reumatologia, SA de CV
Guadalajara,Mexico,44160
Centro de Alta Especialidad en Reumatologia e Investigacion del Potos, S.C.
San Luis Potosí,Mexico,78213
Amsterdam Universitair Medische Centra (UMC)
Amsterdam,Netherlands,1105 AZ
Specjalistyczne Gabinety Sp. z o.o
Krakow,Poland,30-539
Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr
Lublin,Poland,20-582
Complejo Hospitalario Universitario A Corua
A Coruña,Spain,15006
Hospital Universitario Valle de Hebron
Barcelona,Spain,08035
Kantonsspital St. Gallen
Saint Gallen,Switzerland,9007
Doncaster Royal Infirmary
Doncaster,United Kingdom,DN2 5LT
Study Eligibility 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
Additional Studies
Additional studies can be found at ClinicalTrials.gov