- * 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
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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
RecioMed Clinical Research Network, Inc.
Boynton Beach,Florida,United States,33472
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
DS Research
Louisville,Kentucky,United States,40241
Ohio State University
Columbus,Ohio,United States,43210
Oregon Health and Science University
Portland,Oregon,United States,97239
University of Pennsylvania
Philadelphia,Pennsylvania,United States,19104
Biomedical Science Tower
Pittsburgh,Pennsylvania,United States,15261
West Tennessee Research Institute, LLC
Jackson,Tennessee,United States,38305
The University of Texas Medical School at Houston
Houston,Texas,United States,77030
Hospital Italiano de Buenos Aires
Ciudad Autónoma Buenos Aires,Buenos Aires,Argentina,C1181ACH
DIM Clinica Privada
Buenos Aires,Buenos Aires,Argentina,B1704ETD
Fundacion Respirar
Buenos Aires,Buenos Aires,Argentina,C1426ABP
Centro Medico Privado de Reumatolgia
Tucumán,Buenos Aires,Argentina,T4000
Ghent Universit Hospital (UZ Gent)
Gent,Buenos Aires,Belgium,9000
Universitair Ziekenhuis (UZ) Leuven
Leuven,Buenos Aires,Belgium,3000
Universitair Ziekenhuis Leuven
Leuven,Buenos Aires,Belgium,3000
CHU de Lige Sart Tilman
Liège,Buenos Aires,Belgium,4000
CHU De Dijon Hopital Du Bocage
Dijon,Buenos Aires,France,21079
Centre Hospitalier Regional Universitaire de Lille
Lille Cedex,Buenos Aires,France,59037
CHU Hospital de la Timone
Marseille,Buenos Aires,France,13385
CHU NiceHopital Archet I
Nice,Buenos Aires,France,06202
Hopital PitieSalpetriere
Paris,Buenos Aires,France,75013
Hopitaux Universitaire de Strasbourg
Strasbourg,Buenos Aires,France,67098
Charit
Berlin,Buenos Aires,Germany,10117
Charit Universittsmedizin Berlin
Berlin,Buenos Aires,Germany,10117
Universitatsklinikum Carl Gustav Carus TU Dresden
Dresden,Buenos Aires,Germany,01307
Hautklinik des UniKlinikums Erlangen
Erlangen,Buenos Aires,Germany,91504
University Medicine Gttingen
Göttingen,Buenos Aires,Germany,37075
Medizinische Hochschule Hannover (MHH)
Hannover,Buenos Aires,Germany,30625
University Hospital Kln
Köln,Buenos Aires,Germany,50937
University of Mnster
Münster,Buenos Aires,Germany,48149
University Hospital Of Tuebingen
Tuebingen,Buenos Aires,Germany,72076
University of Ulm
Ulm,Buenos Aires,Germany,89081
University of Debrecen
Debrecen,Buenos Aires,Hungary,4032
Universita degli Studi Di Brescia Azienda Ospedaliera Spedali Civili di Brescia
Brescia,Buenos Aires,Italy,25123
Universitaria Vittorio Emanuele
Catania,Buenos Aires,Italy,95124
Universita degli Studi Firenze
Firenze,Buenos Aires,Italy,50134
Azienda Ospedaliero Universitaria Pisana
Pisa,Buenos Aires,Italy,56124
Chukyo Hospital
Nagoya,Aichi,Japan,457-8510
University Of Fukui Hospital
Yoshida-Gun,Fukui,Japan,910-1193
Gunma University Hospital
Maebashi City,Gunma,Japan,371-6511
Hokkaido University Hospital
Sapporo,Hokkaido,Japan,060-8648
St. Marianna University Hospital
Kawasaki,Kanagawa,Japan,216-8511
Tokyo Medical And Dental University Medical Hospital
Bunkyo,Tokyo,Japan,113-8519
Nippon Medical School Hospital
Bunkyō-Ku,Tokyo,Japan,113-8603
Tokyo Women's Medical University Hospital
Shinjuku-Ku,Tokyo,Japan,162-8666
Wakayama Medical University Hospital
Wakayama,Tokyo,Japan,641-8509
Yamaguchi University Hospital
Yamaguchi,Tokyo,Japan,755-8505
CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C.
Ciudad de México,Distrito Federal,Mexico,11850
Centro Integral en Reumatologia, SA de CV
Guadalajara,Jalisco,Mexico,44160
Centro de Alta Especialidad en Reumatologia e Investigacion del Potos, S.C.
San Luis Potosí,Jalisco,Mexico,78213
Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr
Lublin,Jalisco,Poland,20-582
MedicalConcierge Centrum Medyczne
Warszawa,Jalisco,Poland,02-798
ORIS Firm Limited Liability Company
Moscow,Jalisco,Russian Federation,117321
City Clinical Hospital No.
Nizhniy Novgorod,Jalisco,Russian Federation,603005
Medical CentreHealthy Family
Novosibirsk,Jalisco,Russian Federation,630099
St. Petersburg City Rheumatological Hospital
Saint Petersburg,Jalisco,Russian Federation,190068
Yaroslavl Oblast Clinical Hospital
Yaroslavl,Jalisco,Russian Federation,150007
Complejo Hospitalario Universitario A Corua
A Coruña,Jalisco,Spain,15006
Hospital Universitario Valle de Hebron
Barcelona,Jalisco,Spain,08035
Hospital Clinic Barcelona
Barcelona,Jalisco,Spain,08036
University Hospital Bern Inselspital
Bern,Jalisco,Switzerland,3010
Kantonsspital St. Gallen
Saint Gallen,Jalisco,Switzerland,9007
Cherkassy Regional Hospital
Cherkasy,Jalisco,Ukraine,18009
Mechnikov Institute of Microbiology and Immunology
Kharkiv,Jalisco,Ukraine,61029
Khmelnitskiy Regional Hospital
Khmelnytskyi,Jalisco,Ukraine,29000
State Institution National Scientific Center Strazhesko
Kiev,Jalisco,Ukraine,03151
Institute of Rheumatology
Kyiv,Jalisco,Ukraine,02081
Kyiv Railway Clinical Hospital No.
Kyiv,Jalisco,Ukraine,03049
Modern Clinic LLC
Zaporizhia,Jalisco,Ukraine,69005
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov