RECLAIIM: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IgPro20 human immunoglobulin G administered subcutaneously |
Drug: human immunoglobulin G
human immunoglobulin G administered subcutaneously
Other Names:
|
Placebo Comparator: Placebo human albumin solution administered subcutaneously |
Drug: Placebo
contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
|
Outcome Measures
Primary Outcome Measures
- Responder Rate [Weeks 17, 21, and 25]
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) [Up to Week 25]
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 [Up to week 25]
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) [Up to week 25]
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 [Up to week 25]
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 [Up to week 25]
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 [Up to week 25]
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 [Week 5 up to Week 53]
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 [Week 5 up to Week 53]
- Time to first achieving TIS ≥ 20, ≥ 40, and ≥ 60 points on the TIS [Week 5 up to Week 53]
- Percentage of subjects achieving TIS ≥ 20 points at the end of study period 2 [Up to week 53]
- Mean changes from baseline in individual CSMs (except muscle enzymes) and CDASI [Between Week 5 and Week 25]
- Mean changes in individual CSMs (except muscle enzymes) and CDASI [From week 29 to week 53]
- Number of subjects meeting Definition of Worsening (DOW) at least once, twice, or > twice [Baseline up to Week 53]
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 [Baseline up to Week 53]
- Time to meeting DOW for the first time [Baseline up to Week 53]
- Number of subjects meeting DOW and receiving rescue steroid treatment [Baseline up to Week 53]
- Percentage of subjects meeting DOW and receiving rescue steroid treatment [Baseline up to Week 53]
- Percentage of subjects receiving rescue steroid treatment [Baseline up to Week 25]
- Percentage of subjects whose rescue steroid treatment is tapered [Baseline 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) [Baseline up to Week 53]
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 [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 [From Week 25 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 [From Week 25 up to week 53]
- Percentage of subjects with Treatment Emergent Adverse Events (TEAEs) [Up to week 197]
- Percentage of subjects with related TEAEs [Up to week 197]
- Percentage of subjects with serious TEAEs [Up to week 197]
- Rate of TEAEs per days with infusion [Up to week 197]
- Rate of TEAEs per days with infusion, by severity [Up to week 197]
- Rate of related TEAEs per days with infusion [Up to week 197]
- Rate of serious TEAEs per days with infusion [Up to week 197]
- Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [Up to Week 25]
- Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [Up to Week 25]
- The odds ratio (IgPro20:Placebo) of subjects who are able to reduce the oral corticosteroid dose by ≥ 25% [Up to Week 25]
- Number of subjects who start oral corticosteroid dose taper [Baseline up to Week 53]
- Percentage of subjects who start oral corticosteroid dose taper [Baseline up to Week 53]
- Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [Baseline up to Week 25]
- Percentage of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [Baseline up to Week 25]
- Number of subjects who are able to reduce the oral corticosteroid dose by ≥ 25%, ≥ 50%, ≥ 75% [Baseline up to Week 53]
- Time to first intake of rescue corticosteroid treatment [Baseline up to Week 25]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects ≥ 18 years of age
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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
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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.
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Corticosteroid daily dose less than that or equal to 20 mg prednisolone equivalent
Exclusion Criteria:
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Cancer-associated myositis
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Evidence of active malignant disease or malignancies diagnosed within the previous 5 years
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Physician Global Damage score ≥ 3, or clinically relevant improvement between Screening Visit and Baseline
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | 8401117 - Arizona Arthritis & Rheumatology Research | Glendale | Arizona | United States | 85306 |
2 | 8401199 - Neuromuscular Research Center | Phoenix | Arizona | United States | 85028 |
3 | 8401129 - UCLA - Rheumatology Los Angeles | Los Angeles | California | United States | 90095 |
4 | 8401473 - RecioMed Clinical Research Network, Inc. | Boynton Beach | Florida | United States | 33472 |
5 | 8401160 - Center For Rheumatology | Fort Lauderdale | Florida | United States | 33334 |
6 | 8401132 - Omega Research Maitland | Orlando | Florida | United States | 32810 |
7 | 8401107 - Morsani Center for Advanced Health Care (CAHC) | Tampa | Florida | United States | 33616 |
8 | 8401152 - The University of Kansas Medical Center | Fairway | Kansas | United States | 66205 |
9 | 8401476 - DS Research | Louisville | Kentucky | United States | 40241 |
10 | 8401111 - Ochsner Clinic Foundation | Baton Rouge | Louisiana | United States | 70809 |
11 | 8401130 - University Of Michigan | Ann Arbor | Michigan | United States | 48106 |
12 | 8401181 - Northwell Health Physicians | Great Neck | New York | United States | 11021 |
13 | 8400169 - HSS-Weill Medical College of Cornell University | New York | New York | United States | 10021 |
14 | 8401487 - Ohio State University | Columbus | Ohio | United States | 43210 |
15 | 8401131 - Paramount Medical Research & Consulting | Middleburg Heights | Ohio | United States | 44130 |
16 | 8401486 - Oregon Health and Science University | Portland | Oregon | United States | 97239 |
17 | 8401210 - University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
18 | 8401151 - Biomedical Science Tower | Pittsburgh | Pennsylvania | United States | 15261 |
19 | 8401113 - Wesley Neurology Clinic | Cordova | Tennessee | United States | 38018 |
20 | 8401474 - West Tennessee Research Institute, LLC | Jackson | Tennessee | United States | 38305 |
21 | 8401115 - The University of Texas Medical School at Houston | Houston | Texas | United States | 77030 |
22 | 0360094 - Murdoch University | Murdoch | Western Australia | Australia | 6150 |
23 | 0560050 - Ghent Universit Hospital (UZ Gent) | Gent | Belgium | 9000 | |
24 | 0560048 - Universitair Ziekenhuis (UZ) Leuven | Leuven | Belgium | 3000 | |
25 | 0560049 - CHU de Liège - Sart Tilman | Liège | Belgium | 4000 | |
26 | 2500146 - CHU De Dijon Hopital Du Bocage | Dijon | France | 21079 | |
27 | 2500188 - Centre Hospitalier Regional Universitaire de Lille | Lille Cedex | France | 59037 | |
28 | 2500133 - CHU - Hospital de la Timone | Marseille | France | 13385 | |
29 | 2500135 - CHU Nice-Hopital Archet I | Nice | France | 06202 | |
30 | 2500132 - Hopital Pitie-Salpetriere | Paris | France | 75013 | |
31 | 2500144 - Hopitaux Universitaire de Strasbourg | Strasbourg | France | 67098 | |
32 | 2760203 - Charité | Berlin | Germany | 10117 | |
33 | 2760211 - Charité - Universitätsmedizin Berlin | Berlin | Germany | 10117 | |
34 | 2760094 - University Essen | Essen | Germany | 45147 | |
35 | 2760036 - University Medicine Göttingen | Göttingen | Germany | 37075 | |
36 | 2760197 - Universitätsklinikum Hamburg-Eppendorf (UKE) | Hamburg | Germany | 20246 | |
37 | 2760201 - Medizinische Hochschule Hannover (MHH) | Hannover | Germany | 30625 | |
38 | 2760199 - University Hospital Köln | Köln | Germany | 50937 | |
39 | 2760210 - University of Münster | Münster | Germany | 48149 | |
40 | 2760212 - University Hospital Of Tuebingen | Tuebingen | Germany | 72076 | |
41 | 2760268 - University of Ulm | Ulm | Germany | 89081 | |
42 | 3800133 - Universita degli Studi Di Brescia - Azienda Ospedaliera Spedali Civili di Brescia | Brescia | Italy | 25123 | |
43 | 3800132 - Universitaria Vittorio Emanuele | Catania | Italy | 95124 | |
44 | 3800139 - Universita degli Studi Firenze | Firenze | Italy | 50134 | |
45 | 3800134 - Azienda Ospedaliero Universitaria Pisana | Pisa | Italy | 56124 | |
46 | 3800135 - University of Sacred Heart Policlinico A. Gemelli | Roma | Italy | 00168 | |
47 | 3920096 - Chukyo Hospital | Nagoya | Aichi | Japan | 457-8510 |
48 | 3920090 - University Of Fukui Hospital | Yoshida-Gun | Fukui | Japan | 910-1193 |
49 | 3920088 - Gunma University Hospital | Maebashi City | Gunma | Japan | 371-6511 |
50 | 3920089 - Hokkaido University Hospital | Sapporo | Hokkaido | Japan | 060-8648 |
51 | 3920086 - St. Marianna University Hospital | Kawasaki | Kanagawa | Japan | 216-8511 |
52 | 3920125 - Tokyo Medical And Dental University Medical Hospital | Bunkyo | Tokyo | Japan | 113-8519 |
53 | 3920091 - Nippon Medical School Hospital | Bunkyō-Ku | Tokyo | Japan | 113-8603 |
54 | 3920097 - Tokyo Women's Medical University Hospital | Shinjuku-Ku | Tokyo | Japan | 162-8666 |
55 | 3920087 - Wakayama Medical University Hospital | Wakayama | Japan | 641-8509 | |
56 | 3920035 - Yamaguchi University Hospital | Yamaguchi | Japan | 755-8505 | |
57 | 4840082 - CINTRE, Centro de Investigacion y Tratamiento Reumatologico S.C. | Ciudad de México | Distrito Federal | Mexico | 11850 |
58 | 4840081 - Centro Integral en Reumatologia, SA de CV | Guadalajara | Jalisco | Mexico | 44160 |
59 | 4840084 - Centro de Alta Especialidad en Reumatologia e Investigacion del Potosí, S.C. | San Luis Potosí | Mexico | 78213 | |
60 | 5280065 - Amsterdam Universitair Medische Centra (UMC) | Amsterdam | Netherlands | 1105 AZ | |
61 | 6160106 - Specjalistyczne Gabinety Sp. z o.o | Krakow | Poland | 30-539 | |
62 | 6160104 - Zespol Poradni Specjalistycznych REUMED, ONYKSOWA Filia nr 2 | Lublin | Poland | 20-582 | |
63 | 6160105 - Samodzielny Publiczny Szpital | Szczecin | Poland | 70-111 | |
64 | 6430124 - ORIS Firm Limited Liability Company | Moscow | Russian Federation | 117321 | |
65 | 6430122 - City Clinical Hospital No. 5 | Nizhniy Novgorod | Russian Federation | 603005 | |
66 | 6430125 - Medical Centre-Healthy Family | Novosibirsk | Russian Federation | 630099 | |
67 | 6430120 - St. Petersburg City Rheumatological Hospital 25 | Saint Petersburg | Russian Federation | 190068 | |
68 | 6430123 - Yaroslavl Oblast Clinical Hospital | Yaroslavl | Russian Federation | 150007 | |
69 | 7240086 - Complejo Hospitalario Universitario A Coruña | A Coruña | Spain | 15006 | |
70 | 7240011 - Hospital Universitario Valle de Hebron | Barcelona | Spain | 08035 | |
71 | 7560033 - University Hospital Bern Inselspital | Bern | Switzerland | 3010 | |
72 | 7560028 - Kantonsspital St. Gallen | Saint Gallen | Switzerland | 9007 | |
73 | 8040053 - Cherkassy Regional Hospital | Cherkasy | Ukraine | 18009 | |
74 | 8040055 - Mechnikov Institute of Microbiology and Immunology | Kharkiv | Ukraine | 61029 | |
75 | 8040057 - Khmelnitskiy Regional Hospital | Khmelnytskyi | Ukraine | 29000 | |
76 | 8040058 - State Institution National Scientific Center Strazhesko | Kiev | Ukraine | 03151 | |
77 | 8040052 - Institute of Rheumatology | Kyiv | Ukraine | 02081 | |
78 | 8040051 - Kyiv Railway Clinical Hospital No.2 | Kyiv | Ukraine | 03049 | |
79 | 8040054 - Modern Clinic LLC | Zaporizhia | Ukraine | 69005 | |
80 | 8260119 - Doncaster Royal Infirmary | Doncaster | United Kingdom | DN2 5LT |
Sponsors and Collaborators
- CSL Behring
Investigators
- Study Director: Study Director, CSL Behring
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IgPro20_3007
- 2018-003171-35