MuSicalE: Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis
Study Details
Study Description
Brief Summary
This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Ocrelizumab Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care. |
Drug: Ocrelizumab
Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Changes in the overall SymptoMScreen score in participants with RMS [4 years]
SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)
- Changes in the overall SymptoMScreen score in participants with PPMS [4 years]
SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)
Secondary Outcome Measures
- Percentage of RMS Participants with Adverse Events [4 years]
- Percentage of PPMS participants with Adverse Events [4 years]
- Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS [4 years]
- Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS [4 years]
- Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants [4 years]
- Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants [4 years]
- Change in the score of ABILHAND - 56 scale in RMS participants [4 years]
- Change in the score of ABILHAND - 56 scale in PPMS participants [4 years]
- Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant [4 years]
- Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants [4 years]
- Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants [4 years]
- Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants [4 years]
- Change in the score of MSWS - 12 scale in RMS participants [4 years]
- Change in the score of MSWS - 12 scale in PPMS participants [4 years]
- Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in RMS Participants [4 years]
- Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in PPMS Participants [4 years]
- Frequency of relapses over time in RMS patients [4 years]
- Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time [4 years]
- Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time [4 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Must have a definite diagnosis of RMS or PPMS and in whom a decision to initiate ocrelizumab has been taken as part of routine clinical practice
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Must be prescribed ocrelizumab in line with the SmPC
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Must have provided signed informed consent
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Must be able and willing to complete the PROs as per clinical practice
Exclusion Criteria:
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Previously treated with ocrelizumab (including phase II, phase III and phase IIIB clinical trials, local trials and investigator initiated study (IIS) as well as a pre-approval access or compassionate use programmes or local registries that are not compatible with the MuSicalE study design)
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Not receiving ocrelizumab in line with the SmPC
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Landesklinikum Amstetten; Abteilung für Kinder- und Jugendheilkunde | Amstetten | Austria | 3300 | |
2 | Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie | Innsbruck | Austria | 6020 | |
3 | Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie | Linz | Austria | 4020 | |
4 | Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie | Linz | Austria | 4021 | |
5 | Multiple Sklerose Zentrum | Melk | Austria | 3390 | |
6 | Otto Wagner Spital; Neurologisches Zentrum | Wien | Austria | 1140 | |
7 | Imeldaziekenhuis | Bonheiden | Belgium | 2820 | |
8 | AZ KLINA | Brasschaat | Belgium | 2930 | |
9 | UZ Brussel | Brussel | Belgium | 1090 | |
10 | Hospital Erasme | Bruxelles | Belgium | 1070 | |
11 | Cliniques Universitaires St-Luc | Bruxelles | Belgium | 1200 | |
12 | CHU de Charleroi | Charleroi | Belgium | 6042 | |
13 | UZ Antwerpen | Edegem | Belgium | 2650 | |
14 | CNRF - Centre Neurologique et Réadaptation Fonctionnelle | Fraiture | Belgium | 4557 | |
15 | Jessa Zkh (Campus Virga Jesse) | Hasselt | Belgium | 3500 | |
16 | AZ Groeninge | Kortrijk | Belgium | 8500 | |
17 | CHU Tivoli | La Louvière | Belgium | 7100 | |
18 | CHC MontLégia | Liege | Belgium | 4000 | |
19 | Nationaal MS Centrum | Melsbroek | Belgium | 1820 | |
20 | CHU UCL Mont-Godinne | Mont-godinne | Belgium | 5530 | |
21 | AZ Damiaan | Oostende | Belgium | 8400 | |
22 | Revalidatie en MS Centrum | Overpelt | Belgium | 3900 | |
23 | AZ Delta (Campus Rumbeke) | Roeselare | Belgium | 8800 | |
24 | Clinica Amo - Assistencia Medica Em Oncologia | Salvador | BA | Brazil | 41950640 |
25 | Hospital de Base do Distrito Federal; Núcleo de Citopatologia e Anatomia Patológica | Brasilia | DF | Brazil | 70330-150 |
26 | Instituto de Neurologia de Curitiba | Curitiba | PR | Brazil | 81210-310 |
27 | Hospital Universitario Gaffree e Guinle | Rio de Janeiro | RJ | Brazil | 20270-004 |
28 | CPQuali Pesquisa Clinica Ltda | Sao Paulo | SP | Brazil | 01228-000 |
29 | Centro de Pesquisas Clinicas; CPCLIN | Sao Paulo | SP | Brazil | 01228-200 |
30 | UMHAT 'Dr. Georgi Stranski', EAD | Pleven | Bulgaria | 5800 | |
31 | UMHAT Sveti Georgi Clinic of neurology | Plovdiv | Bulgaria | 4000 | |
32 | Shat Np Sveti Naum; 3Rd Clinic of Neurology | Sofia | Bulgaria | 1113 | |
33 | First MHAT; Clinic of Neurology | Sofia | Bulgaria | 1142 | |
34 | Multiprofile Hosp. for Active Treatment;National Cardiology Hosp. | Sofia | Bulgaria | 1309 | |
35 | "City Clinic UMHAC" EOOD | Sofia | Bulgaria | 1407 | |
36 | ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine | Sofia | Bulgaria | 1407 | |
37 | UMHAT "Sv. Ivan Rilski", EAD | Sofia | Bulgaria | 1431 | |
38 | UMHAT Alexandrovska, EAD; Neurology | Sofia | Bulgaria | 1431 | |
39 | UMHAT Tsaritsa Yoanna - ISUL EAD; Clinic of Neurology | Sofia | Bulgaria | 1527 | |
40 | MBAL St. Marina; First Neurology Department | Varna | Bulgaria | 9010 | |
41 | Clinica Las Condes | Santiago | Chile | 7591046 | |
42 | Organizacion Sanitas Internacional | Bogota, D.C. | Colombia | 111321 | |
43 | Fundacion ABOOD Shaio | Bogota, DC | Colombia | ||
44 | Centro Javeriano de Oncología | Bogota | Colombia | ||
45 | Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas | Cali | Colombia | ||
46 | Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART) | Santo Domingo | Dominican Republic | ||
47 | Faculty of Medicine-Ain Shams University; Neurology Department | Cairo | Egypt | 1156 6111 | |
48 | Clinical Research Center-Alex university; Neurology Department | Cairo | Egypt | 21561 | |
49 | Al Azhar University Hospital | Cairo | Egypt | ||
50 | Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla | L'Aquila | Abruzzo | Italy | 67100 |
51 | Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur | Napoli | Campania | Italy | 80131 |
52 | AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica | Napoli | Campania | Italy | 80138 |
53 | Arcispedale Sant'Anna; Neurochirurgia - Dipartimento Neuroscienze e Riabilitazione | Cona | Emilia-Romagna | Italy | 44124 |
54 | A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti) | Parma | Emilia-Romagna | Italy | 43126 |
55 | Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Roma | Lazio | Italy | 00133 |
56 | Azienda Ospedaliera Sant'Andrea; UOC Neurologia | Roma | Lazio | Italy | 00189 |
57 | Irccs A.O.U.San Martino Ist; Dinogmi | Genova | Liguria | Italy | 16132 |
58 | Presidio Ospedaliero S.O.P.A. Micone; S.C. Neurologia, Centro Sclerosi Multipla | Sestri Ponente (GE) | Liguria | Italy | 16153 |
59 | Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico | Gallarate | Lombardia | Italy | 21013 |
60 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia | Milano | Lombardia | Italy | 20122 |
61 | IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla | Milano | Lombardia | Italy | 20132 |
62 | Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari | Milano | Lombardia | Italy | 20133 |
63 | IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla | Pavia | Lombardia | Italy | 27100 |
64 | Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona | Torrette - Ancona | Marche | Italy | 60100 |
65 | IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla | Pozzilli | Molise | Italy | 86077 |
66 | Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla | Mondovì (CN) | Piemonte | Italy | 12084 |
67 | Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso | Bari | Puglia | Italy | 70124 |
68 | Ospedale F. Ferrari; UO Neurologia, Centro Sclerosi Multipla | Casarano | Puglia | Italy | 73042 |
69 | Ospedale Binaghi; Centro Sclerosi Multipla | Cagliari | Sardegna | Italy | 09126 |
70 | AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla | Catania | Sicilia | Italy | 95123 |
71 | AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla | Palermo | Sicilia | Italy | 90129 |
72 | AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale | Siena | Toscana | Italy | 53100 |
73 | Ibn Sina Hospital; Neurology Department | Kuwait | Kuwait | 10002 | |
74 | Clinical Center of Montenegro; Clinic for neurology | Podgorica | Montenegro | 20000 | |
75 | Amphia Ziekenhuis | Breda | Netherlands | 4819 EV | |
76 | St. Antonius Ziekenhuis Nieuwegein | Nieuwegein | Netherlands | 3435 CM | |
77 | Maasstadziekenhuis | Rotterdam | Netherlands | 3079 DZ | |
78 | Ziekenhuis VieCuri Medisch Centrum | Venlo | Netherlands | 5912 BL | |
79 | Isala | Zwolle | Netherlands | 8025 AB | |
80 | Consultorio Médico Paitilla | Ciudad Panama | Panama | ||
81 | Hospital Central del Instituto de Previsión Social | Asunción | Paraguay | ||
82 | Uniwersytecki Szpital Kliniczny w Bialymstoku | Białystok | Poland | 15-276 | |
83 | COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny | Gdansk | Poland | 80-803 | |
84 | Szpital Specjalistyczny im. Swiętej Rodziny w Rudnej Małej k. Rzeszowa | Glogow Malopolski | Poland | 36-060 | |
85 | Gornoslaskie Centrum Medyczne | Katowice | Poland | 40-635 | |
86 | UCK im. prof. K. Gibinskiego SUM; Klinika Neurologii | Katowice | Poland | 40-752 | |
87 | SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii | Lodz | Poland | 90-153 | |
88 | SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 | Rybnik | Poland | 44-200 | |
89 | Instytut Psychiatrii i Neurologii | Warszawa | Poland | 02-957 | |
90 | Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON | Warszawa | Poland | 04-141 | |
91 | SPSK nr 1; Klinika Neurologii | Zabrze | Poland | 41-800 | |
92 | Hospital Santo Antonio dos Capuchos; Servico de Neurologia | Lisboa | Portugal | 1169-050 | |
93 | Centro Hospitalar do Porto; CICAP - Unidade Clínica de Paramiloidose | Porto | Portugal | 4000-436 | |
94 | Hamad General Hospital; Neurology Department | Doha | Qatar | 3050 | |
95 | Fundeni Clinical Institute | Bucharest | Romania | 022328 | |
96 | Spitalul Universitar de Urgenta Bucuresti | Bucharest | Romania | 11172 | |
97 | Spitalul Clinic Judetean de Urgenta Cluj-Napoca; Neurologie | Cluj-Napoca | Romania | 400012 | |
98 | Spitalul Clinic Judetean de Urgenta Sibiu; Neurologie | Sibiu | Romania | 550166 | |
99 | Spitalul Clinic Judetean de Urgenta Mures | Targu-Mures | Romania | 540136 | |
100 | National Center of Social Significant Disease | Sankt-peterburg | Leningrad | Russian Federation | 197110 |
101 | Jusupovskaya Hospital | Moscow | Moskovskaja Oblast | Russian Federation | 117186 |
102 | Regional clinical hospital named after prof. S.V. Ochapovsky | Krasnodar | Russian Federation | 350086 | |
103 | State Novosibirsk Regional Clinical Hospital | Novosibirsk | Russian Federation | 630087 | |
104 | King Abdul Aziz Medical City, King Fahd National Guard; Oncology | Riyadh | Saudi Arabia | 22490 | |
105 | Clinical Center of Serbia | Belgrade | Serbia | 11000 | |
106 | Clinical Center Kragujevac | Kragujevac | Serbia | 34000 | |
107 | Clinical Center Nis | NIS | Serbia | 18000 | |
108 | Clinical Centre of Vojvodina | Nova Sad | Serbia | 21000 | |
109 | Univerzitna Nemocnica - Nemocnica svateho Michala; Neurologicke oddelenie | Bratislava | Slovakia | 811 08 | |
110 | UN Bratislava Nemocnica Ruzinov; Neurologicka klinika | Bratislava | Slovakia | 826 06 | |
111 | Nemocnica akademika Ladislava Derera; Neurologicka klinika | Bratislava | Slovakia | 833 05 | |
112 | Univerzitna nemocnica Martin; Neurologicka klinika | Martin | Slovakia | 036 59 | |
113 | Ustredna vojenska nemocnica SNP Ruzomberok; Klinika neurologie | Ruzomberok | Slovakia | ||
114 | Fakultna nemocnica Trnava | Trnava | Slovakia | 917 75 | |
115 | Hospital Universitario de Araba; Servicio de Neurologia | Vitoria-gasteiz | Alava | Spain | 1009 |
116 | Hospital General Universitario de Elche; Servicio de Neurología | Elche | Alicante | Spain | 03203 |
117 | Corporació Sanitaria Parc Taulí; Servicio de Neurología | Sabadell | Barcelona | Spain | 08208 |
118 | Hospital de Figueres; Servicio de Neurología | Figueres | Girona | Spain | 17600 |
119 | Hospital de Donostia; Servicio de Neurologia | San Sebastian | Guipuzcoa | Spain | 20014 |
120 | Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia | Coruña | LA Coruña | Spain | 15006 |
121 | Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia | Santiago de Compostela | LA Coruña | Spain | 15706 |
122 | Hospital General Universitario Santa Lucia; Servicio de Neurología | Cartagena (Murcia) | Murcia | Spain | 30202 |
123 | Hospital Universitario Virgen de Arrixaca; Servicio de Neurología | EL Palmar (EL Palmar) | Murcia | Spain | 30120 |
124 | Hospital Alvaro Cunqueiro; Servicio de Neurologia | Vigo | Pontevedra | Spain | |
125 | Hospital Universitario de Canarias; Servicio de Neurologia | San Cristóbal de La Laguna | Tenerife | Spain | |
126 | Hospital Nuestra Señora de Candelaria; Unidad de Esclerosis Multiple | Santa Cruz de Tenerife | Tenerife | Spain | |
127 | Hospital Nuestra Señora de Sonsoles; Servicio de Neurología | Avila | Spain | 05071 | |
128 | Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia | Barcelona | Spain | 08041 | |
129 | Hospital Germans Trias i Pujol | Barcelona | Spain | 08916 | |
130 | Hospital Puerta del Mar; Sevicio de Neurologia | Cadiz | Spain | 11009 | |
131 | Hospital Universitario Reina Sofia; Servicio de Neurologia | Cordoba | Spain | 14004 | |
132 | Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia | Malaga | Spain | 29010 | |
133 | Hospital Universitario Virgen de la Victoria; Servicio de Neurología | Malaga | Spain | 29010 | |
134 | Hospital Universitario Virgen Macarena; Servicio de Neurologia | Sevilla | Spain | 41009 | |
135 | Hospital Virgen del Rocío; Servicio de Neurología | Sevilla | Spain | 41013 | |
136 | Hospital Univ. Nuestra Señora de Valme; Servicio de Neurología | Sevilla | Spain | 41014 | |
137 | Hospital Clinico Universitario de Valencia; Servicio de Neurologia | Valencia | Spain | 46010 | |
138 | Hospital General Universitario de Valencia; Servicio de Neurología | Valencia | Spain | 46014 | |
139 | Hospital Universitario Dr. Peset; Servicio de Neurologia | Valencia | Spain | 46017 | |
140 | Hospital Universitari i Politecnic La Fe; Servicio de Neurología | Valencia | Spain | 46026 | |
141 | Hacettepe University Medical Faculty; Neurology | Ankara | Turkey | 06100 | |
142 | Istanbul University Istanbul School of Medicine; Neurology | Istanbul | Turkey | 34093 | |
143 | Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali | Istanbul | Turkey | 34098 | |
144 | Ege University Medical Faculty | Izmir | Turkey | 35100 | |
145 | Kocaeli University Hospital; Department of Neurology | Kocaeli | Turkey | 41380 | |
146 | Mersin University Medical Faculty; Neurology | Mersin | Turkey | 33079 | |
147 | Ondokuz Mayis Univ. Med. Fac.; Neurology | Samsun | Turkey | 55139 | |
148 | Karadeniz Tecnical Uni. Med. Fac.; Neurology | Trabzon | Turkey | 61080 | |
149 | Sheikh Shakhbout Medical City | Abu Dhabi | United Arab Emirates | 11001 | |
150 | Mediclinic Parkview Hospital | Dubai-UAE | United Arab Emirates | ||
151 | Royal Victoria Hospital | Belfast | United Kingdom | BT12 6BA | |
152 | University Hospital Coventry | Coventry | United Kingdom | CV2 2DX | |
153 | Raigmore Hospital; Highland Clin Rsrch Facility, Ctr For Health Sci | Inverness | United Kingdom | IV2 3JH | |
154 | Leeds General Infirmary | Leeds | United Kingdom | LS1 3EX | |
155 | Lincoln County Hospital | Lincoln | United Kingdom | LN2 5QY | |
156 | St George's Hospital | London | United Kingdom | SW17 ORE | |
157 | Luton General Hospital; Luton & Dunstable University Hospital, Neurology department | Luton | United Kingdom | LU4 0DZ | |
158 | James Cook Hospital | Middlesbrough | United Kingdom | TS4 3BW | |
159 | John Radcliffe Hospital | Oxford | United Kingdom | OX3 9DU | |
160 | Derriford Hospital | Plymouth | United Kingdom | PL6 8DH | |
161 | Royal Hallamshire Hospital; Neurology | Sheffield | United Kingdom | S10 2JF | |
162 | Royal Stoke University Hospital | Stoke-on-Trent | United Kingdom | ST4 6QG | |
163 | Sunderland Royal Hospital | Sunderland | United Kingdom | SR4 7TP | |
164 | Morriston Hospital; Cardiac Center | Swansea | United Kingdom | SA6 6NL | |
165 | Southmead Hospital | Westbury-on-Trym, Bristol | United Kingdom | BS10 5NB |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MN39889