O'HAND: A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04035005
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 208
• Arms: 2
• Anticipated Duration (Months): 103.8
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of ocrelizumab ( Ocrevus®) compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression. This study will consist of the following phases: screening, double-blind treatment, follow-up 1 (FU1), an optional open-label extension (OLE), follow-up 2 (FU2), and B-cell monitoring (BCM).

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis, Primary Progressive	Drug: Ocrelizumab; Drug: Placebo	Phase 3

Detailed Description

The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 120 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks. In the FU1 phase, all participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants who receive post-double progression ocrelizumab (PDP OCR) treatment, other immunomodulatory or immunosuppressive treatment(s) for MS, commercial ocrelizumab, or no treatment. The FU1 phase will run in parallel with the double-blind treatment phase until the primary analysis is performed. If the primary analysis is positive, an optional OLE phase is planned for eligible participants who either have remained in the double-blind treatment phase or are on PDP OCR treatment at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment. The follow-up 2 (FU2) phase will begin after the primary analysis is performed. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 and not on PDP OCR treatment at the time of primary analysis; participants who are ongoing in the double-blind treatment phase or receiving PDP OCR at the time of the primary analysis and do not enter the OLE phase; participants who complete or withdraw from the OLE phase. At the end of the FU2, all participants will move into B-cell monitoring (BCM) phase until the end of the study. This study will end when all participants who are not being treated with an alternative B-cell depleting therapy have repleted his or her B-cells.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis
• Actual Study Start Date: Aug 12, 2019
• Anticipated Primary Completion Date: Apr 1, 2025
• Anticipated Study Completion Date: Apr 4, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ocrelizumab Participants will receive ocrelizumab by IV infusion every 24 weeks.	Drug: Ocrelizumab; The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.; Other Names: Ocrevus
Placebo Comparator: Placebo Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks.	Drug: Placebo; The first dose of placebo will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.

Outcome Measures

Primary Outcome Measures

1. Time to Upper Limb Disability Progression Confirmed For at Least 12 Weeks [Baseline up to approximately 5.5 years]

   20% increase from baseline in Nine-Hole Peg Test (9-HPT) confirmed for at least 12 weeks.

Secondary Outcome Measures

1. Time to Upper Limb Disability Progression Confirmed For at Least 24 Weeks [Baseline up to approximately 5.5 years]

   20% increases from baseline in 9-HPT confirmed for at least 24 weeks.

2. Time to Disability Progression Confirmed For at Least 12 Weeks [Baseline up to approximately 5.5 years]

   Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.

3. Time to Disability Progression Confirmed For at Least 24 Weeks [Baseline up to approximately 5.5 years]

   Increase in EDSS Score is defined as an increase of >= 1.0 point from baseline EDSS score in participants with a baseline EDSS score <= 5.5 or an increase of >= 0.5 point in participants with a baseline EDSS score of > 5.5.

4. Percent Change in Total Volume of T2 Lesions on MRI [Baseline up to week 120]

5. Percent Change in Total Brain Volume on MRI Scans [Week 24 to Week 120]

6. Percentage of Participants with Adverse Events [Baseline up to 8.5 years]

7. Percentage of Participants With Serious Adverse Events [Baseline up to 8.5 years]

8. Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab [Baseline, Weeks 2, 12, 24, 48, 60, 72, and every 12 weeks till the end of the double-blind period and Weeks 0 and 48 of the OLE period]

9. Evaluation of Ocrelizumab Pharmacodynamics, as measured by B-Cell Levels in Blood [Baseline, Weeks 2, 24, 48, 72 and every 12 weeks till the end of the double-blind period and Weeks 0, 22, 46, 70 and 96 of the OLE period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• EDSS score at screening and baseline >= 3.0 to 8.0, inclusive

• Disease duration from the onset of MS symptoms relative to randomization date:

Less than 20 years in patients with an EDSS score at screening 7.0 - 8.0 Less than 15 years in patients with an EDSS at screening 5.5 - 6.5 Less than 10 years in patients with an EDSS at screening <= 5.0

• Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen: Elevated IgG index or one or more IgG oligoclonal bands detected by isoelectric focusing

• Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)

• Neurological stability for ≥ 30 days prior to baseline

• Ability to complete the 9-HPT within 240 seconds with each hand at screening and baseline

• Neurological stability for >/= 30 days prior to baseline

• Patients previously treated with immunosuppressants, immunomodulators, or other immunomodulatory therapies must undergo an appropriate washout period according to the local label of the immunosuppressant/immunomodulatory drug used

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.

• For female patients without reproductive potential: Women may be enrolled if surgically sterile (i.e hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile

Exclusion Criteria:

• History of relapsing-remitting or secondary progressive MS at screening

• Confirmed serious opportunistic infection including: active bacterial, viral, fungal, mycobacterial infection or other infection, including tuberculosis or atypical mycobacterial disease

• Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy (PML)

• Known active malignancy or are being actively monitored for recurrence of malignancy

• Immunocompromised state

• Receipt of a live-attenuated vaccine within 6 weeks prior to randomization

• Inability to complete an MRI or contraindication to Gd administration.

• Patients requiring symptomatic treatment of MS and/or physiotherapy who are not on a stable regimen. Patients must not initiate symptomatic treatment of MS or physiotherapy within 4 weeks of randomization.

• Contraindications to mandatory premedications for infusion-related reactions, including:

uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines

• Known presence of other neurologic disorders

• Pregnant or breastfeeding, or intending to become pregnant during the study and for 6 or 12 months after last infusion of the study drug

• Lack of peripheral venous access

• Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude patient from participating in the study

• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study

• History of alcohol or other drug abuse

• History of primary or secondary immunodeficiency

• Treatment with any investigational agent within 24 weeks prior to screening (Visit 1) or 5 half-lives of the investigational drug (whichever is longer), or treatment with any experimental procedure for MS

• Previous treatment with B-cell targeting therapies

• Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation

• Any previous history of transplantation or anti-rejection therapy

• Treatment with IV Ig or plasmapheresis within 12 weeks prior to randomization

• Systemic corticosteroid therapy within 4 weeks prior to screening

• Positive serum hCG measured at screening or positive urine β-hCG at baseline

• Positive screening tests for hepatitis B

• Any additional exclusionary criterion as per ocrelizumab (Ocrevus®) local label, if more stringent than the above

• Lack of MRI activity at screening/baseline if more than 650 patients without MRI activity have already been enrolled, as defined by T1 Gd+ lesion(s) and/or new and/or enlarged T2 lesion(s) in the screening, to ensure that at least 350 patients with MRI activity will be randomized

Eligibility Criteria for Open-Label Extension Phase:

• Completed the double-blind treatment phase of the trial or have received PDP OCR in the FU1 phase, and who, in the opinion of the investigator, may benefit from treatment with Ocrelizumab. Patients who withdrew from study treatment and received another disease-modifying therapy (DMT) or commercial ocrelizumab will not be allowed to enter in the OLE phase.

• Meet the re-treatment criteria for ocrelizumab

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods during the treatment period and for 6 or 12 months after the final dose of ocrelizumab. Adherence to local requirements, if more stringent, is required.

• For female patients without reproductive potential: Women may be enrolled if surgically sterile (i.e. hysterectomy, complete bilateral oophorectomy) or post-menopausal unless the patient is receiving a hormonal therapy for her menopause or if surgically sterile

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Neurological Associates Ltd	Phoenix	Arizona	United States	85006
2	Arcadia Neurology Center	Arcadia	California	United States	91006
3	Multiple Sclerosis Center of California	Newport Beach	California	United States	92663
4	Georgetown University Medical Center	Washington	District of Columbia	United States	20007
5	SFM Clinical Research, LLC	Boca Raton	Florida	United States	33487
6	MS and Neuromuscular Center of Excellence	Clearwater	Florida	United States	33761
7	Neurological Services of Orlando	Orlando	Florida	United States	32806
8	Vero Neurology	Vero Beach	Florida	United States	32960
9	Consultants in Neurology Ltd	Northbrook	Illinois	United States	60062
10	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
11	Michigan Neurology Associates P.C.	Clinton Township	Michigan	United States	48035
12	Henry Ford Hospital	Detroit	Michigan	United States	48202
13	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-0600
14	University of New Mexico	Albuquerque	New Mexico	United States	87131
15	Dent Neurological Institute	Amherst	New York	United States	14226
16	State University of New York at Buffalo; Department of Neurology	Buffalo	New York	United States	14203
17	Columbus Neuroscience	Columbus	Ohio	United States	43801
18	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
19	Albert Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
20	Premier Neurology	Greer	South Carolina	United States	29650
21	Vanderbilt MS Clinic	Nashville	Tennessee	United States	37215
22	Maxine Mesinger MS Clinic/Baylor College of Medicine; Neurology	Houston	Texas	United States	77030
23	Meridian Clinical Research	Norfolk	Virginia	United States	23502
24	Center for Neurological Disorders	Milwaukee	Wisconsin	United States	53215
25	Brain and Mind Research Institute	Camperdown	New South Wales	Australia	2050
26	John Hunter Hospital	New Lambton	New South Wales	Australia	2305
27	Austin Hospital	Heidelberg	Victoria	Australia	3084
28	Royal Melbourne Hospital	Parkville	Victoria	Australia	3050
29	Medizinische Universitat Graz	Graz		Austria	8036
30	Kepler Universitatsklinikum Linz	Linz		Austria	4021
31	Christian-Doppler-Klinik Salzburg	Salzburg		Austria	5020
32	Cliniques Universitaires St-Luc	Bruxelles		Belgium	1200
33	UZ Antwerpen	Edegem		Belgium	2650
34	CHU Tivoli	La Louvière		Belgium	7100
35	MS & Neurologisch Revalidatie Centrum	Overpelt		Belgium	3900
36	Military Medical Academy HBAT	Pleven		Bulgaria	5800
37	Multiprofile Hospital For Active Treatment Avis Medica	Pleven		Bulgaria	5800
38	Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD	Sofia		Bulgaria	1113
39	University of Alberta	Edmonton	Alberta	Canada	T6G 2G3
40	Vancouver Hospital Ubc	Vancouver	British Columbia	Canada	V6T 2B5
41	Health Sciences Centre Winnipeg	Winnipeg	Manitoba	Canada	R3A 1R9
42	Dalhousie Multiple Sclerosis Research Unit	Halifax	Nova Scotia	Canada	B3H 4K4
43	London Health Sciences Centre	London	Ontario	Canada	N6A 4L6
44	Ottawa Hospital	Ottawa	Ontario	Canada	K1H 8L6
45	University of Toronto	Toronto	Ontario	Canada	M5G 1Z6
46	Clinique Neuro Outaouais	Gatineau	Quebec	Canada	J8Y 1W2
47	Recherche Sepmus, Inc.	Greenfield Park	Quebec	Canada	J4V 2J2
48	Clinica Colsanitas S.A. sede Clinica Universitaria Colombia	Bogota		Colombia	111321
49	Sociedad de Cirugia de Bogota Hospital San Jose	Bogotá		Colombia	111411
50	Instituto Neurologico de Colombia INDEC	Medellin		Colombia
51	Clinical Hospital Centre Osijek	Osijek		Croatia	31000
52	General Hospital Varazdin	Varazdin		Croatia	42000
53	Clinical Hospital Sestre Milosrdnice	Zagreb		Croatia	10000
54	University Hospital Center Zagreb	Zagreb		Croatia	10000
55	Alexandria University Hospital; New University Hospitlal Building;Clinical Research Center CRC	Alexandria		Egypt	21500
56	Ain Shams University Hospital	Cairo		Egypt	11566
57	Sayed Galal University Hospital; Neurology Department	Cairo		Egypt	11865
58	CHU Amiens Hopital Sud; Neurologie	Amiens Cedex1		France	80054
59	Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin	Bordeaux		France	33076
60	Hopital Pierre Wertheimer - Hopital Neurologique	Bron		France	69677
61	Centre Hospitalier Universitaire de Clermont Ferrand	Clermont-ferrand		France	63000
62	Centre Hospitalier de Colmar - Hopital Louis Pasteur; Service de Neurologie	Colmar		France	68024
63	Hopital Saint Vincent de Paul - GHICL Lille - Parent	Lille		France	59020
64	Hopitaux de La Timone	Marseille		France	13385
65	CHU Gui de Chauliac	Montpellier		France	34000
66	CHRU Nancy	Nancy		France	54035
67	Hopital Guillaume Et Rene Laennec	Nantes		France	44805
68	CHU de Nimes - Hopital Universitaire Caremeau	Nimes		France	30900
69	Groupe Hospitalier Paris Saint Joseph	Paris		France	75014
70	Hopital Civil	Strasbourg		France	67091
71	Pineo Medical Ecosystem LTD	Tbilisi		Georgia	0114
72	Tbilisi State Medical University	Tbilisi		Georgia	0141
73	Khechinashvili University Hospital	Tbilisi		Georgia	179
74	Medizinische Hochschule Hannover	Hannover		Germany	30625
75	Bacs-Kiskun Megyei Korhaz	Kecskemet		Hungary	6000
76	Szent Borbala Korhaz	Tatabánya		Hungary	2800
77	Saint Vincent's University Hospital	Dublin		Ireland	Dublin 4
78	AOU dell'Università degli Studi della Campania Luigi Vanvitelli	Napoli	Campania	Italy
79	Fondazione PTV Policlinico Tor Vergata	Rome	Lazio	Italy	00133
80	Azienda Ospedaliera Sant'andrea	Rome	Lazio	Italy	00189
81	Ospedale Policlinico San Martino	Genova	Liguria	Italy	16132
82	Ospedale San Raffaele S.r.l. - PPDS	Milano	Lombardia	Italy	20132
83	ASST degli Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari	Montichiari	Lombardia	Italy	25018
84	ASST di Pavia - Fondazione Istituto Neurologico Mondino IRCCS	Pavia	Lombardia	Italy	27100
85	Azienda Sanitaria Ospedaliera S Luigi Gonzaga	Orbassano	Piemonte	Italy	10043
86	Fondazione Istituto G. Giglio di Cefalu	Cefalù	Sicilia	Italy	90015
87	Azienda Ospedaliera di Padova; Clinica Neurologica	Padova	Veneto	Italy	35128
88	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco	Mexico	44280
89	Centro de Diagnostico Neurofisiologico S.C	Mexico City	Mexico CITY (federal District)	Mexico	01600
90	Unidad de Investigacion en Salud de Chihuahua	Mexico City	Mexico CITY (federal District)	Mexico	14390
91	Neurociencias Estudios Clinicos S.C.	Culiacán	Sinaloa	Mexico	80020
92	Scientia Investigacion Clinica S.C.	Chihuahua		Mexico	31203
93	Hospital Angeles Chihuahua	Chihuahua		Mexico	31238
94	Grupo Medico Camino	DF		Mexico	03310
95	Instituto de Investigaciones Aplicadas a la Neurociencia A.C.	Durango		Mexico	34000
96	Clinical Associates in Research Therapeutics of Americas-Mexico CARTA-MEX	Monterrey		Mexico	64050
97	Clinical Research Institute	Tlalnepantla		Mexico	54055
98	Christchurch Hospital	Christchurch		New Zealand	8011
99	Dunedin Hospital	Dunedin		New Zealand
100	Waikato Hospital; Neurology	Hamilton		New Zealand	3240
101	Wellington Hospital; Department of Neurology	Wellington		New Zealand	6021
102	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok		Poland	15-276
103	Neurocentrum Bydgoszcz sp z o.o	Bydgoszcz		Poland	85-796
104	COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny	Gdansk		Poland	80-803
105	M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM	Katowice		Poland	40-571
106	RESMEDICA Spolka z o.o.	Kielce		Poland	25-726
107	SP ZOZ Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Kliniki Neurologii	Kraków		Poland	31-503
108	Centrum Neurologii Krzysztof Selmaj	Lodz		Poland	90-324
109	Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak	Lublin		Poland	20-605
110	Wojewodzki Szpital Specjalistyczny	Olsztyn		Poland	10-561
111	Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa	Poznań		Poland	60-848
112	Wojewódzki Szpital Specjalistyczny Nr 3	Rybnik		Poland	44-200
113	Centrum Medyczne "MEDYK"	Rzeszow		Poland	35-055
114	EUROMEDIS Sp z o o	Szczecin		Poland	70-111
115	Centrum Medyczne NeuroProtect	Warszawa		Poland	01-684
116	Instytut Psychiatrii i Neurologii II Klinika Neurologiczna	Warszawa		Poland	02-957
117	Miedzyleski Szpital Specjalistyczny w Warszawie	Warszawa		Poland	04-749
118	EMC Instytut Medyczny S.A.	Wrocław		Poland	50-220
119	SPSK Nr 1 Im Prof S Szyszko Slaskiego Uniwersytetu Medcznego	Zabrze		Poland	41-800
120	Hospital de Braga	Braga		Portugal	4710-243
121	Hospital Beatriz Angelo	Loures		Portugal	2674-514
122	Centro Hospitalar do Porto - Hospital de Santo António	Porto		Portugal	4099-001
123	Campus Neurologico Senior	Torres Vedras		Portugal	2560-280
124	Colentina Clinical Hospital	Bucharest		Romania	020125
125	Emergency University Hospital	Bucharest		Romania	050098
126	SC Clubul Sanatatii SRL	Campulung		Romania	115100
127	County Hospital Caracal	Caracal		Romania	235200
128	Cai Ferate Clinical Hospital	Constanţa		Romania	900123
129	Spitalul Municipal Dr.Alexandru Simionescu Hunedoara	Hunedoara		Romania	331057
130	Targu Mures Clinical Emergency County Hospital	Targu Mures		Romania	540100
131	State Healthcare Institution Territorial Clinical Hospital	Barnaul	Altaj	Russian Federation	656024
132	Kuvatov Republican Clinical Hospital	UFA	Baskortostan	Russian Federation	450005
133	Research Center of Neurology of RAMS	Moscow	Moskovskaja Oblast	Russian Federation	125367
134	City Clinical Hospital #24	Moscow	Moskovskaja Oblast	Russian Federation	127015
135	Moscow Regional Research Clinical Institute Na Mfvladimirskiy	Moscow	Moskovskaja Oblast	Russian Federation	129110
136	City Out Patient Clinic For Rehabilitation Treatment #7	Moskva	Moskovskaja Oblast	Russian Federation	105005
137	City Clinical Hospital #15 n.a. N.F. Filatov	Moskva	Moskovskaja Oblast	Russian Federation	111539
138	Neftyanik Medical and Sanitary Unit	Tumen	Moskovskaja Oblast	Russian Federation	625000
139	City Clinical Hospital #12	Nizhny Novgorod	Niznij Novgorod	Russian Federation	603003
140	Nizhniy Novgorod City Hospital #33	Nizhny Novgorod	Niznij Novgorod	Russian Federation	603005
141	Nizhegorodskaya Regional Clinical Hospital n.a. Semashko	Nizhny Novgorod	Niznij Novgorod	Russian Federation	603126
142	City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31	Sankt-peterburg	Sankt Petersburg	Russian Federation	197110
143	City Hospital #40 of Kurortniy Administrative District	St. Petersburg	Sankt Petersburg	Russian Federation	197706
144	Yaroslavl Clinical Hospital #8	Yaroslavl	Sankt Petersburg	Russian Federation	150030
145	City Clinical Hospital #4	Saransk	Saratov	Russian Federation	430032
146	Republican Clinical Hospital For Rehabilitation Treatment	Kazan	Tatarstan	Russian Federation	420021
147	Ulyanovsk Regional Clinical Hospital	Ulyanovsk	Uljanovsk	Russian Federation	432063
148	Belgorod Regional Clinical Hospital	Belgorod		Russian Federation	308007
149	Sverdlovsk Regional Clinical Hospital 1	Ekaterinburg		Russian Federation	620102
150	Kemerovo Regional Clinical Hospital	Kemerovo		Russian Federation	650066
151	Kirov State Medical Academy	Kirov		Russian Federation	610027
152	Krasnoyarsk State Medical Academy	Krasnoyarsk		Russian Federation	660022
153	SBHI of Nizhny Novgorod region City Clinical Hospital #3; neurology department	Nizniy Novgorod		Russian Federation	603155
154	FSBIH Siberian Regional Medical Centre of FMBA of Russia	Novosibirsk		Russian Federation	630007
155	Perm SMA n.a. academ. E.A. Vagner	Perm		Russian Federation	614990
156	Samara Regional Clinical Hospital named after V.D. Seredavina	Samara		Russian Federation	443095
157	Siberian State Medical University of Roszdrav	Tomsk		Russian Federation	634050
158	Regional State Budget Institution of Healthcare Tver Regional Clinical Hospital	Tver		Russian Federation
159	Clinical Center of Serbia	Belgrade		Serbia	11000
160	Military Medical Academy	Belgrade		Serbia	11040
161	Clinical Center Kragujevac	Kragujevac		Serbia	34000
162	Clinical Center Nis	NIS		Serbia	18000
163	Clinical Centre of Vojvodina	Nova Sad		Serbia	21000
164	General Hospital Uzice	Uzice		Serbia	31000
165	Clinical Hospital Centre Zemun	Zemun		Serbia	11080
166	Hospital Universitario Puerta de Hierro - Majadahonda	Majadahonda	Madrid	Spain	28220
167	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Madrid	Spain	28223
168	Complejo Hospitalario Universitario de Vigo	Vigo	Pontevedra	Spain	36204
169	Hospital Universitario Virgen Macarena	Seville	Sevilla	Spain	41071
170	Hospital Universitario Cruces	Barakaldo	Vizcaya	Spain	48903
171	Hospital Universitario Vall d'Hebron - PPDS	Barcelona		Spain	08035
172	Hospital Clinic de Barcelona	Barcelona		Spain	08036
173	Hospital General de Castellon	Castellon		Spain	12004
174	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
175	Hospital Universitario HM Sanchinarro-CIOCC	Madrid		Spain	28050
176	Hospital Regional Universitario de Malaga - Hospital General	Malaga		Spain	29010
177	Hospital Universitario Virgen de La Arrixaca	Murcia		Spain	30120
178	Complejo Asistencial Universitario de Salamanca - H. Clinico	Salamanca		Spain	37007
179	Hospital Universitari i Politecnic La Fe de Valencia	Valencia		Spain	46026
180	Medical Center Dopomoga Plus	Kyiv	Chernihiv Governorate	Ukraine	02123
181	Medical Centre of PE First Private Clinic	Zhytomir	Crimean Regional Governmenta	Ukraine	10008
182	Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council	Zaporizhzhia	Katerynoslav Governorate	Ukraine	69600
183	Zaporizhia City Multispecialty Clinical Hospital #9	Zaporizhzhye	Katerynoslav Governorate	Ukraine	69063
184	Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital	Kharkiv	Kharkiv Governorate	Ukraine	61058
185	Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital	Lviv	Kharkiv Governorate	Ukraine	79010
186	LLC Medical Center Family Medicine Clinic	Dnipro	Kherson Governorate	Ukraine	49600
187	Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh	Kherson	Kherson Governorate	Ukraine	73000
188	Medical Center of LLC MRT Elit	Kropyvnytsiy	Kherson Governorate	Ukraine	25005
189	ME Dnipropetrovsk Regional Clinical Hospital n.a. I.I Mechnykov Dnipropetrovsk Regional Council	Dnipro	KIEV Governorate	Ukraine	49005
190	Medical Center of LLC Medical Clinic Blagomed	Kyiv	KIEV Governorate	Ukraine	01001
191	Medical Clinical Research Center of Medical Center LLC Health Clinic	Vinnytsia	Podolia Governorate	Ukraine	21009
192	Municipal Institution Vinnytsia Regional Psychoneurological Hospital n.a. O.I. Yushchenko	Vinnytsya	Podolia Governorate	Ukraine	21005
193	Regional Clinical Hospital	Ivano-Frankivsk		Ukraine	76018
194	Kyiv City Clinical Hospital #4	Kyiv		Ukraine	03110
195	Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital	Kyiv		Ukraine	04107
196	Volyn Regional Clinical Hospital	Lutsk		Ukraine	43024
197	University Hospital of Wales	Cardiff		United Kingdom	CF14 4XW
198	Queen Elizabeth University Hospital - PPDS	Glasgow		United Kingdom	G51 4TF
199	Raigmore Hospital - PPDS	Inverness		United Kingdom	IV2 3UJ
200	Walton Centre For Neurology and Neurosurgery	Liverpool		United Kingdom	L9 7LJ
201	The Royal London Hospital	London		United Kingdom	E1 1BB
202	The National Hospital for Neurology & Neurosurgery	London		United Kingdom	WC1N 3BG
203	University of Nottingham	Nottingham		United Kingdom	NG7 2UH
204	Peninsula College of Medicine and Dentistry	Plymouth		United Kingdom	PL6 8BX
205	Salford Royal Hospital	Salford		United Kingdom	M6 8HD
206	Royal Hallamshire Hospital	Sheffield		United Kingdom	S10 2JF
207	University Hospital Southampton NHS Foundation Trust	Southhampton		United Kingdom	SO16 6YD
208	Morriston Hospital	Swansea		United Kingdom	SA6 6NL

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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT04035005
• Other Study ID Numbers: WA40404
• First Posted: Jul 29, 2019
• Last Update Posted: Feb 21, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Ocrelizumab

Study Results

No Results Posted as of Feb 21, 2021