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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001511-73 | EudraCT Number | ||
| 2023-505980-36-00 | EU Trial (CTIS) Number |
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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 will consist of the following phases: screening, double-blind treatment, an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), and follow-up 2 (FU2).
The screening phase will last up to 24 weeks. In the double-blind treatment phase, participants will undergo at least 144 weeks of study treatment. Study drug (ocrelizumab or placebo) will be administered every 24 weeks. All participants who discontinue prematurely from the double-blind treatment phase will enter the FU1 phase, including participants receiving 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 for 144 weeks or until the primary analysis is performed, whichever occurs first. An optional OLE phase is planned for eligible participants who either have either completed 144 weeks of the double-blind treatment phase or are ongoing in the double-blind treatment phase at the time of the primary analysis and, in the opinion of the investigator, could benefit from ocrelizumab treatment. The following participants will move into the FU2 phase: participants who are ongoing in the FU1 at 144 weeks from randomization or at the time of the primary analysis; participants who have either completed 144 weeks of the double-blind treatment phase or are ongoing in the double-blind treatment phase at the time of the primary analysis and will not enter the OLE phase; participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | Participants will receive ocrelizumab by intravenous (IV) infusion every 24 weeks. |
|
| Placebo | Placebo Comparator | Participants will receive placebo matched to ocrelizumab by IV infusion every 24 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | The first dose of ocrelizumab will be administered as two 300 milligrams (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 on if the previous dose was administered in one or two infusion, should be maintained between each infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS | Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (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 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems & ambulation, that ranges in 0.5-point steps from 0 [normal] to 10.0 [death]. 9-HPT is a quantitative measure of arm & hand function, where participants placed & removed pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | Up to approximately 243 weeks |
| Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set | Time to onset of cCDP12 was defined as the time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in 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 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems & ambulation, that ranges in 0.5-point steps from 0 [normal] to 10.0 [death]. 9-HPT is a quantitative measure of arm & hand function, where participants placed & removed pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | Up to approximately 243 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 12-week CDP in 9-HPT | 12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. |
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Inclusion Criteria:
Less than 20 years in participants with an EDSS score at screening 7.0 - 8.0 Less than 15 years in participants with an EDSS at screening 5.5 - 6.5 Less than 10 years in participants with an EDSS at screening <= 5.0
Exclusion Criteria:
uncontrolled psychosis for corticosteroids and closed-angle glaucoma for antihistamines
Eligibility Criteria for OLE Phase:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| MS and Neuromuscular Center of Excellence |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208561 | Derived | Giovannoni G, Airas L, Bove R, Cutter GR, Czarnecki M, Drulovic J, Hobart J, Kuhle J, Montalban X, Selmaj KW, Tur C, Wolinsky JS, Baldinotti A, Bonati U, Craveiro L, Giacobino C, Manfrini M, Schneble HM, Stevenson P, Wang Q, Yang K, Oh J; ORATORIO-HAND study group. Efficacy and safety of ocrelizumab in primary progressive multiple sclerosis, including older patients and those with more advanced disease (ORATORIO-HAND): a multicentre, double-blind, randomised, placebo-controlled, phase 3b study. Lancet. 2026 May 30;407(10544):2195-2207. doi: 10.1016/S0140-6736(26)00617-3. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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1 participant randomized to the placebo group received a single dose of ocrelizumab & was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment & was not included in safety analysis. The study is still ongoing.
A total of 1013 participants with primary progressive multiple sclerosis (PPMS) took part in the study at 148 investigative sites across 23 countries. Participants were randomized in a 1:1 ratio to receive double-blinded treatment (DBT) with either ocrelizumab or placebo followed by an optional post-double-progression ocrelizumab (PDP OCR) treatment, follow-up 1 (FU1), an optional open-label extension (OLE), & follow-up 2 (FU2).
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocrelizumab | Participants received the first dose of ocrelizumab as two 300 milligrams (mg) intravenous (IV) infusions, administered 14 days apart. Thereafter, participants received ocrelizumab 600 mg as a single IV infusion every 24 weeks (Q24W) for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a double-progression event (DPE) during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| DBT |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 4, 2024 | Jan 6, 2026 |
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|
| Placebo | Drug | The first dose of placebo will be administered as two IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending on if the previous dose was administered in one or two infusions, maintained between each infusion. |
|
| Up to approximately 243 weeks |
| Time to 12-week CDP in EDSS | 12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of <5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel & bladder, & cerebral [or mental]) that are rated & then scored as a functional system scores (FSS), & ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, & ambulation score that is rated from 0 to 16. These ratings along with observations & assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps. | Up to approximately 243 weeks |
| Time to 24-week CDP in 9-HPT | 24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | Up to approximately 243 weeks |
| Time to 24-week CDP in EDSS | 24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of <5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel & bladder, & cerebral [or mental]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps. | Up to approximately 243 weeks |
| Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions | Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change. | Up to approximately 120 weeks |
| Annual Rate of Percent Change From Week 24 in Total Brain Volume | Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change. | From Week 24 up to approximately 120 weeks |
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment. | From initiation of study drug up to approximately 10.5 years |
| Serum Concentration of Ocrelizumab | Up to approximately 10.5 years |
| B-cell Levels in Blood | Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
| Change From Baseline in B-cell Levels | Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
| Percentage of Participants With B-cell Counts ≤5 Cells/μL | Percentages have been rounded off. | Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
| Percentage of Participants With B-cell Counts ≤10 Cells/μL | Percentages have been rounded off. | Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
| Number of Participants With ADAs to Ocrelizumab | Prevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result. | Baseline up to approximately 10.5 years |
| Clearwater |
| Florida |
| 33761 |
| United States |
| Neurological Services of Orlando | Orlando | Florida | 32806 | United States |
| Vero Neurology | Vero Beach | Florida | 32960 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company | Columbus | Ohio | 43235-5422 | United States |
| Columbus Neuroscience | Westerville | Ohio | 43082-6910 | United States |
| Albert Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| Brain and Mind Research Institute | Camperdown | New South Wales | 2050 | Australia |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| UZ Antwerpen | Edegem | Antwerpen | 2650 | Belgium |
| Cliniques Universitaires St-Luc | Brussels | 1200 | Belgium |
| MS & Neurologisch Revalidatie Centrum | Overpelt | 3900 | Belgium |
| Military Medical Academy HBAT | Pleven | 5800 | Bulgaria |
| Multiprofile Hospital For Active Treatment Avis Medica | Pleven | 5800 | Bulgaria |
| Multiprofile Hospital for Active Treatment of Neurology and Psychiatry Sv. Naum EAD | Sofia | 1113 | Bulgaria |
| University of Alberta | Edmonton | Alberta | T6G 2G3 | Canada |
| Dalhousie Multiple Sclerosis Research Unit | Halifax | Nova Scotia | B3H 4K4 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| Recherche Sepmus Inc. | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Instituto Neurologico de Colombia INDEC | Medellín | Antioquia | 50012 | Colombia |
| Clinica Colsanitas S.A. sede Clinica Universitaria Colombia | Bogotá | 111321 | Colombia |
| General Hospital Varazdin | Varaždin | 42000 | Croatia |
| Clinical Hospital Sestre Milosrdnice | Zagreb | 10000 | Croatia |
| University Hospital Center Zagreb | Zagreb | 10000 | Croatia |
| CHU de Bordeaux - Hôpital Pellegrin | Bordeaux | 33076 | France |
| Centre Hospitalier Universitaire de Clermont Ferrand | Clermont-Ferrand | 63003 | France |
| CHRU Nancy | Nancy | 54035 | France |
| Hopital Guillaume Et Rene Laennec | Nantes | 44805 | France |
| CHU de Nimes - Hopital Universitaire Caremeau | Nîmes | 30900 | France |
| Hopital Civil | Strasbourg | 67098 | France |
| Pineo Medical Ecosystem LTD | Tbilisi | 0114 | Georgia |
| The First University Clinic of Tbilisi State Medical University | Tbilisi | 0141 | Georgia |
| Khechinashvili University Hospital | Tbilisi | 179 | Georgia |
| AOU dell Universita degli Studi della Campania Luigi Vanvitelli Piazza Luigi Miraglia 2 | Naples | Campania | 80138 | Italy |
| Fondazione PTV Policlinico Tor Vergata | Rome | Lazio | 00133 | Italy |
| Azienda Ospedaliera Sant'andrea | Rome | Lazio | 00189 | Italy |
| IRCCS AOM Azienda Ospedaliera Metropolitana | Genoa | Liguria | 16132 | Italy |
| Ospedale San Raffaele S.r.l. - PPDS | Milan | Lombardy | 20132 | Italy |
| Fondazione Istituto Neurologico Mondino IRCCS | Pavia | Lombardy | 27100 | Italy |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | Orbassano | Piedmont | 10043 | Italy |
| Fondazione Istituto G. Giglio di Cefalu | Cefalù | Sicily | 90015 | Italy |
| Hotel Dieu de France | Achrafieh Beirut | 000000 | Lebanon |
| Saint George University Medical Hospital | El Achrafiyé | DUMMY_VALUE | Lebanon |
| Grupo Medico Camino | Mexico City | Mexico CITY (federal District) | 03310 | Mexico |
| Neurociencias Estudios Clinicos S.C. | Culiacán | Sinaloa | 80020 | Mexico |
| Hospital Angeles Chihuahua | Chihuahua City | 31238 | Mexico |
| Unidad de Investigacion en Salud de Chihuahua | Mexico City | 14050 | Mexico |
| Clinical Research Institute | Tlalnepantla | 54055 | Mexico |
| CHU Mohammed VI | Marrakesh | 40080 | Morocco |
| Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites | Rabat | 10100 | Morocco |
| New Zealand Clinical Research - Christchurch | Christchurch | 8011 | New Zealand |
| Dunedin Hospital | Dunedin | New Zealand |
| Neurocentrum Bydgoszcz sp z o.o | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-796 | Poland |
| Przychodnia EuroMediCare | Wroclaw | Lower Silesian Voivodeship | 50-220 | Poland |
| Rejdak Konrad Indywidualna Praktyka Lekarska dr hab. Konrad Rejdak | Lublin | Lublin Voivodeship | 20-410 | Poland |
| Centrum Medyczne Medyk | Rzeszów | Podkarpackie Voivodeship | 35-055 | Poland |
| SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 | Rybnik | Silesian Voivodeship | 44-200 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku Marii Sklodowskiej Curie 24a | Bia?ystok | 15-276 | Poland |
| Copernicus Podmiot Leczniczy Sp z o o | Gda?sk | 80-803 | Poland |
| Mazowieckie Centrum Badan Klinicznych | Grodzisk Mazowiecki | 05-825 | Poland |
| MA-LEK Clinical Sp. Z o.o. | Katowice | 40-571 | Poland |
| Novo-Med Zielinski i wsp SpJ | Katowice | 40-584 | Poland |
| NEURO-MEDIC Sp. z o. o. | Katowice | 40-686 | Poland |
| Specjalistyczna Praktyka Lekarska Dr n.med. Stanislaw Ochudlo | Katowice | 40-752 | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | 31-503 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | 90-324 | Poland |
| Galen Clinic | Lublin | 20-064 | Poland |
| Wojewodzki Szpital Specjalistyczny | Olsztyn | 10-561 | Poland |
| Med-Polonia Sp. z o.o. | Poznan | 60-693 | Poland |
| EUROMEDIS Sp z o o | Szczecin | 70-215 | Poland |
| Centrum Medyczne NeuroProtect Zablocinska 10 | Warsaw | 01-684 | Poland |
| RESMEDICA Spolka z o.o. | Kielce | Świętokrzyskie Voivodeship | 25-726 | Poland |
| ULS de Loures-Odivelas, EPE - Hospital de Loures | Loures | Lisbon District | 2674-514 | Portugal |
| Hospital Garcia de Orta | Almada | 2805-267 | Portugal |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Hospital de Santo Antonio | Porto | 4099-001 | Portugal |
| Campus Neurologico Senior | Torres Vedras | 2560-280 | Portugal |
| Spitalul Judetean de Urgenta Deva | Deva | Hunedoara County | 330084 | Romania |
| SC Clubul Sanatatii SRL | Campulung Muscel | 115100 | Romania |
| Cai Ferate Clinical Hospital | Constanța | 900123 | Romania |
| Targu Mures Clinical Emergency County Hospital | Târgu Mure? | 540136 | Romania |
| Krasnoyarsk State Medical Academy | Krasnoyarsk | Krasnoyarsk Krai | 660022 | Russia |
| City Clinical Hospital a n Buyanov V M | Moscow | Moscow Oblast | 115516 | Russia |
| City Clinical Hospital #24 | Moscow | Moscow Oblast | 127015 | Russia |
| Moscow Regional Research Clinical Institute Na Mfvladimirskiy | Moscow | Moscow Oblast | 129110 | Russia |
| Research Center of Neurology of RAMS | Moskva | Moscow Oblast | 125367 | Russia |
| Neftyanik Medical and Sanitary Unit | Tumen | Moscow Oblast | 625000 | Russia |
| Nizhegorodskaya Regional Clinical Hospital n.a. Semashko | Nizhny Novgorod | Niznij Novgorod | 603126 | Russia |
| MEDIS Limited Liability Company | Nizhny Novgorod | Niznij Novgorod | 603137 | Russia |
| SBHI of Nizhny Novgorod region City Clinical Hospital #3 | Nizhny Novgorod | Niznij Novgorod | 603155 | Russia |
| National Center of Socially Significant Diseases | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| City Hospital #40 of Kurortniy Administrative District | Saint Petersburg | Sankt-Peterburg | 197706 | Russia |
| City Clinical Hospital #4 | Saransk | Saratov Oblast | 430032 | Russia |
| Sverdlovsk Regional Clinical Hospital 1 | Yekaterinburg | Sverdlovsk Oblast | 620102 | Russia |
| Vertebronevrologiya LLC | Kazan' | Tatarstan Republic | 420043 | Russia |
| Ulyanovsk Regional Clinical Hospital | Ulyanovsk | Ulyanovsk Oblast | 432063 | Russia |
| Belyayev Clinical Hospital of the Kuzbass | Kemerovo | 650066 | Russia |
| Kirov State Medical Academy | Kirov | 610027 | Russia |
| FSBIH Siberian Regional Medical Centre of FMBA of Russia | Novosibirsk | 630007 | Russia |
| Perm Regional Clinical Hospital of Znak Pocheta Medal | Perm | 614990 | Russia |
| Siberian State Medical University of Roszdrav | Tomsk | 634050 | Russia |
| Military Medical Academy | Belgrade | 11000 | Serbia |
| University Clinical Center of Serbia -PPDS | Belgrade | 11000 | Serbia |
| Clinical Hospital Centre Zemun | Belgrade | 11080 | Serbia |
| University Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Clinical Center Nis | Niš | 18000 | Serbia |
| Clinical Centre of Vojvodina | Nova Sad | 21000 | Serbia |
| General Hospital Uzice | Užice | 31000 | Serbia |
| Hospital Universitario Quironsalud Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Universitario Virgen de La Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Complejo Hospitalario Universitario de Vigo | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic de Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Puerta de Hierro - Majadahonda | Madrid | 28222 | Spain |
| Complejo Asistencial Universitario de Salamanca ? H. Clinico | Salamanca | 37007 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Universitari i Politecnic La Fe de Valencia | Valencia | 46026 | Spain |
| Hopital Razi | LA Mannouba | 2010 | Tunisia |
| Fattouma Bourguiba University Hospital | Monastir | 5000 | Tunisia |
| Hospital Habib Bourguiba | Sfax | 3029 | Tunisia |
| Military Hospital of Tunis | Tunis | 1008 | Tunisia |
| Treatment and diagnostic Center Neuro Global of LLC Neuro Global | Krykhivtsi | Ivano-Frankivsk Oblast | 76493 | Ukraine |
| Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital | Lviv | Kharkiv Governorate | 79010 | Ukraine |
| Municipal Non-profit Enterprise Kherson City Clinical Hospital named after Ye.Ye. Karabelesh | Kherson | Kherson Governorate | 73000 | Ukraine |
| Treatment and Diagnostic Center of LLC MRT Elit | Kropyvnytskyi | KIEV Governorate | 25005 | Ukraine |
| Medical Centre of PE First Private Clinic | Kyiv | KIEV Governorate | 03037 | Ukraine |
| Kyiv City Clinical Hospital #4 | Kyiv | KIEV Governorate | 03110 | Ukraine |
| Communal Non-Commercial Enterprise Clinical Hospital #15 of the Podilskyi District ofthe Kyiv City | Kyiv | KIEV Governorate | 04070 | Ukraine |
| Municipal NPE Regional Clinical Center of Neurosurgery and Neurology of Transcarpathian RC | Uzhhorod | KIEV Governorate | 88018 | Ukraine |
| Medical Center Artes Medicum LLC | Kyiv | Kyiv Oblast | 02002 | Ukraine |
| Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital | Lviv | Lviv Oblast | 79010 | Ukraine |
| Medical Center Salutem | Vinnytsia | Podolia Governorate | 21009 | Ukraine |
| LLC Medical Center Health Clinic | Vinnytsia | Volhynian Governorate | 21009 | Ukraine |
| LLC Medical Center Unimed | Zaporizhzhia | Zaporizhzhia Oblast | 69000 | Ukraine |
| University hospital of Dnipro State Medical University | Dnipro | 49089 | Ukraine |
| LLC Medical Center Family Medicine Clinic | Dnipro | 49600 | Ukraine |
| Communal Non-commercial Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | 61022 | Ukraine |
| Medical Center of LLC Medical Center Dopomoga Plus | Kyiv | 02000 | Ukraine |
| Private Enterprise Clinic Medicom | Kyiv | 04219 | Ukraine |
| Volyn Regional Clinical Hospital | Lutsk | 43005 | Ukraine |
| LLC Medical Center INET 09 | Zaporizhzhia | 69035 | Ukraine |
| Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council | Zaporizhzhia | 69600 | Ukraine |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Queen Elizabeth University Hospital - PPDS | Glasgow | G51 4TF | United Kingdom |
| Raigmore Hospital - PPDS | Inverness | IV2 3JH | United Kingdom |
| The Royal London Hospital | London | E1 1BB | United Kingdom |
| The National Hospital for Neurology & Neurosurgery | London, GT LON | WC1N 3BG | United Kingdom |
| University of Nottingham | Nottingham | NG7 2UH | United Kingdom |
| Peninsula College of Medicine and Dentistry | Plymouth | PL6 8BX | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | S10 2JF | United Kingdom |
| Morriston Hospital | Swansea | SA6 6NL | United Kingdom |
| FG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
| Safety Analysis Set (SAS) | SAS included all participants who received at least one infusion (partial or complete) of study drug. |
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| COMPLETED |
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| NOT COMPLETED |
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| PDP OCR Treatment Phase |
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| FU1 Phase |
|
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| OCR OLE Phase |
|
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| FU2 Phase |
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Full analysis set (FAS) included all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocrelizumab | Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
| BG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) in FAS | Time to onset of cCDP12=time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-hole Peg Test (9-HPT) confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in Expanded Disability Status Scale (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 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems & ambulation, that ranges in 0.5-point steps from 0 [normal] to 10.0 [death]. 9-HPT is a quantitative measure of arm & hand function, where participants placed & removed pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 243 weeks |
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| Primary | Time to Onset of cCDP12 in Magnetic Resonance Imaging (MRI) Activity Analysis Set | Time to onset of cCDP12 was defined as the time from randomization to the first occurrence of at least one of the following progression events: 1) 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks; 2) increase of ≥ 1.0 point from baseline in 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 that is confirmed for at least 12 weeks. EDSS disability scale is based on a standard neurological examination, incorporating functional systems & ambulation, that ranges in 0.5-point steps from 0 [normal] to 10.0 [death]. 9-HPT is a quantitative measure of arm & hand function, where participants placed & removed pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the total time (in seconds) required was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | MRI activity analysis set included all randomized participants with MRI activity, defined as the presence of T1 gadolinium-enhanced (Gd+) lesion(s) at baseline and/or new and/or enlarging T2 lesion(s) as detected by MRI scans during the screening phase. Participants were grouped according to the treatment assigned at randomization. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 243 weeks |
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| Secondary | Time to 12-week CDP in 9-HPT | 12-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the total time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 243 weeks |
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| Secondary | Time to 12-week CDP in EDSS | 12-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of <5.5 that is confirmed for at least 12 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel & bladder, & cerebral [or mental]) that are rated & then scored as a functional system scores (FSS), & ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0-5/6, & ambulation score that is rated from 0 to 16. These ratings along with observations & assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 243 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 24-week CDP in 9-HPT | 24-week CDP in 9-HPT was defined as a 20% worsening from baseline in 9-HPT confirmed for at least 24 weeks. 9-HPT is a quantitative measure of upper extremity (arm and hand) function. The test device consists of a container containing nine pegs and a wood or plastic block containing nine empty holes. Participants were required to pick up each of the 9 pegs one at a time and place them in the 9 holes. Once all the pegs were in the holes, the participants then removed them as quickly as possible. Both dominant and non-dominant hands were tested twice, and the amount of time (in seconds) to complete the task was recorded. The longer it took to complete the test, the higher the scores, indicating deterioration. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 243 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to 24-week CDP in EDSS | 24-week CDP in EDSS=an increase of ≥1.0 point from baseline EDSS score in participants with a baseline EDSS score of ≤5.5 or an increase of ≥0.5 points in participants with a baseline EDSS score of <5.5 that is confirmed for at least 24 weeks after initial documentation of the progression. EDSS was used to measure changes in the disability level of participants with MS over time. EDSS is based on a standard neurological examination, incorporating functional systems (visual, brainstem, pyramidal, cerebellar, sensory, bowel & bladder, & cerebral [or mental]) that are rated and then scored as a FSS, and ambulation, which is scored as ambulation score. Each FSS is an ordinal clinical rating scale where score ranges from 0 to 5 or 6, and ambulation score that is rated from 0 to 16. These ratings along with observations and assistive devices were then used to determine the total EDSS score. The total EDSS score ranges from 0 (normal) to 10.0 (death) in 0.5-point steps. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 243 weeks |
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| Secondary | Annual Rate of Change From Baseline in Radius of Total Volume of T2 Lesions | Volume of T2 lesions was measured using MRI scans. Mean difference in annual rate of change from baseline in radius of total volume of T2 lesions between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS disease-modifying treatment (DMT) or commercial ocrelizumab occurred, is reported. Random Coefficient Regression (RCRM) Model was used to estimate annual rate of change. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | 95% Confidence Interval | centimeter (cm) per year | Up to approximately 120 weeks |
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| Secondary | Annual Rate of Percent Change From Week 24 in Total Brain Volume | Brain volume was measured using MRI scans. Mean difference in annual rate of percent change from Week 24 in total brain volume between the ocrelizumab and placebo arms in participants with PPMS, including participants later in their disease course, where no treatment discontinuation nor initiation of alternative MS DMT or commercial ocrelizumab occurred, is reported. RCRM Model was used to estimate annual rate of change. | FAS included all randomized participants. Participants were grouped according to the treatment assigned at randomization. Overall number analyzed is the number of participants with data available for analysis. | Posted | Number | 95% Confidence Interval | percent change per year | From Week 24 up to approximately 120 weeks |
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| Secondary | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | AE was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is any AE that is: Fatal; Life-threatening; Requires or prolongs inpatient hospitalization; Results in persistent or significant disability/incapacity; A congenital anomaly/birth defect in a neonate/infant born to a mother exposed to study drug OR a significant medical event in the investigator's judgment. | Not Posted | Jan 2029 | From initiation of study drug up to approximately 10.5 years | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Serum Concentration of Ocrelizumab | Not Posted | Jan 2029 | Up to approximately 10.5 years | Participants | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | B-cell Levels in Blood | SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | cells/microliters (cells/μL) | Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
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| Secondary | Change From Baseline in B-cell Levels | SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Mean | Standard Deviation | cells/μL | Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
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| Secondary | Percentage of Participants With B-cell Counts ≤5 Cells/μL | Percentages have been rounded off. | SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
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| Secondary | Percentage of Participants With B-cell Counts ≤10 Cells/μL | Percentages have been rounded off. | SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they actually received. Overall number analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Number | percentage of participants | Baseline, Weeks 2, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204 and 228 |
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| Secondary | Number of Participants With ADAs to Ocrelizumab | Prevalence of ADAs at baseline is defined as the number of participants that is ADA positive at baseline. For determining post-baseline incidence, participants are considered to be ADA-positive if they are ADA-negative or have missing data at baseline but develop an ADA response following study drug exposure, or if they are ADA-positive at baseline and the titer of 1 or more post-baseline samples is at least 0.60 titer unit (t.u.) greater than the baseline titer result. | Not Posted | Jan 2029 | Baseline up to approximately 10.5 years | Participants |
AEs: From initiation of study drug up to end of DBT or follow-up 1 (up to 144 weeks) All-cause Mortality: up to approximately 65 months Data collected up to primary completion cut-off date is being reported here. Data collection for this study is still ongoing, and final data will be reported 1 year after the study completion date. As no dosing occurs in FU1, data for DBT and FU are reported together per actual treatment administered (OCR or Placebo).
SAS included all participants who received at least one infusion (partial or complete) of study drug. Participants were grouped according to the treatment they received.
1 participant randomized to the placebo group received a single dose of ocrelizumab & was included in the ocrelizumab group for the safety analysis. 1 participant in placebo group did not receive any study treatment & was not included in safety analysis.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocrelizumab | Participants received the first dose of ocrelizumab as two 300 mg IV infusions, administered 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W for 144 weeks during the DBT period. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. | 16 | 506 | 65 | 506 | 257 | 506 |
| EG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. | 14 | 506 | 68 | 506 | 201 | 506 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Atrial septal defect | Congenital, familial and genetic disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Anal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Gastric dilatation | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Haematochezia | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gallbladder fistula | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abscess neck | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Arthritis bacterial | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Gallbladder empyema | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hepatitis C | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Human anaplasmosis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumonia aspiration | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pyelonephritis acute | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Salpingo-oophoritis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Urosepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Chemical peritonitis | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Hip fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Ligament injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA Version 27.1 | Systematic Assessment |
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| Adult failure to thrive | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Prostate cancer stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Central nervous system mass | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Mental impairment | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Motor dysfunction | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Multiple sclerosis | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Multiple sclerosis pseudo relapse | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Progressive multiple sclerosis | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Quadriparesis | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Relapsing multiple sclerosis | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA Version 27.1 | Systematic Assessment |
| |
| Adjustment disorder | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Endometrial hyperplasia | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Endometriosis | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Vaginal cyst | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Laryngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tracheal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Tracheal resection | Surgical and medical procedures | MedDRA Version 27.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 4, 2025 | Jan 6, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D020528 | Multiple Sclerosis, Chronic Progressive |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C533411 | ocrelizumab |
Not provided
Not provided
Not provided
| Death |
|
| Withdrawal by Subject |
|
| Physician Decision |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Death |
|
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Discontinued and Entered FU2 |
|
| Lost to Follow-up |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|
| OG001 | Placebo | Participants received first dose of ocrelizumab matching placebo, as an IV infusion, administered 14 days apart. Thereafter, participants received ocrelizumab, matching placebo as a single IV infusion, Q24W for 144 weeks during the DBT periods. Participants who prematurely discontinued from DBT were followed in the FU1 phase. Participants who experienced a DPE during the DBT phase were given the option to switch to the PDP OCR phase after completing at least 120 weeks of DBT. Participants who either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis could continue to the Optional OLE Phase. In both PDP OCR and OLE phases, the first dose of ocrelizumab is administered as two 300 mg, IV infusions, 14 days apart. Thereafter, participants received ocrelizumab, 600 mg as a single IV infusion, Q24W. Participants who are ongoing in the FU1 phase at 144 weeks from randomization or at the time of the primary analysis, participants who have either completed 144 weeks of the DBT phase or are ongoing in the DBT phase at the time of the primary analysis and will not enter the OLE phase, participants who have completed or withdrawn from the OLE phase or from PDP OCR treatment phase will continue in FU2 phase for 24 weeks of FU. |
|
|