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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-000893-69 | EudraCT Number | ||
| 2023-506467-34-00 | Registry Identifier | EU CT Number |
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This is a randomized, double-blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and PK of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks (Q24W) in participants with RMS, in comparison to the approved 600 milligrams (mg) dose of ocrelizumab.
Participants will be treated for a minimum of 120 weeks in the double-blind treatment (DBT) phase. Upon positive primary results after the DBT phase, an optional higher dose extension treatment, open-label extension (OLE) phase is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the low level of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the LLN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab Higher Dose | Experimental | Participants will be randomized to receive a minimum of 5 higher treatment doses based on their body weight at baseline: 1200 mg (participant's body weight <75 kilograms [kg]) or 1800 mg (participant's body weight ≥ 75 kg) of ocrelizumab administered by IV infusion Q24W in the DBT phase. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion. |
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| Ocrelizumab Approved Dose | Active Comparator | Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by IV infusion Q24W in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight <75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) | Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of the 3 criteria: 1) CDP=12-week confirmed increase (CI) from baseline (FB) in expanded disability status scale (EDSS) score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 12-week CI of ≥20% FB in Timed 25-foot Walk Test (T25FWT) score OR 3)12-week CI of ≥ 20% FB in 9-hole Peg Test (9-HPT) score. EDSS = disability scale that ranges in 0.5-point steps from 0 [normal]-10.0 [death]. In T25FWT test participants walked to a 25 foot course as quickly & safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place & remove pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the amount of time (in seconds) required was recorded. In T25FWT & 9-HPT the longer it took complete test= higher scores, indicating deterioration. | Up to approximately 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Onset of 24-week cCDP (cCDP24) | Time to onset of a 24 week cCDP=first occurrence of a 24-week cCDP according to at least 1 of 3 criteria: 1) CDP=24-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 24-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 24-week CI of ≥20% FB in T25FWT score OR 3) 24-week CI of ≥ 20% FB in 9-HPT score. EDSS = disability scale that ranges in 0.5-point steps from 0 [normal]-10.0 [death]. In T25FWT test participants walked to a 25 foot course as quickly & safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place & remove pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the amount of time (in seconds) required was recorded. In T25FWT & 9-HPT the longer it took complete test= higher scores, indicating deterioration. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates | Cullman | Alabama | 35058 | United States | ||
| Alabama Neurology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42208560 | Derived | Hauser SL, Giovannoni G, Montalban X, Oh J, Bar-Or A, Sormani MP, Weber MS, Stoll S, Nicholas JA, Nehrych T, Bonek R, Selmaj K, Maciejowski M, Zecevic D, Raposo C, Owen R, Bonati U, Madjar K, Harfst E, Wang Q, Raievska A, Manfrini M, Schneble HM, Kappos L; MUSETTE and GAVOTTE Study Groups. Efficacy and safety of a bodyweight-adjusted higher dose of ocrelizumab in relapsing (MUSETTE) and primary progressive (GAVOTTE) multiple sclerosis: two multicentre, randomised, double-blind, parallel-group phase 3b trials. Lancet. 2026 May 30;407(10544):2180-2194. doi: 10.1016/S0140-6736(26)00147-9. |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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Participants received double-blinded treatment (DBT) with either ocrelizumab higher dose (1200 milligrams [mg] or 1800 mg) based on the participant's body weight (BW) or ocrelizumab 600 mg for a minimum of up to 120 weeks. 4 participants had a major good clinical practice (GCP) violation and were hence excluded from all analysis sets used in this study. Therefore, results are presented for 860 participants.
A total of 864 participants with relapsing multiple sclerosis (RMS) took part in the study at 122 investigative sites across 21 countries. The study is still ongoing.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocrelizumab 600 mg | Participants received ocrelizumab, 600 mg, as an intravenous (IV) infusion, every 24 weeks (Q24W). |
| FG001 | Ocrelizumab 1200 mg or 1800 mg | Participants received ocrelizumab 1200 mg (BW < 75 kilograms [kg]) or 1800 mg (BW ≥ 75 kg), as an IV infusion, Q24W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Dec 21, 2023 | Dec 17, 2025 |
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| Ocrelizumab | Drug | Ocrelizumab will be administered at a dose of 600 mg Q24W. 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 IV infusion Q24W. |
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| Antihistamine | Drug | Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion. |
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| Methylprednisolone | Drug | Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion. |
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| Up to approximately 4 years |
| Time to Onset of 48-week cCDP (cCDP48) | Time to onset of a 48-week cCDP=first occurrence of a 48-week cCDP according to at least 1 of 3 criteria: 1) CDP=48-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 48-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 48-week CI of ≥20% FB in T25FWT score OR 3) 48-week CI of ≥ 20% FB in 9-HPT score. EDSS = disability scale that ranges in 0.5-point steps from 0 [normal]-10.0 [death]. In T25FWT test participants walked to a 25 foot course as quickly & safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place & remove pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the amount of time (in seconds) required was recorded. In T25FWT & 9-HPT the longer it took complete test= higher scores, indicating deterioration. | Up to approximately 4 years |
| Time to Onset of cCDP12 Independent of Protocol-defined Relapses (PDR) or Progression Independent of Relapse Activity (PIRA) | Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of 3 criteria: 1) CDP=12-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 12-week CI of ≥20% FB in T25FWT score OR 3) 12-week CI of ≥ 20% FB in 9-HPT score. EDSS score, T25FWT & 9-HPT are the same as defined in primary outcome measure. Protocol-defined relapse=occurrence of new or worsening neurological symptoms attributable to MS and immediately preceded by a relatively stable or improving neurological state of at least 30 days. Symptoms persist for at least 24 hours & accompanied by objective neurological worsening consistent with an increase of one of the following: Half a step (0.5 point) on the EDSS; Two points on one of the functional system scores (FSS) (pyramidal, ambulation, cerebellar, brainstem, sensory, or visual); One point on ≥2 more of the FSS. | Up to approximately 4 years |
| Time to Onset of 12-week Confirmed Disability Progression (CDP12) | CDP was defined as a 12-week confirmed increase from baseline in EDSS score of ≥1.0 point in participants with a baseline EDSS score of ≤5.5 or a 12-week CI ≥0.5 points in participants with a baseline EDSS score of >5.5. The 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 and bladder, and 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 range 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 4 years |
| Time to ≥ 20% Increase in 12-week Confirmed T25FWT | T25FWT test is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant was directed to start at one end of a clearly marked 25-foot course and was instructed to walk 25 feet as quickly and safely as possible. The Examining Investigator timed the participants from the start of the walk to the end of the 25 feet. The task was immediately administered again by having the participant walk back the same distance. Participants could use assistive devices (e.g., cane, crutch, or rollator) when performing the task. Score was the average of the two completed trials, measured in seconds. The longer it takes to walk, higher the score, indicating deterioration. A 20% change from baseline of the averaged T25FWT was considered clinically meaningful. | Up to approximately 4 years |
| Annual Rate of Percent Change From Baseline in Total Brain Volume | Brain volume was measured using magnetic resonance imaging (MRI) scans. Mean difference in annual rate of percent change from baseline in total brain volume between the higher and approved dose of ocrelizumab arms in participants with RMS where no treatment discontinuation nor initiation of alternative MS treatment occurred, are reported. | Up to approximately 4 years |
| Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) | The SDMT is a performance measure that demonstrated sensitivity in detecting the presence of cognitive impairment and changes in cognitive functioning over time & in response to treatment. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants were asked to pair specific numbers with given geometric figures within 90 seconds. Responses were collected orally. The score is the number of correctly paired items in 90 seconds with a maximum score of 110 and minimum of 0. Higher scores indicate improvement. A four-point change from baseline was considered clinically meaningful. | Up to approximately 4 years |
| Time to Onset of 24-week Confirmed 8-point Increase in 12-item Multiple Sclerosis Walking Scale (MSWS-12) | The MSWS-12 was a 12-item self-report measure of the impact of MS on the participant's ability to walk during the past 2 weeks. Each item was scored on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely likely). Scores were summed and linearly converted to a 0-100 scale with higher scores indicating greater impact of MS on walking ability. An 8-point change was considered clinically meaningful. | Up to approximately 4 years |
| Fold Change From Baseline in Neurofilament Light (NfL) Chain at Week 48 for Participants Assigned to the Higher Dose Ocrelizumab Group | NfL is a biomarker of neuroinflammation in CSF. Ratio of change from baseline in NfL at Week 48 for RMS participants where no treatment discontinuation nor initiation of alternative MS treatment occurred within the ocrelizumab higher dose arm has been reported. The results correspond to fold change from baseline (ie ratio of adjusted geometric means at week 48 vs baseline). | Week 48 |
| Fold Change From Baseline in NfL Chain at Week 48 for Participants Assigned to the Approved Dose Ocrelizumab Group | NfL is a biomarker of neuroinflammation in CSF. Ratio of change from baseline in NfL at Week 48 for RMS participants where no treatment discontinuation nor initiation of alternative MS treatment occurred within the ocrelizumab approved dose arm has been reported. The results correspond to fold change from baseline (ie ratio of adjusted geometric means at week 48 vs baseline). | Week 48 |
| Number of Participants With Adverse Events (AEs) | AE is 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. | From initiation of study drug up to approximately 4 years |
| Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab Over the First Dosing Interval | Day 1 to Week 24 |
| B-cell Levels in Blood | Baseline, Weeks 2, 24, 48, 72, 96, 120, 144, 168, and 192 |
| Percent Change From Baseline in B-cell Levels | Weeks 2, 24, 48, 72, 96, 120, 144, 168, and 192 |
| Percentage of Participants Who Achieved ≤ 5 B-cells/μL of Blood | Baseline, Weeks 2, 24, 48, 72, 96, 120, 144, 168, and 192 |
| Percentage of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab | Prevalence of ADAs at baseline was defined as the percentage of participants that is ADA positive at baseline. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result. Percentages have been rounded off. | Baseline up to approximately 4 years |
| Homewood |
| Alabama |
| 35209 |
| United States |
| 21st Century Neurology | Phoenix | Arizona | 85004 | United States |
| Profound Research, LLC | Carlsbad | California | 92011 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| Advanced Neurology of Colorado, LLC | Fort Collins | Colorado | 80528 | United States |
| Neurology Associates, PA | Maitland | Florida | 32751 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| American Health Network Institute, LLC | Avon | Indiana | 46123 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| The NeuroMedical Clinic of Central Louisiana | Alexandria | Louisiana | 71301 | United States |
| Maine Medical Center | Scarborough | Maine | 04074 | United States |
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic Lou Ruvo | Las Vegas | Nevada | 89106 | United States |
| Dent Neurological Institute | Amherst | New York | 14226 | United States |
| UC Health Neurology | Dayton | Ohio | 45417 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Abington Neurological Associates | Willow Grove | Pennsylvania | 19090 | United States |
| Tri-State Mountain Neurology | Johnson City | Tennessee | 37604 | United States |
| Hope Neurology | Knoxville | Tennessee | 37922 | United States |
| Lone Star Neurology of San Antonio | San Antonio | Texas | 78258 | United States |
| Evergreen MS Center | Kirkland | Washington | 98034 | United States |
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR | Buenos Aires | C1424 | Argentina |
| CEMIC | Buenos Aires | C1431FWO | Argentina |
| Centro de Investigaciones Médicas Tucuman | San Miguel de Tucumán | T4000AXL | Argentina |
| Austin Hospital | Heidelberg | Victoria | 3084 | Australia |
| Hospital Erasme | Brussels | 1070 | Belgium |
| Revalidatie en MS Centrum | Overpelt | 3900 | Belgium |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| IMV Pesquisa Neurológica | Porto Alegre | Rio Grande do Sul | 90620-130 | Brazil |
| Clinica Neurologica | Joinville | Santa Catarina | 89201-165 | Brazil |
| CPQuali Pesquisa Clinica Ltda | São Paulo | São Paulo | 01228-000 | Brazil |
| Recherche Sepmus Inc. | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Centre de Recherche Saint-Louis | Lévis | Quebec | G6W 0M5 | Canada |
| Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark |
| Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| CHU Hopital Gabriel Montpied | Clermont-Ferrand | 63003 | France |
| CH St Vincent de Paul | Lille | 59000 | France |
| Hôpital Charles Nicolle | Rouen | 76031 | France |
| Charite - Universitätsmedizin Berlin | Berlin | 12203 | Germany |
| St. Josef-Hospital, Klinik für Neurologie | Bochum | 44791 | Germany |
| Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften | Dresden | 01307 | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | 24105 | Germany |
| Universität Leipzig | Leipzig | 04103 | Germany |
| Universitätsklinikum Tübingen, Zentrum für Neurologie | Tübingen | 72076 | Germany |
| Universitätsklinikum Ulm | Ulm | 89081 | Germany |
| Deutsche Klinik für Diagnostik | Wiesbaden | 65191 | Germany |
| 401 Military Hospital of Athens | Athens | 11525 | Greece |
| S-Medicon Egeszsegugyi Szolgaltato Kft. | Budapest | 1138 | Hungary |
| UNO Medical Trials Kft. | Budapest | 1152 | Hungary |
| Somogy Vármegyei Kaposi Mór Oktató Kórház | Kaposvár | 7400 | Hungary |
| Universita? G. D'Annunzio | Chieti | Abruzzo | 66100 | Italy |
| AOU Seconda Università degli Studi | Naples | Campania | 80131 | Italy |
| AOU Seconda Università degli Studi | Naples | Campania | 80138 | Italy |
| Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Rome | Lazio | 00133 | Italy |
| NCL Institute Neuroscience | Rome | Lazio | 00178 | Italy |
| Policlinico Umberto I | Rome | Lazio | 00185 | Italy |
| Fond. Istituto Neurologico C.Besta | Milan | Lombardy | 20133 | Italy |
| IRCCS Istituto Neurologico Neuromed | Pozzilli | Molise | 86077 | Italy |
| Hospital IV Alberto Sabogal Sologuren | Bellavista | Callao 2 | Peru |
| Clinica Internacional | Lima | 15001 | Peru |
| Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo | Lima | Lima 01 | Peru |
| Hospital Maria Auxiliadora | Lima | Lima 29 | Peru |
| Hospital Nacional Dos de Mayo | Lima | Peru |
| Clinica Sanchez Ferrer | Trujillo | Lima 13009 | Peru |
| Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | 85-796 | Poland |
| COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika | Gdansk | 80-803 | Poland |
| MA-LEK Clinical Sp. Z o.o. | Katowice | 40-571 | Poland |
| SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM | Lodz | 90-153 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | 90-324 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Lublin | 20-410 | Poland |
| EMC Instytut Medyczny SA | Późna | 60-309 | Poland |
| Nmedis sp. z o.o. | Rzeszów | 35-323 | Poland |
| Osrodek Badan Klinicznych Euromedis | Szczecin | 70-215 | Poland |
| Centrum Medyczne NeuroProtect | Warsaw | 01-684 | Poland |
| Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie | Warsaw | 02-097 | Poland |
| Instytut Psychiatrii i Neurologii II Klinika Neurologiczna | Warsaw | 02-957 | Poland |
| Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy | Warsaw | 04-141 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz | Lisbon | 1349-019 | Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency | Krasnoyarsk | Krasnoyarsk Krai | 660037 | Russia |
| Neiro Clinica LLC | Moscow | Moscow Oblast | 117186 | Russia |
| Research Center of Neurology of RAMS | Moscow | Moscow Oblast | 125367 | Russia |
| Federal center of brain research and neurotechnologies | Moskva | Moscow Oblast | 117997 | Russia |
| City Clinical Hospital #24 | Moskva | Moscow Oblast | 127015 | Russia |
| National Center of Social Significant Disease | Saint Petersburg | Sankt-Peterburg | 197110 | Russia |
| N.P. Bechtereva Institute of the Human Brain | Saint Petersburg | Sankt-Peterburg | 197376 | Russia |
| City Hospital #40 of Kurortniy Administrative District | Saint Petersburg | Sankt-Peterburg | 197706 | Russia |
| SHI Sverdlovsk Regional Clinical Hospital #1 | Yekaterinburg | Sverdlovsk Oblast | 620102 | Russia |
| Vertebronevrologiya LLC | Kazan' | Tatarstan Republic | 420047 | Russia |
| KSMU Interregional Clinical Diagnostic Centre | Kazan' | Tatarstan Republic | 420101 | Russia |
| Ulyanovsk Regional Clinical Hospital | Ulyanovsk | Ulyanovsk Oblast | 432063 | Russia |
| Saratov State Medical University of RosZdrav | Saratov | 410012 | Russia |
| Nebbiolo Center for Clinical Trials | Tomsk | 634009 | Russia |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | LA Coruna | 15006 | Spain |
| Hospital Quiron de Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Hospital Alvaro Cunqueiro | Vigo | Pontevedra | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Regional Universitario de Malaga ? Hospital General | Málaga | 29010 | Spain |
| Universitätsspital Basel Medizin Neurologie | Basel | 4031 | Switzerland |
| Inselspital Bern Medizin Neurologie | Bern | 3010 | Switzerland |
| Ospedale Regionale di Lugano - Civico | Lugano | 6903 | Switzerland |
| Kocaeli University Hospital | Kocaeli | 41380 | Turkey (Türkiye) |
| 5th Cherkasy City Center of Primary Health Care | Cherkasy | 18029 | Ukraine |
| Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.? | Chernihiv | 14029 | Ukraine |
| Bukovinsky SMU RMI Chernivtsi RCH | Chernivtsi | 58002 | Ukraine |
| SI USSRI of Medical and Social Problems of Disabilities of MOHU | Dnipro | 49027 | Ukraine |
| Regional Clinical Hospital | Ivano-Frankivsk | 76008 | Ukraine |
| Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | 61058 | Ukraine |
| St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU | Kharkiv | 61068 | Ukraine |
| Medical Center of Private Execution First Private Clinic | Kyiv | 03037 | Ukraine |
| Medical Center Dopomoga Plus | Kyiv | 03143 | Ukraine |
| Lvivska oblasna tsentralna likarnia | Lviv | 79010 | Ukraine |
| LCC "Medical center "Unimed" | Zaporizhzhia | 69035 | Ukraine |
| Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council | Zaporizhzhia | 69600 | Ukraine |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocrelizumab 600 mg | Participants received ocrelizumab, 600 mg, as an IV infusion, Q24W. |
| BG001 | Ocrelizumab 1200 mg or 1800 mg | Participants received ocrelizumab 1200 mg (BW < 75 kg) or 1800 mg (BW ≥ 75 kg), as an IV infusion, Q24W. |
| 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 | ||||||||||
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| 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 |
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| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Time to Onset of 12-week Composite Confirmed Disability Progression (cCDP12) | Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of the 3 criteria: 1) CDP=12-week confirmed increase (CI) from baseline (FB) in expanded disability status scale (EDSS) score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 12-week CI of ≥20% FB in Timed 25-foot Walk Test (T25FWT) score OR 3)12-week CI of ≥ 20% FB in 9-hole Peg Test (9-HPT) score. EDSS = disability scale that ranges in 0.5-point steps from 0 [normal]-10.0 [death]. In T25FWT test participants walked to a 25 foot course as quickly & safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place & remove pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the amount of time (in seconds) required was recorded. In T25FWT & 9-HPT the longer it took complete test= higher scores, indicating deterioration. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Time to Onset of 24-week cCDP (cCDP24) | Time to onset of a 24 week cCDP=first occurrence of a 24-week cCDP according to at least 1 of 3 criteria: 1) CDP=24-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 24-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 24-week CI of ≥20% FB in T25FWT score OR 3) 24-week CI of ≥ 20% FB in 9-HPT score. EDSS = disability scale that ranges in 0.5-point steps from 0 [normal]-10.0 [death]. In T25FWT test participants walked to a 25 foot course as quickly & safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place & remove pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the amount of time (in seconds) required was recorded. In T25FWT & 9-HPT the longer it took complete test= higher scores, indicating deterioration. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Time to Onset of 48-week cCDP (cCDP48) | Time to onset of a 48-week cCDP=first occurrence of a 48-week cCDP according to at least 1 of 3 criteria: 1) CDP=48-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 48-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 48-week CI of ≥20% FB in T25FWT score OR 3) 48-week CI of ≥ 20% FB in 9-HPT score. EDSS = disability scale that ranges in 0.5-point steps from 0 [normal]-10.0 [death]. In T25FWT test participants walked to a 25 foot course as quickly & safely as possible. Score = average of 2 completed trials (in seconds). In 9-HPT, participants had to place & remove pegs 1 by 1 into 9 holes arranged in a board & complete 2 successful trials for each hand & the amount of time (in seconds) required was recorded. In T25FWT & 9-HPT the longer it took complete test= higher scores, indicating deterioration. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Time to Onset of cCDP12 Independent of Protocol-defined Relapses (PDR) or Progression Independent of Relapse Activity (PIRA) | Time to onset of 12-week cCDP=first occurrence of a 12-week cCDP according to at least 1 of 3 criteria: 1) CDP=12-week CI from baseline in EDSS score of ≥1.0 point in participants with baseline EDSS score of ≤5.5 or 12-week CI≥0.5 point in participants with baseline EDSS score of >5.5 OR 2) 12-week CI of ≥20% FB in T25FWT score OR 3) 12-week CI of ≥ 20% FB in 9-HPT score. EDSS score, T25FWT & 9-HPT are the same as defined in primary outcome measure. Protocol-defined relapse=occurrence of new or worsening neurological symptoms attributable to MS and immediately preceded by a relatively stable or improving neurological state of at least 30 days. Symptoms persist for at least 24 hours & accompanied by objective neurological worsening consistent with an increase of one of the following: Half a step (0.5 point) on the EDSS; Two points on one of the functional system scores (FSS) (pyramidal, ambulation, cerebellar, brainstem, sensory, or visual); One point on ≥2 more of the FSS. | FAS included all randomized participants. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Time to Onset of 12-week Confirmed Disability Progression (CDP12) | CDP was defined as a 12-week confirmed increase from baseline in EDSS score of ≥1.0 point in participants with a baseline EDSS score of ≤5.5 or a 12-week CI ≥0.5 points in participants with a baseline EDSS score of >5.5. The 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 and bladder, and 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 range 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. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Time to ≥ 20% Increase in 12-week Confirmed T25FWT | T25FWT test is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant was directed to start at one end of a clearly marked 25-foot course and was instructed to walk 25 feet as quickly and safely as possible. The Examining Investigator timed the participants from the start of the walk to the end of the 25 feet. The task was immediately administered again by having the participant walk back the same distance. Participants could use assistive devices (e.g., cane, crutch, or rollator) when performing the task. Score was the average of the two completed trials, measured in seconds. The longer it takes to walk, higher the score, indicating deterioration. A 20% change from baseline of the averaged T25FWT was considered clinically meaningful. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Annual Rate of Percent Change From Baseline in Total Brain Volume | Brain volume was measured using magnetic resonance imaging (MRI) scans. Mean difference in annual rate of percent change from baseline in total brain volume between the higher and approved dose of ocrelizumab arms in participants with RMS where no treatment discontinuation nor initiation of alternative MS treatment occurred, are reported. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | Mean | Standard Error | percent change per year | Up to approximately 4 years |
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| Secondary | Time to Onset of 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT) | The SDMT is a performance measure that demonstrated sensitivity in detecting the presence of cognitive impairment and changes in cognitive functioning over time & in response to treatment. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants were asked to pair specific numbers with given geometric figures within 90 seconds. Responses were collected orally. The score is the number of correctly paired items in 90 seconds with a maximum score of 110 and minimum of 0. Higher scores indicate improvement. A four-point change from baseline was considered clinically meaningful. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Time to Onset of 24-week Confirmed 8-point Increase in 12-item Multiple Sclerosis Walking Scale (MSWS-12) | The MSWS-12 was a 12-item self-report measure of the impact of MS on the participant's ability to walk during the past 2 weeks. Each item was scored on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely likely). Scores were summed and linearly converted to a 0-100 scale with higher scores indicating greater impact of MS on walking ability. An 8-point change was considered clinically meaningful. | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | Median | 95% Confidence Interval | weeks | Up to approximately 4 years |
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| Secondary | Fold Change From Baseline in Neurofilament Light (NfL) Chain at Week 48 for Participants Assigned to the Higher Dose Ocrelizumab Group | NfL is a biomarker of neuroinflammation in CSF. Ratio of change from baseline in NfL at Week 48 for RMS participants where no treatment discontinuation nor initiation of alternative MS treatment occurred within the ocrelizumab higher dose arm has been reported. The results correspond to fold change from baseline (ie ratio of adjusted geometric means at week 48 vs baseline). | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | Mean | 95% Confidence Interval | ratio | Week 48 |
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| Secondary | Fold Change From Baseline in NfL Chain at Week 48 for Participants Assigned to the Approved Dose Ocrelizumab Group | NfL is a biomarker of neuroinflammation in CSF. Ratio of change from baseline in NfL at Week 48 for RMS participants where no treatment discontinuation nor initiation of alternative MS treatment occurred within the ocrelizumab approved dose arm has been reported. The results correspond to fold change from baseline (ie ratio of adjusted geometric means at week 48 vs baseline). | FAS included all randomized participants. Overall number analyzed is the number of participants with data available for analysis. | Posted | Mean | 95% Confidence Interval | ratio | Week 48 |
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| Secondary | Number of Participants With Adverse Events (AEs) | AE is 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. | Safety analysis set (SAS) included all participants who received at least one infusion (partial or complete) of the study drug. Participants were included in the analyses according to the treatment they received. | Posted | Count of Participants | Participants | From initiation of study drug up to approximately 4 years |
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| Secondary | Area Under the Serum Concentration-Time Curve (AUC) of Ocrelizumab Over the First Dosing Interval | The pharmacokinetic (PK) analysis data set included all participants with at least one measurable PK value. Participants were included in the analysis according to the treatment they received. Number analyzed is the number of participants with data available for analysis for a specific dose. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms/milliliter*day (µg/mL*day) | Day 1 to Week 24 |
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| Secondary | B-cell Levels in Blood | SAS included all participants who received at least one infusion (partial or complete) of the study drug. Participants were included in the analyses according to the treatment they 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, 24, 48, 72, 96, 120, 144, 168, and 192 |
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| Secondary | Percent Change From Baseline in B-cell Levels | SAS included all participants who received at least one infusion (partial or complete) of the study drug. Participants were included in the analyses according to the treatment they 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 | percent change | Weeks 2, 24, 48, 72, 96, 120, 144, 168, and 192 |
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| Secondary | Percentage of Participants Who Achieved ≤ 5 B-cells/μL of Blood | SAS included all participants who received at least one infusion (partial or complete) of the study drug. Participants were included in the analyses according to the treatment they 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, 24, 48, 72, 96, 120, 144, 168, and 192 |
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| Secondary | Percentage of Participants With Anti-drug Antibodies (ADAs) to Ocrelizumab | Prevalence of ADAs at baseline was defined as the percentage of participants that is ADA positive at baseline. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer unit (t.u.) greater than the baseline titer result. Percentages have been rounded off. | Immunogenicity analysis set included all participants with at least one ADA assessment. Participants were included in the analysis according to the treatment they received. Number analyzed is the number of participants with data available for analysis at the specified timepoint. | Posted | Number | percentage of participants | Baseline up to approximately 4 years |
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From initiation of study drug up to approximately 4 years
SAS included all participants who received at least one infusion (partial or complete) of the study drug. Participants were included in the analyses according to the treatment they received.
Data collected up to primary completion date is being reported here. Data collection is still ongoing, and final data will be reported one year after the study completion date.
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 600 mg | Participants received ocrelizumab, 600 mg, as an IV infusion, Q24W. | 1 | 283 | 34 | 283 | 241 | 283 |
| EG001 | Ocrelizumab 1200 mg or 1800 mg | Participants received ocrelizumab 1200 mg (BW < 75 kg) or 1800 mg (BW ≥ 75 kg), as an IV infusion, Q24W. | 4 | 577 | 77 | 577 | 502 | 577 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Drowning | 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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| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Bile duct stenosis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholecystitis acute | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholecystitis chronic | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Anal abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Bone tuberculosis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Coronavirus pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Dengue fever | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Gastroenteritis viral | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Hepatitis A | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Herpes virus infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Human anaplasmosis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Meningitis aseptic | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pilonidal disease | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumococcal infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumonia influenzal | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Postoperative wound infection | 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 |
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| Renal abscess | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Secondary syphilis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Tubo-ovarian abscess | 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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| Urogenital trichomoniasis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Epiphyseal 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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| Fracture displacement | 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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| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumothorax traumatic | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Poisoning deliberate | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Radius fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Sternal fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Hepatic enzyme increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
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| Transaminases increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
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| Diabetic metabolic decompensation | 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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| Hepatic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Neurilemmoma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Neuroendocrine tumour of the lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Systematic Assessment |
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| Pituitary tumour | 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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| Generalised tonic-clonic seizure | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Middle cerebral artery stroke | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Multiple sclerosis pseudo relapse | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Trigeminal neuralgia | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Premature labour | Pregnancy, puerperium and perinatal conditions | MedDRA Version 27.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Depression suicidal | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Mixed anxiety and depressive disorder | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Suicidal ideation | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Calculus urinary | Renal and urinary disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Abnormal uterine bleeding | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Breast calcifications | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Endometriosis | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Ovarian cyst | Reproductive system and breast disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Chronic rhinosinusitis with nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Vocal cord cyst | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA Version 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA Version 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | 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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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Systematic Assessment |
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| Weight increased | Investigations | MedDRA Version 27.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA Version 27.1 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Systematic Assessment |
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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 | Feb 18, 2025 | Dec 17, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C533411 | ocrelizumab |
| D006633 | Histamine Antagonists |
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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