Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.
Participants who complete their Week 72 ocrelizumab infusion and do not experience any serious infusion related reaction (IRR) throughout the main study will be eligible to enroll in an optional, open-label, non-randomized substudy to MN30035 and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. This substudy will enroll approximately 100 patients from MN30035 main study.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks). |
|
| Ocrelizumab (substudy) | Experimental | Participants with no serious IRR throughout the main study will be eligible to enroll in an optional substudy and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab will be administered IV as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period | Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks. | Baseline up to Week 96 |
| Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy | Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion | Week 96 to Week 100 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period | Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks. | Baseline up to Weeks 24 and 48 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | ||
| Phoenix Neurological Associates Ltd |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42328798 | Derived | Vermersch P, Benedict RHB, Van Wijmeersch B, Cutter G, Kister L, Oreja-Guevara C, Siva A, Wiendl H, Wuerfel J, El Azzouzi B, Kuenzel T, Buffels R, Craveiro L, Dirks P, Comi G. Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial. Eur J Neurol. 2026 Jun;33(6):e70628. doi: 10.1111/ene.70628. |
Not provided
Not provided
Participants with relapsing remitting multiple sclerosis (RRMS) were enrolled, who had had a suboptimal response to an adequate course of a disease-modifying treatment (DMT). An adequate course of prior DMT was defined as the same DMT administered for at least 6 months.
The study was conducted in North America at 90 study sites in the U.S. and Canada.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ocrelizumab | Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks) |
| FG001 | Ocrelizumab (Substudy) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Study (Baseline to Week 100) |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 19, 2018 | Apr 15, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ocrelizumab | Drug | Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours) |
|
|
| Time to Protocol-Defined Event | Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks. | Baseline up to Week 96 |
| Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period | Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS <2.5 vs. >=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. >1) | Baseline up to Week 96 |
| Time to Onset of First Protocol-Defined Relapse | Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. | Baseline up to Week 96 |
| Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI | Baseline up to Week 96 |
| Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI | Baseline up to Week 96 |
| Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score | Baseline up to Week 96 |
| Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI | The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis. | Weeks 24, 48, and 96 |
| Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI | Baseline data is represented as mean; post-Baseline date are represented as mean changes. | Baseline, Weeks 24, 48, and 96 |
| Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI | Weeks 24, 48, and 96 |
| Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Baseline up to 100 weeks |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States |
| Territory Neurology and Research Institute | Tucson | Arizona | 85704 | United States |
| The Research Center of Southern California, LLC | Carlsbad | California | 92011 | United States |
| Mercy Medical Group; MS Centre Nurse | Carmichael | California | 95608 | United States |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | United States |
| Scripps Health | La Jolla | California | 92037 | United States |
| UCSF- Multiple Sclerosis Centre; Department of Neurology | San Francisco | California | CA94158 | United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| Mountain Neurological Research Center; Roaring Fork Neurologt, P.C. | Basalt | Colorado | 81621 | United States |
| IMMUNOe Research Centers | Centennial | Colorado | 80112 | United States |
| Colorado Neurological Institute | Englewood | Colorado | 80113 | United States |
| Advanced Neurology of Colorado, LLC | Fort Collins | Colorado | 80528 | United States |
| Associated Neurologists of Southern CT PC | Fairfield | Connecticut | 06824 | United States |
| KI Health Partners, LLC; New England Institute for Clinical Research | Stamford | Connecticut | 06905 | United States |
| Neurology Associates PA | Maitland | Florida | 32751 | United States |
| University of Miami Miller School of Medicine; Clinical Reseach Building | Miami | Florida | 33136 | United States |
| Neurostudies Inc | Port Charlotte | Florida | 33952 | United States |
| Infinity Clinical Research, LLC | Sunrise | Florida | 33351 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| University of South Florida - Bradenton | Tampa | Florida | 33612 | United States |
| Ms Center Of Atlanta | Atlanta | Georgia | 30327 | United States |
| University of Chicago Hospital | Chicago | Illinois | 60637 | United States |
| Consultants in Neurology Ltd | Northbrook | Illinois | 60062 | United States |
| American Health Network Institute, LLC | Avon | Indiana | 46123 | United States |
| Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana | 46256 | United States |
| University of Kansas Medical Center; Division of Nuclear Medicine | Kansas City | Kansas | 66160 | United States |
| Lahey Clinic Med Ctr | Lexington | Kentucky | 02421 | United States |
| Associates in Neurology PSC | Lexington | Kentucky | 40513 | United States |
| Community Medical Associates Inc.; d.b.a. Norton Neurology Services MS Services | Louisville | Kentucky | 40207 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| University of Maryland Medical Center; Department of Neurology | Baltimore | Maryland | 21201 | United States |
| John Hopkins University School of Medicine | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Med Ctr; Neurology/MS Center | Boston | Massachusetts | 02215 | United States |
| Dragonfly Research, LLC | Wellesley | Massachusetts | 02481 | United States |
| UMASS Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Wayne State University; Department of Neurology | Detroit | Michigan | 48201 | United States |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | United States |
| Washington University School of Medicine; Department of Neurology | St Louis | Missouri | 63110 | United States |
| Cleveland Clinic Lou Ruvo; Center for Brain Research | Las Vegas | Nevada | 89106 | United States |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | United States |
| Holy Name Hospital; Institute For Clinical Research | Teaneck | New Jersey | 07666 | United States |
| Jacobs Neurological Institute | Buffalo | New York | 14203 | United States |
| The MS Center of Northeastern New York | Latham | New York | 12110 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| South Shore Neurologic Associates P.C. | Patchogue | New York | 11772 | United States |
| Island Neurological Associates, P.C. | Plainview | New York | 11803 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6520 | United States |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45267 | United States |
| Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40 | Cleveland | Ohio | 44195 | United States |
| The Ohio State University Wexner Medical Center; Department of Neurology | Columbus | Ohio | 43210 | United States |
| Neurology Specialists, Inc | Dayton | Ohio | 45417 | United States |
| Neurology and Neuroscience Assoc., Inc. | Westerville | Ohio | 43081 | United States |
| Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Multiple Sclerosis Center | Portland | Oregon | 97225 | United States |
| Allegheny Neurological Associates | Pittsburgh | Pennsylvania | 15212 | United States |
| Neurology Clinic PC | Cordova | Tennessee | 38018 | United States |
| Hope Neurology | Knoxville | Tennessee | 37922 | United States |
| Uni of Texas Health Science Center At Houston | Houston | Texas | 77030 | United States |
| Bhupesh Dihenia M.D. P.A. | Lubbock | Texas | 79410 | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | United States |
| Neurology Center of San Antonio | San Antonio | Texas | 78212 | United States |
| Rocky Mountain MS Clinic | Salt Lake City | Utah | 84103 | United States |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | United States |
| MultiCare Health System Institute for Research and Innovation | Tacoma | Washington | 98405 | United States |
| Foothills Medical Centre; Centre Dept of Medical Clinical Neuroscience | Calgary | Alberta | T2N 2T9 | Canada |
| University of Alberta; Divison of Pulmonary Medicine, Dept. of Medicine, | Edmonton | Alberta | T6C 2G3 | Canada |
| Fraser Health Multiple Sclerosis Clinic; Burnaby Hospital Pharmacy | Burnaby | British Columbia | V5G 2X6 | Canada |
| Horizon Health Network - Multiple Sclerosis Clinic | Saint John | New Brunswick | E2L 4L2 | Canada |
| Dalhousie Multiple Sclerosis Research Unit | Halifax | Nova Scotia | B3H 4K4 | Canada |
| Hamilton General Hospital | Hamilton | Ontario | L8L 2X2 | Canada |
| The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis | Ottawa | Ontario | K1H 8L6 | Canada |
| St. Michael's Hospital MS Clinic, MS Research Centre | Toronto | Ontario | Canada |
| Clinique NeuroOutaouais | Gatineau | Quebec | J8Y 1W2 | Canada |
| Recherche Sepmus, Inc. | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Hopital Hotel Dieu de Levis | Lévis | Quebec | G6V 3Z1 | Canada |
| Chum Campus Notre Dame | Montreal | Quebec | H2X 0A9 | Canada |
| McGill University; Montreal Neurological Institute; Neurological and Psychiatric | Montreal | Quebec | H3A 2B4 | Canada |
| MS Clinic Mauricie Bois Francs | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| CHU De Quebec Universite Laval | Québec | G1J 1Z4 | Canada |
Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Sub-Study (Week 72 to Week 100) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocrelizumab | Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| 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 | Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period | Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks. | The modified Intent-to-Treat (mITT) population was a subset of the ITT population which excluded participants who discontinued ocrelizumab treatment early without any protocol-defined events for reasons other than death and lack of efficacy. Only participants for whom data were collected are included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to Week 96 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period | Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks. | The modified Intent-to-Treat (mITT) population was a subset of the ITT population which excluded participants who discontinued ocrelizumab treatment early without any protocol-defined events for reasons other than death and lack of efficacy. Only participants for whom data were collected are included in the analysis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to Weeks 24 and 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Protocol-Defined Event | Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks. | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 96 |
|
| ||||||||||||||||||||||||||
| Secondary | Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period | Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS <2.5 vs. >=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. >1) | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Number | 95% Confidence Interval | Number of Relapses/Participant Year | Baseline up to Week 96 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Onset of First Protocol-Defined Relapse | Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 96 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to Week 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI | The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis. | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis. | Posted | Number | Number of Lesions | Weeks 24, 48, and 96 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI | Baseline data is represented as mean; post-Baseline date are represented as mean changes. | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis. | Posted | Mean | Standard Error | cubic centimeter (cm3) | Baseline, Weeks 24, 48, and 96 |
|
| ||||||||||||||||||||||||||
| Secondary | Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis. | Posted | Number | Number of Lesions | Weeks 24, 48, and 96 |
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Adverse Events | An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab | Posted | Number | Percentage of Participants | Baseline up to 100 weeks |
|
| |||||||||||||||||||||||||||
| Primary | Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy | Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion | Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious IRRs throughout the main study | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 96 to Week 100 |
|
|
Baseline up to 100 weeks
The Safety Population included all enrolled participants who received any ocrelizumab.
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 ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks) | 0 | 608 | 47 | 608 | 406 | 608 |
| EG001 | Ocrelizumab (Substudy) | Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours) | 0 | 129 | 2 | 129 | 16 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Wolff-Parkinson-White syndrome | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Mastoid effusion | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Systemic inflammatory response syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Kidney infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Adenocarcinoma of the cervix | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac ablation | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| Fibromuscular dysplasia | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | 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 | Apr 30, 2019 | Apr 15, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| C533411 | ocrelizumab |
Not provided
Not provided
Not provided
| Not Stated |
|
| Unknown |
|
| Black or African American |
|
| Multiple |
|
| Native Hawaiian or other Pacific Islande |
|
| Unknown |
|
| White |
|
|
|
|
|
|
|
|
|
|
|
|
|