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The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with progressive Multiple Sclerosis (PMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants randomized to receive placebo by intravenous infusion. |
|
| Elezanumab 400mg Dose | Experimental | Participants randomized to receive 400mg of elezanumab by intravenous infusion. |
|
| Elezanumab 1800 mg Dose | Experimental | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elezanumab | Drug | solution for infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Disability Improvement Response Rate | Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT). | Week 52 |
| Overall Response Score (ORS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Josephs Hospital and Med Center /ID# 202809 | Phoenix | Arizona | 85013 | United States | ||
| Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 202448 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below.
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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A total of 123 subjects from 35 sites in the United States & Canada were enrolled into the study, were randomized, and received at least 1 dose of study drug. Of these, 108 completed treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants randomized to receive placebo by intravenous infusion. placebo: solution for infusion |
| FG001 | Elezanumab 400mg Dose | Participants randomized to receive 400mg of elezanumab by intravenous infusion. elezanumab: solution for infusion |
| 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 | Mar 19, 2021 | Nov 14, 2023 |
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| placebo | Drug | solution for infusion |
|
The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). |
| Week 12 |
| Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4. | Week 24 |
| Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4. | Week 36 |
| Berkeley |
| California |
| 94705-2017 |
| United States |
| The Research Center of Southern California /ID# 202802 | Carlsbad | California | 92011-4213 | United States |
| Vladimir Royter MD /ID# 202483 | Hanford | California | 93230-5787 | United States |
| Stanford MS Center /ID# 202445 | Palo Alto | California | 94304-1416 | United States |
| UC Davis Health-Neurological Surgery /ID# 202485 | Sacramento | California | 95817-2307 | United States |
| UCSF School of Medicine - Neurology /ID# 203194 | San Francisco | California | 94143-0003 | United States |
| University of Colorado School of Medicine, Dept of Neurology /ID# 202807 | Aurora | Colorado | 80045-2527 | United States |
| Advanced Neurosciences Research, LLC /ID# 203072 | Fort Collins | Colorado | 80528 | United States |
| Rowe Neurology Institute /ID# 202744 | Lenexa | Kansas | 66214 | United States |
| Duplicate_Parexel International /ID# 202747 | Baltimore | Maryland | 21225 | United States |
| International Neurorehabilitation Institute /ID# 213333 | Lutherville | Maryland | 21093-6016 | United States |
| Michigan Institute for Neurological Disorders (MIND) /ID# 202470 | Farmington Hills | Michigan | 48334 | United States |
| Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206327 | Owosso | Michigan | 48867-2116 | United States |
| Ridgeview Specialty Clinic Chaska - Neurology /ID# 204384 | Chaska | Minnesota | 55318-4551 | United States |
| Washington University-School of Medicine /ID# 202899 | St Louis | Missouri | 63110 | United States |
| The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205432 | St Louis | Missouri | 63131-2322 | United States |
| Cleveland Clinic Lou Ruvo Cent /ID# 204744 | Las Vegas | Nevada | 89106-0100 | United States |
| Oklahoma Med Res. Foundation /ID# 203442 | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Neurological Specialties - West /ID# 203193 | Portland | Oregon | 97225-6646 | United States |
| Advanced Neurosciences Institute /ID# 204555 | Franklin | Tennessee | 37064 | United States |
| KCA Neurology - Franklin /ID# 202912 | Franklin | Tennessee | 37067-5914 | United States |
| Neurology Consultants of Dallas - LBJ Fwy /ID# 203102 | Dallas | Texas | 75243-1188 | United States |
| Central Texas Neurology Consul /ID# 203108 | Round Rock | Texas | 78681 | United States |
| Integrated Neurology Services /ID# 202743 | Alexandria | Virginia | 22310 | United States |
| Evergreen Neuroscience Institute /ID# 204205 | Kirkland | Washington | 98034-3029 | United States |
| Virginia Mason Medical Center /ID# 205439 | Seattle | Washington | 98101 | United States |
| Swedish MS Center /ID# 202904 | Seattle | Washington | 98122-5698 | United States |
| West Virginia Univ School Med /ID# 202849 | Morgantown | West Virginia | 26506 | United States |
| Froedtert Memorial Lutheran Hospital /ID# 202618 | Milwaukee | Wisconsin | 53226-3522 | United States |
| University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 203536 | Vancouver | British Columbia | V6T 1Z3 | Canada |
| Duplicate_London Health Sciences Centre - University Hospital /ID# 203538 | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital Research Institute /ID# 203058 | Ottawa | Ontario | K1H 8L6 | Canada |
| Unity Health Toronto - St. Michael's Hospital /ID# 206213 | Toronto | Ontario | M5B 1W8 | Canada |
| Recherche Sepmus Inc. /ID# 212852 | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 203869 | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Institut /ID# 203868 | Montreal | Quebec | H3A 2B4 | Canada |
| FG002 | Elezanumab 1800 mg Dose | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. elezanumab: solution for infusion |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to receive placebo by intravenous infusion. placebo: solution for infusion |
| BG001 | Elezanumab 400mg Dose | Participants randomized to receive 400mg of elezanumab by intravenous infusion. elezanumab: solution for infusion |
| BG002 | Elezanumab 1800 mg Dose | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. elezanumab: solution for infusion |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Type of MS | 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 | Mean Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS: Timed 25-Foot Walk, 9-Hole Peg Test-dominant, and 9-Hole Peg Test-nondominant and ranges from -4 to + 4. | The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 52 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Disability Improvement Response Rate | Disability improvement response rate is assessed based on the Expanded Disability Status Scale Plus (EDSS+). EDSS+ is comprised of Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT). | The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Week 52 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). | The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 12 |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4. | The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 24 |
| |||||||||||||||||||||||||||||||||
| Secondary | Overall Response Score (ORS) | The ORS is a composite score derived from 4 components: Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk (T25FW), 9-Hole Peg Test in the dominant hand (9HPT-D), and 9HPT in the non-dominant hand (9HPT-ND). Clinically significant worsening = -1, no change = 0, clinically significant improvement = +1. The ORS is the sum of these scores for the EDSS, Timed 25-Foot Walk, 9-Hole Peg Test-dominant and 9-Hole Peg Test-non-dominant and ranges from -4 to + 4. | The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Week 36 |
|
Up to 76 weeks
Adverse Events were collected for all study participants, whether solicited or spontaneously reported by the study participant throughout the study, who received at least 1 dose of study drug and for a period of up to 39 weeks after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants randomized to receive placebo by intravenous infusion. Placebo: solution for infusion | 1 | 43 | 2 | 43 | 34 | 43 |
| EG001 | Elezanumab 400mg Dose | Participants randomized to receive 400mg of elezanumab by intravenous infusion. Elezanumab: solution for infusion | 1 | 40 | 5 | 40 | 29 | 40 |
| EG002 | Elezanumab 1800 mg Dose | Participants randomized to receive 1800mg of elezanumab by intravenous infusion. Elezanumab: solution for infusion | 0 | 40 | 3 | 40 | 31 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPERTHYROIDISM | Endocrine disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INTESTINAL PSEUDO-OBSTRUCTION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHILLS | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| DIVERTICULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| PATELLA FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| DIABETIC KETOACIDOSIS | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SYNCOPE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| UHTHOFF'S PHENOMENON | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| VERTIGO | Ear and labyrinth disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHEST DISCOMFORT | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| CELLULITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HYPOAESTHESIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MUSCLE SPASTICITY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| NEURALGIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PARAESTHESIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SLEEP DISORDER | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DERMATITIS CONTACT | Skin and subcutaneous tissue disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HOT FLUSH | Vascular disorders | MedDRA 24.0 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-699-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 6, 2021 | Nov 14, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020528 | Multiple Sclerosis, Chronic Progressive |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000723102 | elezanumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
| Non-relapsing secondary progressive multiple sclerosis (nrSPMS) |
|
| Participants |
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|