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The purpose of this study is to evaluate the safety and efficacy of elezanumab in participants with relapsing Multiple Sclerosis (RMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants randomized to receive double-blind placebo by intravenous infusion. |
|
| Elezanumab Dose 1 | Experimental | Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion. |
|
| Elezanumab Dose 2 | Experimental | Participants randomized to receive double-blind elezanumab Dose 2 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) at Week 52 | 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 EDSS, Timed 25-Foot Walk (T25FW) and 9-Hole Peg Tests (9HPT). | Week 52 |
| Overall Response Score (ORS) |
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Inclusion Criteria:
Exclusion Criteria:
- Participants must not have experienced or be recovering from a clinical MS relapse within 6 months of Screening.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham - Main /ID# 204618 | Birmingham | Alabama | 35233 | United States | ||
| St. Josephs Hospital and Med Center /ID# 204197 |
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 208 subjects from 44 sites in the United States & Canada were enrolled into the study and were randomized: 208 subjects received at least 1 dose of study drug. Of the 208 subjects who received study drug, 182 completed treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants randomized to receive double-blind placebo by intravenous infusion. placebo: solution for infusion |
| FG001 | Elezanumab Dose 1 | Participants randomized to receive double-blind elezanumab Dose 1 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 22, 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). 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 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 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Sutter East Bay Medical Foundation-Jordon Research and Education Dev. Inst. /ID# 204249 | Berkeley | California | 94705-2017 | United States |
| The Research Center of Southern California /ID# 204269 | Carlsbad | California | 92011-4213 | United States |
| Vladimir Royter MD /ID# 204392 | Hanford | California | 93230-5787 | United States |
| UC Irvine Health /ID# 205728 | Irvine | California | 92697 | United States |
| Stanford MS Center /ID# 204283 | Palo Alto | California | 94304-1416 | United States |
| UC Davis Health-Neurological Surgery /ID# 204188 | Sacramento | California | 95817-2307 | United States |
| UCSF School of Medicine - Neurology /ID# 204251 | San Francisco | California | 94143-0003 | United States |
| University of Colorado School of Medicine /ID# 204250 | Aurora | Colorado | 80045-2527 | United States |
| Advanced Neurosciences Research, LLC /ID# 204289 | Fort Collins | Colorado | 80528 | United States |
| The University of Chicago Medical Center /ID# 205319 | Chicago | Illinois | 60637-1443 | United States |
| Indiana Univ School Medicine /ID# 204891 | Indianapolis | Indiana | 46202 | United States |
| Rowe Neurology Institute /ID# 204391 | Lenexa | Kansas | 66214 | United States |
| The NeuroMedical Center /ID# 204253 | Baton Rouge | Louisiana | 70810 | United States |
| Ochsner Medical Center /ID# 204189 | New Orleans | Louisiana | 70121-2429 | United States |
| Duplicate_Parexel International /ID# 204273 | Baltimore | Maryland | 21225 | United States |
| International Neurorehabilitation Institute /ID# 213332 | Lutherville | Maryland | 21093-6016 | United States |
| Pediatric Endocrine Associates /ID# 204279 | Boston | Massachusetts | 02114 | United States |
| Michigan Institute for Neurological Disorders (MIND) /ID# 204194 | Farmington Hills | Michigan | 48334 | United States |
| Memorial Neurological Institute and Center for Multiple Sclerosis /ID# 206328 | Owosso | Michigan | 48867-2116 | United States |
| Ridgeview Specialty Clinic Chaska - Neurology /ID# 204383 | Chaska | Minnesota | 55318-4551 | United States |
| Washington University-School of Medicine /ID# 204388 | St Louis | Missouri | 63110 | United States |
| The MS Center for Innovations in Care at Missouri Baptist Medical Center /ID# 205433 | St Louis | Missouri | 63131-2322 | United States |
| Cleveland Clinic Lou Ruvo Cent /ID# 204745 | Las Vegas | Nevada | 89106-0100 | United States |
| Oklahoma Med Res. Foundation /ID# 204389 | Oklahoma City | Oklahoma | 73104 | United States |
| Providence Neurological Specialties - West /ID# 204248 | Portland | Oregon | 97225-6646 | United States |
| Thomas Jefferson University /ID# 204281 | Philadelphia | Pennsylvania | 19107 | United States |
| Advanced Neurosciences Institute /ID# 204557 | Franklin | Tennessee | 37064 | United States |
| KCA Neurology - Franklin /ID# 204208 | Franklin | Tennessee | 37067-5914 | United States |
| Tri-State Mountain Neurology /ID# 204252 | Johnson City | Tennessee | 37604 | United States |
| Neurology Consultants of Dallas - LBJ Fwy /ID# 204398 | Dallas | Texas | 75243-1188 | United States |
| UT HSC Multiple Sclerosis Research Group - Houston /ID# 206418 | Houston | Texas | 77030-1501 | United States |
| Dr. Bhupesh Dihenia, MD, PA /ID# 207839 | Lubbock | Texas | 79410 | United States |
| Central Texas Neurology Consul /ID# 204268 | Round Rock | Texas | 78681 | United States |
| Integrated Neurology Services, PLLC /ID# 204261 | Alexandria | Virginia | 22310 | United States |
| Evergreen Neuroscience Institute /ID# 204203 | Kirkland | Washington | 98034-3029 | United States |
| Virginia Mason Medical Center /ID# 205440 | Seattle | Washington | 98101 | United States |
| Swedish MS Center /ID# 204198 | Seattle | Washington | 98122-5698 | United States |
| University of Washington Medicine MS Center /ID# 205852 | Seattle | Washington | 98133-8400 | United States |
| West Virginia Univ School Med /ID# 204292 | Morgantown | West Virginia | 26506 | United States |
| Froedtert Memorial Lutheran Hospital /ID# 204202 | Milwaukee | Wisconsin | 53226-3522 | United States |
| University of British Columbia - MS & NMO Clinical Trials Group, Djavad Mowafagh /ID# 204841 | Vancouver | British Columbia | V6T 1Z3 | Canada |
| Duplicate_London Health Sciences Centre - University Hospital /ID# 204848 | London | Ontario | N6A 5A5 | Canada |
| Ottawa Hospital Research Institute /ID# 204842 | Ottawa | Ontario | K1H 8L6 | Canada |
| Unity Health Toronto - St. Michael's Hospital /ID# 206214 | Toronto | Ontario | M5B 1W8 | Canada |
| Recherche Sepmus Inc. /ID# 212851 | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Centre Hospitalier de l'Universite de Montreal - CRCHUM /ID# 204844 | Montreal | Quebec | H2X 0A9 | Canada |
| Montreal Neurological Institut /ID# 204843 | Montreal | Quebec | H3A 2B4 | Canada |
| FG002 | Elezanumab Dose 2 | Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion. elezanumab: solution for infusion |
| COMPLETED |
|
| NOT COMPLETED |
|
The Modified Intent-to-Treat (mITT) Analysis Set consists of all randomized subjects who received at least 1 dose of study drug. Subjects were grouped according to treatment as randomized.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants randomized to receive double-blind placebo by intravenous infusion. placebo: solution for infusion |
| BG001 | Elezanumab Dose 1 | Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion. elezanumab: solution for infusion |
| BG002 | Elezanumab Dose 2 | Participants randomized to receive double-blind elezanumab Dose 2 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/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Type of Multiple Sclerosis (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) at Week 52 | 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. Subjects were grouped according to treatment as randomized. | 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 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. Subjects were grouped according to treatment as randomized. | 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). 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. Subjects were grouped according to treatment as randomized. | 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. Subjects were grouped according to treatment as randomized. | 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. Subjects were grouped according to treatment as randomized. | Posted | Mean | Standard Deviation | 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 double-blind placebo by intravenous infusion. placebo: solution for infusion | 1 | 70 | 6 | 70 | 52 | 70 |
| EG001 | Elezanumab Dose 1 | Participants randomized to receive double-blind elezanumab Dose 1 by intravenous infusion. elezanumab: solution for infusion | 0 | 69 | 7 | 69 | 48 | 69 |
| EG002 | Elezanumab Dose 2 | Participants randomized to receive double-blind elezanumab Dose 2 by intravenous infusion. elezanumab: solution for infusion | 0 | 69 | 4 | 69 | 54 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIVERTICULUM INTESTINAL | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| UMBILICAL HERNIA | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ASTHENIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 PNEUMONIA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| FRACTURE DISPLACEMENT | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| SKULL FRACTURED BASE | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| MYOCARDIAL STRAIN | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| HYPONATRAEMIA | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MYELOPATHY | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| SEIZURE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| TRIGEMINAL NEURALGIA | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| UHTHOFF'S PHENOMENON | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 24.0 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DEEP VEIN THROMBOSIS | Vascular 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 |
| |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 24.0 | Systematic Assessment |
| |
| DIARRHOEA | 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 |
| |
| FATIGUE | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| PAIN | General disorders | MedDRA 24.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 24.0 | Systematic Assessment |
| |
| SINUSITIS | 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 |
| |
| FALL | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
| |
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 24.0 | Systematic Assessment |
| |
| ARTHRALGIA | 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 |
| |
| DIZZINESS | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| MIGRAINE | 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 |
| |
| ANXIETY | Psychiatric disorders | MedDRA 24.0 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric 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 | 800-633-9110 | 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 |
| 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 |
|---|---|
| C000723102 | elezanumab |
Not provided
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Non-White |
|
| Missing |
|
| United States |
|
| relapsing secondary-progressive MS (rSPMS) |
|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|