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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-501332-42 | Other Identifier | EU CTR | |
| U1111-1281-5433 | Other Identifier | WHO |
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The purpose of this study is to evaluate the effectiveness, safety, tolerability, drug levels and drug effects of ozanimod compared to fingolimod in children and adolescents with relapsing remitting multiple sclerosis (RRMS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ozanimod | Experimental |
| |
| Fingolimod | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | Specified dose on specified days |
| |
| Fingolimod |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized relapse rate (ARR) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who did not have a confirmed relapse | At 12 and 24 months | |
| Number of gadolinium enhancing (GdE) T1 lesions | At month 6 and month 12 | |
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Inclusion Criteria:
Has a diagnosis of multiple sclerosis (MS) as defined by the 2017 revision of the McDonald Criteria with a relapsing remitting course of disease.
Meets at least 1 of the following criteria for disease activity:
i) At least 1 MS relapse/attack in the previous year prior to screening.
ii) At least 2 MS relapses/attacks in the previous 2 years prior to screening.
iii) Evidence of 1 or more gadolinium-enhancing (GdE) lesions on magnetic resonance imaging (MRI) within 6 months prior to baseline (including screening MRI).
- Has an Expanded Disability Status Scale (EDSS) score of 0 to 5.5, both inclusive.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0114 | Not yet recruiting | Loma Linda | California | 92354 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Drug |
Specified dose on specified days |
|
| Placebo | Other | Specified dose on specified days |
|
| Number of new or newly enlarging hyperintense lesions on T2 magnetic resonance imaging (MRI) sequences |
| At 6, 12, 18, and 24 months |
| Incidence of treatment-emergent adverse events (TEAEs) over the treatment period and over the post-treatment follow-up period | Up to 87 months |
| Incidence of adverse event of special interests (AESIs) over the treatment period and over the post-treatment follow-up period | Up to 87 months |
| Adverse events (AEs) leading to discontinuation over the treatment period and over the post-treatment follow-up period | Up to 87 months |
| Steady state plasma concentrations of ozanimod | At day 90 |
| Steady state plasma concentrations of the primary active metabolite CC112273 | At day 90 |
| Change from baseline pharmacodynamics (PD) biomarkers of absolute lymphocyte count | At day 90 and throughout the study up to 24 months |
| University of California Davis Health | Recruiting | Sacramento | California | 95817 | United States |
|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
|
| Local Institution - 0093 | Withdrawn | Chicago | Illinois | 60611 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Louisville, Norton Children's Research Institute | Recruiting | Louisville | Kentucky | 40202 | United States |
|
| Local Institution - 0131 | Not yet recruiting | New Brunswick | New Jersey | 08901 | United States |
|
| Local Institution - 0132 | Withdrawn | Teaneck | New Jersey | 07666 | United States |
| Local Institution - 0091 | Withdrawn | Cincinnati | Ohio | 45229 | United States |
| Local Institution - 0092 | Not yet recruiting | Portland | Oregon | 97225 | United States |
|
| Local Institution - 0133 | Not yet recruiting | El Paso | Texas | 79912 | United States |
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| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| Royal Children's Hospital | Recruiting | Melbourne | Victoria | 3052 | Australia |
|
| University of Naples Federico II | Recruiting | Naples | Campania | 80131 | Italy |
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| Ospedale San Raffaele | Recruiting | Milan | Lombardy | 20132 | Italy |
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| Local Institution - 0081 | Not yet recruiting | Milan | Lombardy | 20133 | Italy |
|
| Neurological Center Of Latium | Recruiting | Rome | Roma | 00178 | Italy |
|
| Local Institution - 0078 | Withdrawn | Mexico City | DIF | 04530 | Mexico |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Recruiting | Poznan | Greater Poland Voivodeship | 60-355 | Poland |
|
| 2Ca Braga | Recruiting | Braga | 4710-243 | Portugal |
|
| Unidade Local de Saúde de Coimbra, E.P.E. | Recruiting | Coimbra | 3000-602 | Portugal |
|
| Centro Hospitalar de Lisboa Central | Recruiting | Lisbon | 1169-050 | Portugal |
|
| Local Institution - 0102 | Withdrawn | Porto | 4200-319 | Portugal |
| Local Institution - 0134 | Not yet recruiting | Caguas | 00725 | Puerto Rico |
|
| Spitalul Clinic de Copii Doctor Victor Gomoiu | Recruiting | Bucharest | Bucharest | 022102 | Romania |
|
| Prof. Dr. Alexandru Obregia Psychiatry Hospital | Recruiting | Bucharest | Bucharest | 041914 | Romania |
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| Local Institution - 0096 | Not yet recruiting | Esplugues de Llobregat | Barcelona [Barcelona] | 08950 | Spain |
|
| CHUVI- Hospital Alvaro Cunqueiro | Recruiting | Vigo | Pontevedra [Pontevedra] | 36203 | Spain |
|
| Hospital Universitario Virgen Macarena | Recruiting | Seville | 41009 | Spain |
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| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
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| Hospital Universitario Miguel Servet | Recruiting | Zaragoza | 50009 | Spain |
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| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
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| Ondokuz Mayıs Universitesi | Recruiting | Samsun | 55270 | Turkey (Türkiye) |
|
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| 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 |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
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