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| Name | Class |
|---|---|
| Merck KGaA, Darmstadt, Germany | INDUSTRY |
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To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion Disease-Modifying Drugs (DMDs) approved in the United States (US) for RMS in a real-world-setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cladribine Tablets | No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any oral or infusion DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI). Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cladribine Tablets | Drug | No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Relapse Rate (ARR) | A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. | From first dose of cladribine tablets up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM has 14 questions that assesses participants' global satisfaction level with their treatment in 4 domains: side effects (There are 5 questions in the side effects domain, however one of them is a Yes/No question and there are 4 sub-components, hence a maximum score of 20), effectiveness (3 questions), global satisfaction (3 questions), and convenience (3 questions). All questions are scored from 1 (least satisfied) to 5 or 7 (most satisfied). The total score is summed for each domain to obtain: side effects (1-20), effectiveness (1-21), global satisfaction (1-17), and convenience (1-21), using transformed scores between 0 and 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Central Neurology Associates, P.C. | Cullman | Alabama | 35058 | United States | ||
| University of South Alabama |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33517769 | Derived | Miravalle AA, Katz J, Robertson D, Hayward B, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJ. CLICK-MS and MASTER-2 Phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis. Neurodegener Dis Manag. 2021 Apr;11(2):99-111. doi: 10.2217/nmt-2020-0059. Epub 2021 Feb 1. |
| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cladribine Tablets: Switch From Oral | Participants who had decided prior to enrollment to transition from any oral Disease-Modifying Drug (DMD) to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
| 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 | Oct 21, 2024 | Nov 11, 2025 |
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| Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | The SF-36 Health Survey is a validated, self-administered questionnaire designed to assess general health status across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It includes one item evaluating perceived change in health over the past year and generates two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-derived using factor analytic methods. Each domain and summary score is scaled from 0 to 100, with higher scores indicating better health status. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | The MFIS-5 is a shortened version of the Fatigue Impact Scale consisting of 5 items that assess the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale: 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Often), and 4 (Almost always). The total score ranges from 0 to 20, with higher scores indicating a greater impact of fatigue. Items include: reduced alertness, limitations in activities away from home, difficulty sustaining physical effort, reduced ability to complete tasks requiring physical effort, and trouble concentrating. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | The 7-item Beck Depression Inventory-Fast Screen (BDI-FS) is a self-report tool used to assess the severity of depressive symptoms. It includes seven items: Sadness, Pessimism, Past Failure, Loss of Pleasure, Self-Dislike, Self-Criticalness, and Suicidal Thoughts. Each item is rated on a 4-point scale from 0 to 3, with higher scores indicating greater symptom severity. The total score ranges from 0 to 21 and is calculated by summing the highest-rated response for each item. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of work time missed (absenteeism) was reported. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of impairment while working (presentisms) was reported. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in total percentage of work impairment (absenteeism and presentisms) were reported. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of activity impairment was reported. | Baseline (Month 0), Month 6, 12 and 24 |
| Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | The PDDS is a patient-reported scale to assess the disability status in participants with MS, and it focuses mainly on how participants walk. Scores on the PDDS range from 0 (normal) to 8 (bedridden): 0 (Normal), 1 (Mild Disability), 2 (Moderate Disability), 3 (Gait Disability), 4 (Early Cane), 5 (Late Cane), 6 (Bilateral Support), 7 (Wheelchair/Scooter), and 8 (Bedridden). A higher score represents higher level of disability. | Baseline (Month 0), Month 6, 12 and 24 |
| Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | 7 Treatment adherence questions, based on MS-TAQ, were developed to determine level of adherence as well as identify barriers to adherence for MS participants taking DMDs. 1.What treatment week of cladribine (Clad.) tablets (tab.) did you most recently complete? 2.How many Clad. tab. were you supposed to take during this treatment week? 3.Did you miss/forget to take any Clad. tab. during this treatment week? 4. How many Clad. tab. did you miss/ forget to take? 5.How important were following factors in missing/forgetting to take a dose? (scale from 0-3, where, 0=Not important at all and 3=Extremely important). 6.Overall, how hard/easy do you feel it is to take Clad. tab. as recommended by your physician during your treatment week? (scale from 1- 5, where 1=Extremely easy and 5=Extremely hard). 7.How satisfied are you with how things have been with your Clad. tab. treatment during your treatment week? (scale from 1-5, where 1=Not satisfied at all and 5=Completely satisfied). | Month 1, 2, 13 and 14 |
| Number of Participants Who Experienced Relapse | A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. | Over the 12-month and 24-month period |
| Percentage of Participants With Relapse Associated With Hospitalization | A relapse was defined according to routine clinical practice as determined by the investigator. A relapse will be associated with hospitalization if the participants will be hospitalized for the relapse. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants who experienced a relapse associated with hospitalization was reported. | Over the 12-month period, 13th to 24th month and over the 24 month period. |
| Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than [>] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to [>=] 30 days).ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. ARR associated with hospitalization at Months 12 and 24 were reported. A relapse was associated with hospitalization if the participant will be hospitalized for the relapse. | Month 12 and Month 24 |
| Percentage of Participants With Relapse Associated With Glucocorticoid Use | A relapse was defined according to routine clinical practice as determined by the investigator. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants with relapse associated with glucocorticoid use over the 12-month period, 13th to 24th month and over the 24-month period of treatment with cladribine tablets was reported. | Over the 12-month period, 13th to 24th month and over the 24 month period. |
| Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than [>] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to [>=] 30 days). ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. ARR associated with glucocorticoid use at Months 12 and 24 were reported. A relapse will be associated with glucocorticoid use if steroid treatment will be required for the relapse. | Months 12 and 24 |
| Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | Number of previous DMD received by participants with MS were reported. | At Baseline (Month 0) |
| Percentage of Participants Who Discontinued Cladribine Tablets | Percentage of participants who discontinued cladribine tablets were reported. | Baseline (Month 0) up to 24 Months |
| Number of Participants With Reason for Discontinuation of Cladribine Tablets | Number of participants who discontinued cladribine tablets in each category of reason for discontinuation were reported. | Baseline (Month 0) up to 24 Months |
| Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | Elapsed time to discontinuation after first dose of cladribine tablets was reported. Elapsed time to discontinuation of cladribine tablets is calculated by subtracting the date of the first study dose from the date on which the participant discontinued cladribine tablets. | Baseline (Month 0) up to 24 Months |
| Number of Doses Received by Participants as Per United States Prescribing Information | Number of doses received by participants as per United States prescribing information were reported. | Baseline (Month 0) up to 24 Months |
| Total Planned Doses Received by Participants as Per United States Prescribing Information | Total planned doses received by participants as per United States Prescribing Information was reported. | Baseline (Month 0) up to 24 Months |
| Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets | Percentage of participants with subsequent treatment chosen following discontinuation of cladribine tablets was reported. The percentages were calculated using the number of participants who discontinued Cladribine tablets as denominator. | Baseline (Month 0) up to 24 Months |
| Number of Participants With At Least One Concomitant Medication | Number of participants with at least one concomitant medication were reported. | Baseline (Month 0) up to 24 Months |
| Annualized Relapse Rate (ARR) | A relapse was defined as an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. Annualized relapse rate (ARR) during the 24 months prior to baseline, based on retrospectively collected data, was reported. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. | Up to 24 Months prior Baseline (Month 0) |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. Special Situations included AEs related to pregnancy, overdose, off-label use, misuse, medication error, occupational exposure, or lack of therapeutic effectiveness. | Baseline (Month 0) up to 24 months |
| Mobile |
| Alabama |
| 36693 |
| United States |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| Fullerton Neurology and Headache Center | Fullerton | California | 92835 | United States |
| Regina Berkovich MD PhD INC | West Hollywood | California | 90048 | United States |
| Colorado Springs Neurological Associates, PC - Neurology | Colorado Springs | Colorado | 80907 | United States |
| HCA Research Institute | Englewood | Colorado | 80113 | United States |
| Advanced Neurosciences Research, LLC | Fort Collins | Colorado | 80528 | United States |
| Associated Neurologists of Southern Connecticut, PC | Fairfield | Connecticut | 06824 | United States |
| Yale University | Fairfield | Connecticut | 06824 | United States |
| Neurology Associates, P. A. | Maitland | Florida | 32751 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Orlando Health Multiple Sclerosis Comprehensive Care Center - Downtown Orlando | Orlando | Florida | 32806 | United States |
| Suncoast Neuroscience and Associates, Inc. | St. Petersburg | Florida | 33713 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| University of South Florida | Tampa | Florida | 33612 | United States |
| Northwest Neurology Ltd | Rolling Meadows | Illinois | 60008 | United States |
| Prairie Education & Research | Springfield | Illinois | 62702 | United States |
| Fort Wayne Neurological Center | Fort Wayne | Indiana | 46804 | United States |
| College Park Family Care Center | Overland Park | Kansas | 66212 | United States |
| Baptist Health Lexington | Lexington | Kentucky | 40503 | United States |
| Northern Light Comprehensive Multiple Sclerosis Care Center | Bangor | Maine | 04401 | United States |
| Neurological Clinical Research Institute | Boston | Massachusetts | 02114 | United States |
| Neuro Institute of New England P.C. | Foxborough | Massachusetts | 02035 | United States |
| The Elliot Lewis Center for Multiple Sclerosis Care | Wellesley | Massachusetts | 02481 | United States |
| UMASS - Neurology | Worcester | Massachusetts | 01655 | United States |
| Wayne State University (WSU) - Multiple Sclerosis Treatment and Clinical Research Center (MS Center) - Department of Neurology | Detroit | Michigan | 48201 | United States |
| Detroit Clinical Research Center, PC | Farmington Hills | Michigan | 48334 | United States |
| Memorial Healthcare | Owosso | Michigan | 48867 | United States |
| Minneapolis Clinic of Neurology - Neurology | Golden Valley | Minnesota | 55422 | United States |
| Neurology Center of Las Vegas | Las Vegas | Nevada | 89128 | United States |
| DENT Neurologic Institute | Amherst | New York | 14226 | United States |
| NYU Langone Brooklyn - Brooklyn | Brooklyn | New York | 11220 | United States |
| The Trustee of Columbia University in the City of New York | New York | New York | 10032 | United States |
| The Charlotte-Mecklenburg Hospital Authority - Carolinas Healthcare System | Charlotte | North Carolina | 28203 | United States |
| Guilford Neurologic Associates | Greensboro | North Carolina | 27405 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6010 | United States |
| Insight Neuroscience LLC | Bellevue | Ohio | 44811 | United States |
| Riverhills Neuroscience | Cincinnati | Ohio | 45212 | United States |
| The Boster Center for Multiple Scelosis | Columbus | Ohio | 43235 | United States |
| Dayton Center for Neurological Disorders | Dayton | Ohio | 45459 | United States |
| University of Toledo - PARENT | Toledo | Ohio | 43614-2598 | United States |
| Providence Neurological Specialties | Portland | Oregon | 97225 | United States |
| Wills Eye Institute - Ocular Oncology Service - Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Premier Neurology Research, P.C. | Greer | South Carolina | 29650 | United States |
| Neurology, PC | Knoxville | Tennessee | 37922 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Northwest Houston Neurology | Cypress | Texas | 77429 | United States |
| Baylor College of Medicine IRB | Houston | Texas | 77030 | United States |
| DHR Health Neurology Institute Neuroimmunology and Multiple Sclerosis | McAllen | Texas | 78503 | United States |
| Central Texas Neurology Consultants | Round Rock | Texas | 78681 | United States |
| Neurology Center of San Antonio | San Antonio | Texas | 78258 | United States |
| Integrated Neurology Services - Dr. Simon Fishman's Office | Alexandria | Virginia | 22310 | United States |
| Blacksburg Neurology, PC | Christiansburg | Virginia | 24073 | United States |
| Meridian Clinical Research (Neurology) | Norfolk | Virginia | 23502 | United States |
| Neurological Associates | Richmond | Virginia | 23226 | United States |
| VCU Medical Center - Pediatric Neurology | Richmond | Virginia | 23298-0211 | United States |
| Massey Cancer Center - VCU Medical Center | Richmond | Virginia | 23298 | United States |
| Multiple Sclerosis Center of Greater Washington | Vienna | Virginia | 22182 | United States |
| Sentara Ambulatory Care Center | Virginia Beach | Virginia | 23456 | United States |
| MS Center of Evergreen | Kirkland | Washington | 98034 | United States |
| MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research and | Spokane | Washington | 99202 | United States |
| MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research | Tacoma | Washington | 98405 | United States |
| Ascension St. Francis Center for Neurological Disorders, S.C. | Milwaukee | Wisconsin | 53215 | United States |
| The Medical College of Wisconsin - Endocrinology | Milwaukee | Wisconsin | 53226 | United States |
| Neuroscience Group of Northeast Wisconsin - DUPLICATE | Neenah | Wisconsin | 54956 | United States |
| US Medical Information website, Medical Resources | View source |
| FG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
| Participants Who Received at Least 1 Dose of Cladribine Tablets |
|
| Switch From Ocrelizumab | Participants who switched from infusion DMD (ocrelizumab) to CladT |
|
| COMPLETED |
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| NOT COMPLETED |
|
|
FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cladribine Tablets: Switch From Oral | Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
| BG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
| 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM has 14 questions that assesses participants' global satisfaction level with their treatment in 4 domains: side effects (There are 5 questions in the side effects domain, however one of them is a Yes/No question and there are 4 sub-components, hence a maximum score of 20), effectiveness (3 questions), global satisfaction (3 questions), and convenience (3 questions). All questions are scored from 1 (least satisfied) to 5 or 7 (most satisfied). The total score is summed for each domain to obtain: side effects (1-20), effectiveness (1-21), global satisfaction (1-17), and convenience (1-21), using transformed scores between 0 and 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | The SF-36 Health Survey is a validated, self-administered questionnaire designed to assess general health status across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It includes one item evaluating perceived change in health over the past year and generates two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-derived using factor analytic methods. Each domain and summary score is scaled from 0 to 100, with higher scores indicating better health status. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | The MFIS-5 is a shortened version of the Fatigue Impact Scale consisting of 5 items that assess the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale: 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Often), and 4 (Almost always). The total score ranges from 0 to 20, with higher scores indicating a greater impact of fatigue. Items include: reduced alertness, limitations in activities away from home, difficulty sustaining physical effort, reduced ability to complete tasks requiring physical effort, and trouble concentrating. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | The 7-item Beck Depression Inventory-Fast Screen (BDI-FS) is a self-report tool used to assess the severity of depressive symptoms. It includes seven items: Sadness, Pessimism, Past Failure, Loss of Pleasure, Self-Dislike, Self-Criticalness, and Suicidal Thoughts. Each item is rated on a 4-point scale from 0 to 3, with higher scores indicating greater symptom severity. The total score ranges from 0 to 21 and is calculated by summing the highest-rated response for each item. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of work time missed (absenteeism) was reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | percentage of work time missed | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of impairment while working (presentisms) was reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | percentage of impairment while working | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in total percentage of work impairment (absenteeism and presentisms) were reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | percentage of overall work impairment | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 | The WPAI-MS questionnaire is a 6-item validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of activity impairment was reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | percentage of activity impairment | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | The PDDS is a patient-reported scale to assess the disability status in participants with MS, and it focuses mainly on how participants walk. Scores on the PDDS range from 0 (normal) to 8 (bedridden): 0 (Normal), 1 (Mild Disability), 2 (Moderate Disability), 3 (Gait Disability), 4 (Early Cane), 5 (Late Cane), 6 (Bilateral Support), 7 (Wheelchair/Scooter), and 8 (Bedridden). A higher score represents higher level of disability. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Month 0), Month 6, 12 and 24 |
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| Secondary | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | 7 Treatment adherence questions, based on MS-TAQ, were developed to determine level of adherence as well as identify barriers to adherence for MS participants taking DMDs. 1.What treatment week of cladribine (Clad.) tablets (tab.) did you most recently complete? 2.How many Clad. tab. were you supposed to take during this treatment week? 3.Did you miss/forget to take any Clad. tab. during this treatment week? 4. How many Clad. tab. did you miss/ forget to take? 5.How important were following factors in missing/forgetting to take a dose? (scale from 0-3, where, 0=Not important at all and 3=Extremely important). 6.Overall, how hard/easy do you feel it is to take Clad. tab. as recommended by your physician during your treatment week? (scale from 1- 5, where 1=Extremely easy and 5=Extremely hard). 7.How satisfied are you with how things have been with your Clad. tab. treatment during your treatment week? (scale from 1-5, where 1=Not satisfied at all and 5=Completely satisfied). | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure, while "number analyzed" refers to those evaluable at specific timepoints. | Posted | Count of Participants | Participants | Month 1, 2, 13 and 14 |
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| Secondary | Number of Participants Who Experienced Relapse | A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Count of Participants | Participants | Over the 12-month and 24-month period |
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| Secondary | Percentage of Participants With Relapse Associated With Hospitalization | A relapse was defined according to routine clinical practice as determined by the investigator. A relapse will be associated with hospitalization if the participants will be hospitalized for the relapse. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants who experienced a relapse associated with hospitalization was reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Number | percentage of participants | Over the 12-month period, 13th to 24th month and over the 24 month period. |
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| Secondary | Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than [>] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to [>=] 30 days).ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. ARR associated with hospitalization at Months 12 and 24 were reported. A relapse was associated with hospitalization if the participant will be hospitalized for the relapse. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, "overall Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at each specified timepoints. | Posted | Mean | Standard Deviation | relapses per year | Month 12 and Month 24 |
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| Secondary | Percentage of Participants With Relapse Associated With Glucocorticoid Use | A relapse was defined according to routine clinical practice as determined by the investigator. As a guide, relapse was considered an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. The percentage of participants with relapse associated with glucocorticoid use over the 12-month period, 13th to 24th month and over the 24-month period of treatment with cladribine tablets was reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, "overall Number of participants analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at each specified timepoints. | Posted | Number | percentage of participants | Over the 12-month period, 13th to 24th month and over the 24 month period. |
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| Secondary | Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than [>] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to [>=] 30 days). ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. ARR associated with glucocorticoid use at Months 12 and 24 were reported. A relapse will be associated with glucocorticoid use if steroid treatment will be required for the relapse. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Mean | Standard Deviation | relapses per year | Months 12 and 24 |
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| Secondary | Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | Number of previous DMD received by participants with MS were reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Mean | Standard Deviation | number of DMDs received | At Baseline (Month 0) |
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| Secondary | Percentage of Participants Who Discontinued Cladribine Tablets | Percentage of participants who discontinued cladribine tablets were reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Number | percentage of participants | Baseline (Month 0) up to 24 Months |
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| Secondary | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Number of participants who discontinued cladribine tablets in each category of reason for discontinuation were reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Count of Participants | Participants | Baseline (Month 0) up to 24 Months |
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| Secondary | Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | Elapsed time to discontinuation after first dose of cladribine tablets was reported. Elapsed time to discontinuation of cladribine tablets is calculated by subtracting the date of the first study dose from the date on which the participant discontinued cladribine tablets. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. "Overall number of participants analyzed" refers to those evaluable for the outcome measure. | Posted | Median | Full Range | months | Baseline (Month 0) up to 24 Months |
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| Secondary | Number of Doses Received by Participants as Per United States Prescribing Information | Number of doses received by participants as per United States prescribing information were reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Median | Full Range | number of doses received | Baseline (Month 0) up to 24 Months |
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| Secondary | Total Planned Doses Received by Participants as Per United States Prescribing Information | Total planned doses received by participants as per United States Prescribing Information was reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Median | Full Range | mg/kg | Baseline (Month 0) up to 24 Months |
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| Secondary | Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets | Percentage of participants with subsequent treatment chosen following discontinuation of cladribine tablets was reported. The percentages were calculated using the number of participants who discontinued Cladribine tablets as denominator. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Number | percentage of participants | Baseline (Month 0) up to 24 Months |
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| Secondary | Number of Participants With At Least One Concomitant Medication | Number of participants with at least one concomitant medication were reported. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Count of Participants | Participants | Baseline (Month 0) up to 24 Months |
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| Secondary | Annualized Relapse Rate (ARR) | A relapse was defined as an exacerbation of symptoms that occurred over a minimum of 24 hours and was separated from a previous attack by at least 30 days, in the absence of fever or infection. Annualized relapse rate (ARR) during the 24 months prior to baseline, based on retrospectively collected data, was reported. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Mean | Standard Deviation | relapses per year | Up to 24 Months prior Baseline (Month 0) |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate. Special Situations included AEs related to pregnancy, overdose, off-label use, misuse, medication error, occupational exposure, or lack of therapeutic effectiveness. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Count of Participants | Participants | Baseline (Month 0) up to 24 months |
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| Primary | Annualized Relapse Rate (ARR) | A relapse was defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. | Posted | Mean | Standard Deviation | relapses per year | From first dose of cladribine tablets up to 24 months |
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Baseline (Month 0) up to 24 months
Not provided
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 | Cladribine Tablets: Switch From Oral | Participants who had decided prior to enrollment to transition from any oral DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. | 2 | 103 | 10 | 103 | 65 | 103 |
| EG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. | 0 | 85 | 14 | 85 | 51 | 85 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ureteritis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Breast cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Psychogenic seizure | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abortion threatened | Pregnancy, puerperium and perinatal conditions | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Type V hyperlipidaemia | Congenital, familial and genetic disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Blindness unilateral | Eye disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vitreous opacities | Eye disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Anal incontinence | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hepatic steatosis | Hepatobiliary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Coronavirus infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| External ear cellulitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Helicobacter infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Oral fungal infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Respiratory syncytial virus infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Blood cholesterol increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vitamin B12 deficiency | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Joint lock | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Altered state of consciousness | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Facial spasm | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Multiple sclerosis relapse | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Post herpetic neuralgia | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Radial nerve palsy | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Sensory disturbance | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Abnormal dreams | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Bladder hypertrophy | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Incontinence | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urethral polyp | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Nipple pain | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Penile discharge | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Perineal pain | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Essential hypertension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Peripheral venous disease | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 27.1 | Non-systematic Assessment |
| |
| Subclavian artery stenosis | Vascular disorders | MedDRA Version 27.1 | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA,Darmstadt, Germany | 6151725200 | +49 | service@emdgroup.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 23, 2025 | Nov 11, 2025 | SAP_001.pdf |
| 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 |
|---|---|
| D017338 | Cladribine |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
Not provided
Not provided
| 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 |
|
| Global Satisfaction: Month 12 |
|
|
| Global Satisfaction: Month 24 |
|
|
| Effectiveness: Month 6 |
|
|
| Effectiveness: Month 12 |
|
|
| Effectiveness: Month 24 |
|
|
| Side Effects: Month 6 |
|
|
| Side Effects: Month 12 |
|
|
| Side Effects: Month 24 |
|
|
| Convenience: Month 6 |
|
|
| Convenience: Month 12 |
|
|
| Convenience: Month 24 |
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
| Cladribine Tablets: Switch From Infusion |
Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study.
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
|
|
|
|
| OG001 | Cladribine Tablets: Switch From Infusion | Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
| Cladribine Tablets: Switch From Infusion |
Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 |
| Cladribine Tablets: Switch From Infusion |
Participants who had decided prior to enrollment to transition from any infusion DMD to treatment with cladribine tablets under routine clinical care and who met all eligibility criteria received an initial treatment course with cladribine tablets in Year 1 and a second course in Year 2, as per the approved United States Prescribing Information (USPI). No intervention was administered as a part of this study and all data was prospectively collected during this study. |
|
|
|
|