Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Cladribine Tablets, Observational, Mavenclad
Brief summary
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.
Interventions
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.
Sponsors
Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI) * Have time since diagnosis of RMS of at least 12 months * In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets * Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD * Have decided to initiate treatment with cladribine tablets during routine clinical care * Meet criteria as per the approved USPI * Have access to a valid e-mail address
Exclusion criteria
* Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral) * Transitioning from previous oral DMD solely for administrative reasons such as relocation * Have comorbid conditions that preclude participation * Have any clinical condition or medical history noted as contraindication on USPI * Are currently participating in an interventional clinical trial * Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Annualized Relapse Rate (ARR) | From first dose of cladribine tablets up to 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | Baseline (Month 0), 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. |
| Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Baseline (Month 0), 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. |
| Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Baseline (Month 0), 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. |
| 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 | Baseline (Month 0), 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. |
| 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 | Baseline (Month 0), 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. |
| 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 | Baseline (Month 0), 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. |
| 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 | Baseline (Month 0), 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. |
| Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Baseline (Month 0), 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. |
| Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 1, 2, 13 and 14 | 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). |
| Number of Participants Who Experienced Relapse | Over the 12-month and 24-month period | 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. |
| Percentage of Participants With Relapse Associated With Hospitalization | Over the 12-month period, 13th to 24th month and over the 24 month period. | 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. |
| Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | Month 12 and Month 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. |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Baseline (Month 0), 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. |
| Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | 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. |
| Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | At Baseline (Month 0) | Number of previous DMD received by participants with MS were reported. |
| Percentage of Participants Who Discontinued Cladribine Tablets | Baseline (Month 0) up to 24 Months | Percentage of participants who discontinued cladribine tablets were reported. |
| Number of Participants With Reason for Discontinuation of Cladribine Tablets | Baseline (Month 0) up to 24 Months | Number of participants who discontinued cladribine tablets in each category of reason for discontinuation were reported. |
| Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | Baseline (Month 0) up to 24 Months | 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. |
| Number of Doses Received by Participants as Per United States Prescribing Information | Baseline (Month 0) up to 24 Months | Number of doses received by participants as per United States prescribing information were reported. |
| Total Planned Doses Received by Participants as Per United States Prescribing Information | Baseline (Month 0) up to 24 Months | Total planned doses received by participants as per United States Prescribing Information was reported. |
| Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets | Baseline (Month 0) up to 24 Months | 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. |
| Number of Participants With At Least One Concomitant Medication | Baseline (Month 0) up to 24 Months | Number of participants with at least one concomitant medication were reported. |
| Annualized Relapse Rate (ARR) | Up to 24 Months prior Baseline (Month 0) | 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. |
| Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | Baseline (Month 0) up to 24 months | 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. |
| Percentage of Participants With Relapse Associated With Glucocorticoid Use | Over the 12-month period, 13th to 24th month and over the 24 month period. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 103 |
| 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. | 85 |
| Total | 188 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 |
| Overall Study | Death | 2 | 0 |
| Overall Study | Discontinuation due to safety extension removal by Sponsor | 0 | 1 |
| Overall Study | Investigator decision | 4 | 0 |
| Overall Study | Lost to Follow-up | 16 | 8 |
| Overall Study | Missed visit | 0 | 1 |
| Overall Study | Participant changed primary neurology provider | 1 | 0 |
| Overall Study | Participant could not be entered as a follow-up | 0 | 1 |
| Overall Study | Participant delayed year 2 due to subject fear of COVID-19 | 1 | 0 |
| Overall Study | Participant discontinuation due to Sponsor decision to close study | 0 | 2 |
| Overall Study | Participant non-compliant, therefore, has been discontinued | 1 | 0 |
| Overall Study | Participant transferred care | 1 | 0 |
| Overall Study | Participant withdrawn by Principal Investigator | 1 | 0 |
| Overall Study | Progressive disease | 0 | 3 |
| Overall Study | Protocol non-compliance | 6 | 3 |
| Overall Study | Site closed prematurely due to unexpected circumstances | 0 | 1 |
| Overall Study | Site research department closing | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 8 |
Baseline characteristics
| Characteristic | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion | Total |
|---|---|---|---|
| Age, Continuous | 50 years STANDARD_DEVIATION 10.8 | 48 years STANDARD_DEVIATION 12.5 | 49 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants | 74 Participants | 167 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants | 6 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Race (NIH/OMB) White | 85 Participants | 68 Participants | 153 Participants |
| Sex: Female, Male Female | 84 Participants | 58 Participants | 142 Participants |
| Sex: Female, Male Male | 19 Participants | 27 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 103 | 0 / 85 |
| other Total, other adverse events | 65 / 103 | 51 / 85 |
| serious Total, serious adverse events | 10 / 103 | 14 / 85 |
Outcome results
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.
Time frame: From first dose of cladribine tablets up to 24 months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Annualized Relapse Rate (ARR) | 0.04 relapses per year | Standard Deviation 0.145 |
| Cladribine Tablets: Switch From Infusion | Annualized Relapse Rate (ARR) | 0.03 relapses per year | Standard Deviation 0.153 |
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.
Time frame: Up to 24 Months prior Baseline (Month 0)
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Annualized Relapse Rate (ARR) | 0.17 relapses per year | Standard Deviation 0.313 |
| Cladribine Tablets: Switch From Infusion | Annualized Relapse Rate (ARR) | 0.14 relapses per year | Standard Deviation 0.268 |
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.
Time frame: Months 12 and 24
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | Month 12 | 0.01 relapses per year | Standard Deviation 0.114 |
| Cladribine Tablets: Switch From Oral | Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | Month 24 | 0.02 relapses per year | Standard Deviation 0.093 |
| Cladribine Tablets: Switch From Infusion | Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | Month 12 | 0.04 relapses per year | Standard Deviation 0.201 |
| Cladribine Tablets: Switch From Infusion | Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 | Month 24 | 0.03 relapses per year | Standard Deviation 0.142 |
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.
Time frame: Month 12 and Month 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | Month 12 | 0.01 relapses per year | Standard Deviation 0.114 |
| Cladribine Tablets: Switch From Oral | Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | Month 24 | 0.01 relapses per year | Standard Deviation 0.057 |
| Cladribine Tablets: Switch From Infusion | Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | Month 12 | 0.00 relapses per year | Standard Deviation 0 |
| Cladribine Tablets: Switch From Infusion | Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 | Month 24 | 0.00 relapses per year | Standard Deviation 0 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Side Effects: Month 6 | 11.4 units on a scale | Standard Deviation 40.28 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Global Satisfaction: Month 24 | 16.1 units on a scale | Standard Deviation 24.31 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Side Effects: Month 12 | 6.3 units on a scale | Standard Deviation 24.63 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Effectiveness: Month 12 | 3.9 units on a scale | Standard Deviation 24.09 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Side Effects: Month 24 | 10.9 units on a scale | Standard Deviation 12.88 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Convenience: Month 6 | 15.4 units on a scale | Standard Deviation 27.25 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Global Satisfaction: Month 12 | 11.1 units on a scale | Standard Deviation 25.95 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Convenience: Month 12 | 7.7 units on a scale | Standard Deviation 29.9 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Effectiveness: Month 24 | 2.8 units on a scale | Standard Deviation 21.52 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Convenience: Month 24 | 1.4 units on a scale | Standard Deviation 53.74 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Global Satisfaction: Month 6 | 18.5 units on a scale | Standard Deviation 30.42 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Effectiveness: Month 6 | 10.5 units on a scale | Standard Deviation 29.13 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Convenience: Month 24 | 44.4 units on a scale | — |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Global Satisfaction: Month 6 | 22.2 units on a scale | Standard Deviation 15.14 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Global Satisfaction: Month 12 | 19.0 units on a scale | Standard Deviation 21.82 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Global Satisfaction: Month 24 | -28.6 units on a scale | — |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Effectiveness: Month 6 | 22.2 units on a scale | Standard Deviation 21.08 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Effectiveness: Month 12 | 24.1 units on a scale | Standard Deviation 30.6 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Effectiveness: Month 24 | 16.7 units on a scale | — |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Side Effects: Month 6 | 7.1 units on a scale | Standard Deviation 16.31 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Side Effects: Month 12 | 2.1 units on a scale | Standard Deviation 40.67 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Convenience: Month 6 | 24.6 units on a scale | Standard Deviation 14.29 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Convenience: Month 12 | 18.5 units on a scale | Standard Deviation 28.51 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Baseline | 44.2 units on a scale | Standard Deviation 11.17 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Month 6 | 0.4 units on a scale | Standard Deviation 5.43 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Month 12 | 0.2 units on a scale | Standard Deviation 6.44 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Month 24 | 1.0 units on a scale | Standard Deviation 6.06 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Baseline | 48.2 units on a scale | Standard Deviation 9.35 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Month 6 | 2.3 units on a scale | Standard Deviation 8.63 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Month 12 | 0.8 units on a scale | Standard Deviation 7.98 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Month 24 | -0.6 units on a scale | Standard Deviation 8.77 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Month 24 | 2.8 units on a scale | Standard Deviation 10.42 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Baseline | 38.1 units on a scale | Standard Deviation 10.76 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Baseline | 46.4 units on a scale | Standard Deviation 12.01 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Month 6 | 2.2 units on a scale | Standard Deviation 6.75 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Month 12 | -2.9 units on a scale | Standard Deviation 4.7 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Month 12 | -1.9 units on a scale | Standard Deviation 5.54 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | MCS: Month 6 | -1.6 units on a scale | Standard Deviation 6.45 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | PCS: Month 24 | -2.0 units on a scale | Standard Deviation 6.94 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Baseline | 1.8 units on a scale | Standard Deviation 2.08 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Month 6 | 0.5 units on a scale | Standard Deviation 1.54 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Month 12 | 0.2 units on a scale | Standard Deviation 1.77 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Month 24 | 0.8 units on a scale | Standard Deviation 1.48 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Month 24 | 0.3 units on a scale | Standard Deviation 2.52 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Baseline | 3.5 units on a scale | Standard Deviation 3.55 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Month 12 | 1.0 units on a scale | Standard Deviation 2.16 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 | Month 6 | 1.0 units on a scale | Standard Deviation 1.7 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Baseline | 9.0 units on a scale | Standard Deviation 5.14 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Month 6 | 0.0 units on a scale | Standard Deviation 2.43 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Month 12 | -0.3 units on a scale | Standard Deviation 2.87 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Month 24 | 0.9 units on a scale | Standard Deviation 3.29 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Month 24 | 2.0 units on a scale | Standard Deviation 1.41 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Baseline | 10.5 units on a scale | Standard Deviation 5.22 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Month 12 | 1.5 units on a scale | Standard Deviation 1 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 | Month 6 | -0.8 units on a scale | Standard Deviation 3.52 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Baseline | 2.1 units on a scale | Standard Deviation 2.7 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Month 6 | -0.1 units on a scale | Standard Deviation 1.01 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Month 12 | 0.0 units on a scale | Standard Deviation 0.87 |
| Cladribine Tablets: Switch From Oral | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Month 24 | -0.2 units on a scale | Standard Deviation 1.04 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Month 24 | 0.0 units on a scale | Standard Deviation 1.1 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Baseline | 3.4 units on a scale | Standard Deviation 2.47 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Month 12 | -0.1 units on a scale | Standard Deviation 0.81 |
| Cladribine Tablets: Switch From Infusion | Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 | Month 6 | -0.4 units on a scale | Standard Deviation 0.67 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 6 | 3.5 percentage of activity impairment | Standard Deviation 27.58 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 12 | -12.2 percentage of activity impairment | Standard Deviation 23.4 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 24 | 0.0 percentage of activity impairment | Standard Deviation 18.52 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 6 | -8.9 percentage of activity impairment | Standard Deviation 18.33 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 12 | 10.0 percentage of activity impairment | Standard Deviation 14.14 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 24 | -10.0 percentage of activity impairment | Standard Deviation 14.14 |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 6 | -10.0 percentage of impairment while working | Standard Deviation 16.58 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 24 | -1.7 percentage of impairment while working | Standard Deviation 18.35 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 12 | -10.0 percentage of impairment while working | Standard Deviation 34.32 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 6 | -10.0 percentage of impairment while working | — |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 12 | 0.0 percentage of impairment while working | — |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 6 | -10.0 percentage of overall work impairment | Standard Deviation 16.58 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 12 | -9.8 percentage of overall work impairment | Standard Deviation 34.4 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 24 | -1.7 percentage of overall work impairment | Standard Deviation 18.35 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 6 | -10.0 percentage of overall work impairment | — |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 12 | 0.0 percentage of overall work impairment | — |
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.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 6 | 0.0 percentage of work time missed | Standard Deviation 39.22 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 12 | -7.7 percentage of work time missed | Standard Deviation 25.46 |
| Cladribine Tablets: Switch From Oral | 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 | Change at Month 24 | 0.00 percentage of work time missed | Standard Deviation 0 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 6 | -8.7 percentage of work time missed | Standard Deviation 17.76 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 12 | 30.8 percentage of work time missed | Standard Deviation 60.08 |
| Cladribine Tablets: Switch From Infusion | 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 | Change at Month 24 | -100.0 percentage of work time missed | — |
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.
Time frame: Baseline (Month 0) up to 24 Months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cladribine Tablets: Switch From Oral | Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | 12.8 months |
| Cladribine Tablets: Switch From Infusion | Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | 13.1 months |
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.
Time frame: Baseline (Month 0) up to 24 Months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Doses Received by Participants as Per United States Prescribing Information | 24.0 number of doses received |
| Cladribine Tablets: Switch From Infusion | Number of Doses Received by Participants as Per United States Prescribing Information | 25.0 number of doses received |
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.
Time frame: Over the 12-month and 24-month period
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Participants Who Experienced Relapse | Over the 12-month period | 4 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants Who Experienced Relapse | Over the 24-month period | 6 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants Who Experienced Relapse | Over the 12-month period | 4 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants Who Experienced Relapse | Over the 24-month period | 4 Participants |
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).
Time frame: Month 1, 2, 13 and 14
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 1 | 71 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 2 | 72 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 13 | 32 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 14 | 20 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 14 | 11 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 1 | 50 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 13 | 22 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 2 | 53 Participants |
Secondary
Number of Participants With At Least One Concomitant Medication
Number of participants with at least one concomitant medication were reported.
Time frame: Baseline (Month 0) up to 24 Months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Participants With At Least One Concomitant Medication | 98 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With At Least One Concomitant Medication | 73 Participants |
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.
Time frame: Baseline (Month 0) up to 24 Months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Adverse Event | 9 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Lost to follow-up | 12 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Protocol deviation | 4 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Progressive disease | 1 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Withdrew consent from study | 9 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Other/ Not Mentioned | 8 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Withdrew consent from study | 5 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Adverse Event | 1 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Progressive disease | 3 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Lost to follow-up | 6 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Other/ Not Mentioned | 2 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Reason for Discontinuation of Cladribine Tablets | Protocol deviation | 2 Participants |
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.
Time frame: Baseline (Month 0) up to 24 months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | SAEs | 10 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | AESIs | 15 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | ADR | 35 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | Special Situation | 0 Participants |
| Cladribine Tablets: Switch From Oral | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | TEAEs | 65 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | Special Situation | 4 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | TEAEs | 51 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | SAEs | 14 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | ADR | 19 Participants |
| Cladribine Tablets: Switch From Infusion | Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) | AESIs | 7 Participants |
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.
Time frame: At Baseline (Month 0)
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | 3.0 number of DMDs received | Standard Deviation 1.66 |
| Cladribine Tablets: Switch From Infusion | Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | 3.4 number of DMDs received | Standard Deviation 1.82 |
Secondary
Percentage of Participants Who Discontinued Cladribine Tablets
Percentage of participants who discontinued cladribine tablets were reported.
Time frame: Baseline (Month 0) up to 24 Months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cladribine Tablets: Switch From Oral | Percentage of Participants Who Discontinued Cladribine Tablets | 41.7 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants Who Discontinued Cladribine Tablets | 22.4 percentage of participants |
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.
Time frame: Over the 12-month period, 13th to 24th month and over the 24 month period.
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Relapse Associated With Glucocorticoid Use | Over the 12-month period | 1.0 percentage of participants |
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Relapse Associated With Glucocorticoid Use | 13th to 24th month period | 1.0 percentage of participants |
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Relapse Associated With Glucocorticoid Use | Over the 24-month period | 1.9 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Relapse Associated With Glucocorticoid Use | Over the 12-month period | 3.5 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Relapse Associated With Glucocorticoid Use | 13th to 24th month period | 0.0 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Relapse Associated With Glucocorticoid Use | Over the 24-month period | 2.4 percentage of participants |
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.
Time frame: Over the 12-month period, 13th to 24th month and over the 24 month period.
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Relapse Associated With Hospitalization | Over the 12-month period | 1.0 percentage of participants |
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Relapse Associated With Hospitalization | 13th to 24th month period | 0 percentage of participants |
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Relapse Associated With Hospitalization | Over the 24-month period | 1.0 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Relapse Associated With Hospitalization | Over the 24-month period | 0.0 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Relapse Associated With Hospitalization | Over the 12-month period | 0.0 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Relapse Associated With Hospitalization | 13th to 24th month period | 0.0 percentage of participants |
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.
Time frame: Baseline (Month 0) up to 24 Months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cladribine Tablets: Switch From Oral | Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets | 4.7 percentage of participants |
| Cladribine Tablets: Switch From Infusion | Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets | 5.2 percentage of participants |
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.
Time frame: Baseline (Month 0) up to 24 Months
Population: The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cladribine Tablets: Switch From Oral | Total Planned Doses Received by Participants as Per United States Prescribing Information | 3.4 mg/kg |
| Cladribine Tablets: Switch From Infusion | Total Planned Doses Received by Participants as Per United States Prescribing Information | 3.5 mg/kg |