An observational study in Multiple Sclerosis, sponsored by EMD Serono Research & Development Institute, Inc.. Completed at 66 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by EMD Serono Research & Development Institute, Inc. · Observational
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 660 are open to participants now.
This study's enrollment of 291 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →EMD Serono Research & Development Institute, Inc. is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 38 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).
Exclusion Criteria:
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.
Drug: Cladribine Tablets
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.
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
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
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
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
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
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
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
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
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
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
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
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
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.
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
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.
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
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)
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
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
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
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
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
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
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
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)
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
| Milestone | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Started | 163 | 120 |
| Participants who received at least 1 dose of cladribine tablets | 103 | 85 |
| Switch from ocrelizumab | 0 | 53 |
| Completed | 116 | 92 |
| Not completed | 47 | 28 |
| Withdrew: Participant withdrawn by principal investigator | 1 | 0 |
| Withdrew: Participant transferred care | 1 | 0 |
| Withdrew: Site research department closing | 1 | 0 |
| Withdrew: Site closed prematurely due to unexpected circumstances | 0 | 1 |
| Withdrew: Participant discontinuation due to sponsor decision to close study | 0 | 2 |
| Withdrew: Participant changed primary neurology provider | 1 | 0 |
| Withdrew: Participant could not be entered as a follow-up | 0 | 1 |
| Withdrew: Participant non-compliant, therefore, has been discontinued | 1 | 0 |
| Withdrew: Participant delayed year 2 due to subject fear of covid-19 | 1 | 0 |
| Withdrew: Missed visit | 0 | 1 |
| Withdrew: Investigator decision | 4 | 0 |
| Withdrew: Discontinuation due to safety extension removal by sponsor | 0 | 1 |
| Withdrew: Withdrawal by subject | 10 | 8 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Progressive disease | 0 | 3 |
| Withdrew: Protocol non-compliance | 6 | 3 |
| Withdrew: Lost to follow-up | 16 | 8 |
| Withdrew: Adverse event | 3 | 0 |
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.
| units on a scale | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Global Satisfaction: Month 6 | 18.5 ± 30.42 | 22.2 ± 15.14 |
| Global Satisfaction: Month 12 | 11.1 ± 25.95 | 19.0 ± 21.82 |
| Global Satisfaction: Month 24 | 16.1 ± 24.31 | -28.6 ± NA |
| Effectiveness: Month 6 | 10.5 ± 29.13 | 22.2 ± 21.08 |
| Effectiveness: Month 12 | 3.9 ± 24.09 | 24.1 ± 30.60 |
| Effectiveness: Month 24 | 2.8 ± 21.52 | 16.7 ± NA |
| Side Effects: Month 6 | 11.4 ± 40.28 | 7.1 ± 16.31 |
| Side Effects: Month 12 | 6.3 ± 24.63 | 2.1 ± 40.67 |
| Side Effects: Month 24 | 10.9 ± 12.88 | — |
| Convenience: Month 6 | 15.4 ± 27.25 | 24.6 ± 14.29 |
| Convenience: Month 12 | 7.7 ± 29.90 | 18.5 ± 28.51 |
| Convenience: Month 24 | 1.4 ± 53.74 | 44.4 ± NA |
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.
| units on a scale | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| PCS: Baseline | 44.2 ± 11.17 | 38.1 ± 10.76 |
| PCS: Month 6 | 0.4 ± 5.43 | 2.2 ± 6.75 |
| PCS: Month 12 | 0.2 ± 6.44 | -1.9 ± 5.54 |
| PCS: Month 24 | 1.0 ± 6.06 | -2.0 ± 6.94 |
| MCS: Baseline | 48.2 ± 9.35 | 46.4 ± 12.01 |
| MCS: Month 6 | 2.3 ± 8.63 | -1.6 ± 6.45 |
| MCS: Month 12 | 0.8 ± 7.98 | -2.9 ± 4.70 |
| MCS: Month 24 | -0.6 ± 8.77 | 2.8 ± 10.42 |
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.
| units on a scale | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Baseline | 9.0 ± 5.14 | 10.5 ± 5.22 |
| Month 6 | 0.0 ± 2.43 | -0.8 ± 3.52 |
| Month 12 | -0.3 ± 2.87 | 1.5 ± 1.00 |
| Month 24 | 0.9 ± 3.29 | 2.0 ± 1.41 |
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.
| units on a scale | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Baseline | 1.8 ± 2.08 | 3.5 ± 3.55 |
| Month 6 | 0.5 ± 1.54 | 1.0 ± 1.70 |
| Month 12 | 0.2 ± 1.77 | 1.0 ± 2.16 |
| Month 24 | 0.8 ± 1.48 | 0.3 ± 2.52 |
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.
| percentage of work time missed | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Change at Month 6 | 0.0 ± 39.22 | -8.7 ± 17.76 |
| Change at Month 12 | -7.7 ± 25.46 | 30.8 ± 60.08 |
| Change at Month 24 | 0.00 ± 0.00 | -100.0 ± NA |
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.
| percentage of impairment while working | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Change at Month 6 | -10.0 ± 16.58 | -10.0 ± NA |
| Change at Month 12 | -10.0 ± 34.32 | 0.0 ± NA |
| Change at Month 24 | -1.7 ± 18.35 | — |
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.
| percentage of overall work impairment | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Change at Month 6 | -10.0 ± 16.58 | -10.0 ± NA |
| Change at Month 12 | -9.8 ± 34.40 | 0.0 ± NA |
| Change at Month 24 | -1.7 ± 18.35 | — |
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.
| percentage of activity impairment | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Change at Month 6 | 3.5 ± 27.58 | -8.9 ± 18.33 |
| Change at Month 12 | -12.2 ± 23.40 | 10.0 ± 14.14 |
| Change at Month 24 | 0.0 ± 18.52 | -10.0 ± 14.14 |
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.
| units on a scale | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Baseline | 2.1 ± 2.7 | 3.4 ± 2.47 |
| Month 6 | -0.1 ± 1.01 | -0.4 ± 0.67 |
| Month 12 | 0.0 ± 0.87 | -0.1 ± 0.81 |
| Month 24 | -0.2 ± 1.04 | 0.0 ± 1.10 |
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).
| Participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Month 1 | 71 | 50 |
| Month 2 | 72 | 53 |
| Month 13 | 32 | 22 |
| Month 14 | 20 | 11 |
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.
| Participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Over the 12-month period | 4 | 4 |
| Over the 24-month period | 6 | 4 |
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.
| percentage of participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Over the 12-month period | 1.0 | 0.0 |
| 13th to 24th month period | 0 | 0.0 |
| Over the 24-month period | 1.0 | 0.0 |
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.
| relapses per year | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Month 12 | 0.01 ± 0.114 | 0.00 ± 0.00 |
| Month 24 | 0.01 ± 0.057 | 0.00 ± 0.00 |
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.
| percentage of participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Over the 12-month period | 1.0 | 3.5 |
| 13th to 24th month period | 1.0 | 0.0 |
| Over the 24-month period | 1.9 | 2.4 |
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.
| relapses per year | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Month 12 | 0.01 ± 0.114 | 0.04 ± 0.201 |
| Month 24 | 0.02 ± 0.093 | 0.03 ± 0.142 |
Number of previous DMD received by participants with MS were reported.
| number of DMDs received | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | 3.0 ± 1.66 | 3.4 ± 1.82 |
Percentage of participants who discontinued cladribine tablets were reported.
| percentage of participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Percentage of Participants Who Discontinued Cladribine Tablets | 41.7 | 22.4 |
Number of participants who discontinued cladribine tablets in each category of reason for discontinuation were reported.
| Participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Adverse Event | 9 | 1 |
| Lost to follow-up | 12 | 6 |
| Protocol deviation | 4 | 2 |
| Progressive disease | 1 | 3 |
| Withdrew consent from study | 9 | 5 |
| Other/ Not Mentioned | 8 | 2 |
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.
| months | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | 12.8 (0.0 to 17.4) | 13.1 (0.1 to 22.9) |
Number of doses received by participants as per United States prescribing information were reported.
| number of doses received | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Number of Doses Received by Participants as Per United States Prescribing Information | 24.0 (2.0 to 40.0) | 25.0 (5.0 to 40.0) |
Total planned doses received by participants as per United States Prescribing Information was reported.
| mg/kg | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Total Planned Doses Received by Participants as Per United States Prescribing Information | 3.4 (0.9 to 4.0) | 3.5 (0.9 to 3.9) |
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.
| percentage of participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets | 4.7 | 5.2 |
Number of participants with at least one concomitant medication were reported.
| Participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Number of Participants With At Least One Concomitant Medication | 98 | 73 |
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.
| relapses per year | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Annualized Relapse Rate (ARR) | 0.17 ± 0.313 | 0.14 ± 0.268 |
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.
| Participants | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| TEAEs | 65 | 51 |
| SAEs | 10 | 14 |
| ADR | 35 | 19 |
| AESIs | 15 | 7 |
| Special Situation | 0 | 4 |
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.
| relapses per year | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| Annualized Relapse Rate (ARR) | 0.04 ± 0.145 | 0.03 ± 0.153 |
Collected over Baseline (Month 0) up to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cladribine Tablets: Switch From Oral | 2/103 (1.9%) | 10/103 (9.7%) | 65/103 (63.1%) |
| Cladribine Tablets: Switch From Infusion | 0/85 (0%) | 14/85 (16.5%) | 51/85 (60%) |
| Event | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| PyelonephritisInfections and infestations | 0/103 | 2/85 |
| UreterolithiasisRenal and urinary disorders | 0/103 | 2/85 |
| LymphopeniaBlood and lymphatic system disorders | 0/103 | 1/85 |
| PyrexiaGeneral disorders | 0/103 | 1/85 |
| CholecystitisHepatobiliary disorders | 0/103 | 1/85 |
| Clostridium difficile infectionInfections and infestations | 0/103 | 1/85 |
| COVID-19Infections and infestations | 0/103 | 1/85 |
| SepsisInfections and infestations | 0/103 | 1/85 |
| Tubo-ovarian abscessInfections and infestations | 0/103 | 1/85 |
| UreteritisInfections and infestations | 0/103 | 1/85 |
| Event | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion |
|---|---|---|
| LymphopeniaBlood and lymphatic system disorders | 20/103 | 4/85 |
| FatigueGeneral disorders | 9/103 | 11/85 |
| COVID-19Infections and infestations | 8/103 | 9/85 |
| Urinary tract infectionInfections and infestations | 3/103 | 7/85 |
| NauseaGastrointestinal disorders | 6/103 | 2/85 |
| Back painMusculoskeletal and connective tissue disorders | 6/103 | 4/85 |
| DiarrhoeaGastrointestinal disorders | 5/103 | 1/85 |
| HeadacheNervous system disorders | 5/103 | 3/85 |
| Upper respiratory tract infectionInfections and infestations | 4/103 | 4/85 |
| FallInjury, poisoning and procedural complications | 2/103 | 4/85 |
FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Age, Continuous(years) | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion | Total |
|---|---|---|---|
| Mean | 50 ± 10.8 | 48 ± 12.5 | 49 ± 11.6 |
| Sex: Female, Male(Participants) | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion | Total |
|---|---|---|---|
| Female | 84 | 58 | 142 |
| Male | 19 | 27 | 46 |
| Ethnicity (NIH/OMB)(Participants) | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 93 | 74 | 167 |
| Unknown or Not Reported | 5 | 8 | 13 |
| Race (NIH/OMB)(Participants) | Cladribine Tablets: Switch From Oral | Cladribine Tablets: Switch From Infusion | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 13 | 6 | 19 |
| White | 85 | 68 | 153 |
| More than one race | 0 | 4 | 4 |
| Unknown or Not Reported | 4 | 5 | 9 |
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