An observational study in Multiple Sclerosis, sponsored by EMD Serono Research & Development Institute, Inc.. Completed at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by EMD Serono Research & Development Institute, Inc. · Observational
To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (RMS) including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS),who transition to cladribine tablets after suboptimal response to any injectable 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; 661 are open to participants now.
This study's enrollment of 100 is close to 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 Multiple Sclerosis and experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to prior treatment with an injectable DMD.
Exclusion Criteria:
Drug: Cladribine
Participants received 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)
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).
Time frame: Baseline (Month 0) 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) Score at Month 6, 12 and 24
SF-36 was a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100 for each component summary (i.e., PCS and MCS), where higher scores are associated with less disability and better quality of life.
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
MFIS-5 is a modified form of the Fatigue Impact Scale that consists of 5 questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with 5 response levels ranging from 0 to 4, where 0 = (Never), 1 = (Rarely), 2 = (Sometimes), 3 = (Often), 4 = (Almost always). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
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 items BDI-FS is a self-report inventory for measuring the severity of depression on a 7-item scale. The BDI-Fast Screen is scored by summing all of the highest ratings for each of the 7 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 21. Higher scores indicate greater symptom severity.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Change From Baseline in Percent 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-items 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 percent work time missed (absenteeism) was reported.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Change From Baseline in Percent 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-items 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 Percent 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-items 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 Percent 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-items 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 percent 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
PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale ranges from 0 to 8, where 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 represented higher level of disability.
Time frame: Baseline (Month 0), Month 6, 12 and 24
Number of Participants With Adherence to Cladribine 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: Baseline (Month 0) and Months 1, 2, 13 and 14
Percentage of Participants Who Experienced Relapse 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). Percentage of participants who experienced relapse at Months 12 and 24 were reported.
Time frame: Months 12 and 24
Annualized Relapse Rate (ARR) at Month 12
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).
Time frame: At Month 12
Percentage of Participants Who Experienced Relapse Associated With Hospitalization
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). Percentage of participants who experienced relapse associated with hospitalization at Months 12 and 24 were reported.
Time frame: Months 12 and 24
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 associated with hospitalization at Months 12 and 24 were reported.
Time frame: Months 12 and 24
Percentage of Participants Who Experienced Relapse Associated With Glucocorticoid Use
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).Percentage of participants who experienced relapse associated with glucocorticoid use at Months 12 and 24 were reported.
Time frame: Months 12 and 24
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 associated with glucocorticoid use at Months 12 and 24 were reported.
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
Number of Participants Who Received At Least One Concomitant Medication
Number of participants who received at least one concomitant medication were reported.
Time frame: Baseline up to Month 24
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
Elapsed Time to Discontinuation After First Dose of Cladribine Tablets
Elapsed time to discontinuation after first dose of cladribine tablets was reported.
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
Percentage of Participants With Treatment Compliance as Per United States Prescribing Information
Treatment compliance was defined as total actual number of cladribine tablets / total planned number of cladribine tablets.
Time frame: Baseline (Month 0) up to 24 Months
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.
Time frame: Baseline (Month 0) up to 24 months
| Milestone | Cladribine |
|---|---|
| Started | 100 |
| Treated | 62 |
| Completed | 34 |
| Not completed | 66 |
| Withdrew: Other | 6 |
| Withdrew: Sponsor decision | 5 |
| Withdrew: Protocol violation | 5 |
| Withdrew: Withdrawal by subject | 6 |
| Withdrew: Lost to follow-up | 6 |
| Withdrew: Enrolled but not treated | 38 |
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).
| relapses per year | Cladribine |
|---|---|
| Annualized Relapse Rate (ARR) | 0.02 (0.000 to 0.059) |
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 |
|---|---|
| Global Satisfaction: change at Month 6 | 32.9 ± 29.01 |
| Global Satisfaction: change at Month 12 | 26.2 ± 21.43 |
| Global Satisfaction: change at Month 24 | 7.1 ± NA |
| Effectiveness: change at Month 6 | 24.4 ± 23.45 |
| Effectiveness: change at Month 12 | 7.4 ± 35.13 |
| Effectiveness: change at Month 24 | -5.6 ± NA |
| Side Effects: change at Month 6 | -8.8 ± 41.37 |
| Side Effects: change at Month 12 | -18.1 ± 24.69 |
| Side Effects: change at Month 24 | 0.0 ± NA |
| Convenience: change at Month 6 | 35.0 ± 21.44 |
| Convenience: change at Month 12 | 24.7 ± 19.66 |
| Convenience: change at Month 24 | 33.3 ± NA |
SF-36 was a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100 for each component summary (i.e., PCS and MCS), where higher scores are associated with less disability and better quality of life.
| units on a scale | Cladribine |
|---|---|
| PCS: Change at Month 6 | 4.1 ± 6.90 |
| PCS: Change at Month 12 | -0.4 ± 5.68 |
| PCS: Change at Month 24 | 1.9 ± NA |
| MCS: Change at Month 6 | 0.9 ± 7.66 |
| MCS: Change at Month 12 | 0.3 ± 8.05 |
| MCS: Change at Month 24 | -2.5 ± NA |
MFIS-5 is a modified form of the Fatigue Impact Scale that consists of 5 questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with 5 response levels ranging from 0 to 4, where 0 = (Never), 1 = (Rarely), 2 = (Sometimes), 3 = (Often), 4 = (Almost always). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
| units on a scale | Cladribine |
|---|---|
| Change at Month 6 | -2.1 ± 3.42 |
| Change at Month 12 | 0.4 ± 4.73 |
| Change at Month 24 | 0.0 ± NA |
The 7 items BDI-FS is a self-report inventory for measuring the severity of depression on a 7-item scale. The BDI-Fast Screen is scored by summing all of the highest ratings for each of the 7 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 21. Higher scores indicate greater symptom severity.
| units on a scale | Cladribine |
|---|---|
| Change at Month 6 | -1.3 ± 3.09 |
| Change at Month 12 | -0.1 ± 3.04 |
| Change at Month 24 | -1.0 ± 2.83 |
The WPAI-MS questionnaire is a 6-items 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 percent work time missed (absenteeism) was reported.
| percentage of work time missed | Cladribine |
|---|---|
| Change at Month 6 | 3.1 ± 16.37 |
| Change at Month 12 | -6.3 ± 28.64 |
| Change at Month 24 | 0.0 ± 0.00 |
The WPAI-MS questionnaire is a 6-items 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 |
|---|---|
| Change at Month 6 | -11.4 ± 6.90 |
| Change at Month 12 | -5.0 ± 22.24 |
| Change at Month 24 | 0.0 ± NA |
The WPAI-MS questionnaire is a 6-items 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 |
|---|---|
| Change at Month 6 | -5.1 ± 18.73 |
| Change at Month 12 | -6.1 ± 19.99 |
| Change at Month 24 | 0.0 ± NA |
The WPAI-MS questionnaire is a 6-items 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 percent activity impairment was reported.
| percentage of activity impairment | Cladribine |
|---|---|
| Change at Month 6 | -10.0 ± 10.00 |
| Change at Month 12 | -7.7 ± 21.27 |
| Change at Month 24 | -5.0 ± 7.07 |
PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale ranges from 0 to 8, where 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 represented higher level of disability.
| units on a scale | Cladribine |
|---|---|
| Change at Month 6 | -0.2 ± 0.69 |
| Change at Month 12 | -0.3 ± 0.72 |
| Change at Month 24 | -0.1 ± 1.17 |
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 |
|---|---|
| At Baseline | 28 |
| Month 1 | 38 |
| Month 2 | 38 |
| Month 13 | 21 |
| Month 14 | 18 |
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). Percentage of participants who experienced relapse at Months 12 and 24 were reported.
| percentage of participants | Cladribine |
|---|---|
| Month 12 | 1.6 |
| Month 24 | 1.6 |
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).
| relapses per year | Cladribine |
|---|---|
| Annualized Relapse Rate (ARR) at Month 12 | 0.01955 (0.0 to 0.1) |
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). Percentage of participants who experienced relapse associated with hospitalization at Months 12 and 24 were reported.
| percentage of participants | Cladribine |
|---|---|
| Month 12 | 0.0 |
| Month 24 | 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 associated with hospitalization at Months 12 and 24 were reported.
| relapses per year | Cladribine |
|---|---|
| Month 12 | 0.0 (0.0 to NA) |
| Month 24 | 0.0 (0.0 to NA) |
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).Percentage of participants who experienced relapse associated with glucocorticoid use at Months 12 and 24 were reported.
| percentage of participants | Cladribine |
|---|---|
| Month 12 | 0.0 |
| Month 24 | 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 associated with glucocorticoid use at Months 12 and 24 were reported.
| relapses per year | Cladribine |
|---|---|
| Month 12 | 0.0 (0.0 to NA) |
| Month 24 | 0.0 (0.0 to NA) |
Number of previous DMD received by participants with MS were reported.
| number of DMDs received | Cladribine |
|---|---|
| Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline | 1.9 ± 1.14 |
Number of participants who received at least one concomitant medication were reported.
| Participants | Cladribine |
|---|---|
| Number of Participants Who Received At Least One Concomitant Medication | 60 |
Percentage of participants who discontinued cladribine tablets were reported.
| percentage of participants | Cladribine |
|---|---|
| Percentage of Participants Who Discontinued Cladribine Tablets | 32.3 |
Elapsed time to discontinuation after first dose of cladribine tablets was reported.
| months | Cladribine |
|---|---|
| Elapsed Time to Discontinuation After First Dose of Cladribine Tablets | 13.2 (12.2 to 14.1) |
Number of doses received by participants as per United States prescribing information were reported.
| number of doses received | Cladribine |
|---|---|
| Number of Doses Received by Participants as Per United States Prescribing Information | 28.00 (18.00 to 34.00) |
Treatment compliance was defined as total actual number of cladribine tablets / total planned number of cladribine tablets.
| percentage of participants | Cladribine |
|---|---|
| Percentage of Participants With Treatment Compliance as Per United States Prescribing Information | 82.3 |
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.
| Participants | Cladribine |
|---|---|
| SAE | 3 |
| ADR | 18 |
| AESI | 9 |
Collected over Baseline up to 24 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cladribine | 0/62 (0%) | 3/62 (4.8%) | 34/62 (54.8%) |
| Event | Cladribine |
|---|---|
| GastritisGastrointestinal disorders | 1/62 |
| Anal squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/62 |
| Low absolute lymphocyte countInvestigations | 1/62 |
| Suspected infection of the kidneyInfections and infestations | 1/62 |
| Event | Cladribine |
|---|---|
| LymphopeniaBlood and lymphatic system disorders | 9/62 |
| COVID-19Infections and infestations | 5/62 |
| Herpes zosterInfections and infestations | 4/62 |
| Urinary tract infectionInfections and infestations | 3/62 |
| Abdominal discomfortGastrointestinal disorders | 2/62 |
| NauseaGastrointestinal disorders | 2/62 |
| PyrexiaGeneral disorders | 2/62 |
| HypersensitivityImmune system disorders | 2/62 |
| BronchitisInfections and infestations | 2/62 |
| Upper respiratory tract infectionInfections and infestations | 2/62 |
The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets.
| Age, Continuous(years) | Cladribine |
|---|---|
| Mean | 49 ± 12.4 |
| Sex: Female, Male(Participants) | Cladribine |
|---|---|
| Female | 49 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Cladribine |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 51 |
| Unknown or Not Reported | 9 |
| Race (NIH/OMB)(Participants) | Cladribine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 52 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
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