Multiple Sclerosis (MS)
Conditions
Keywords
Multiple Sclerosis, Cladribine, High Disease Activity
Brief summary
The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).
Interventions
OTHERData Collection
No study treatment was administered as part of this study
Sponsors
Merck KGaA, Darmstadt, Germany
EMD Serono Research & Development Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants with relapsing remitting multiple sclerosis (RRMS) randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (\>=) 1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo * Participants with their first clinical demyelinating event randomised in ORACLE MS clinical trial who have received \>= 1 course of IMP Cladribine Tablets or placebo * Participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol
Exclusion criteria
* Participants who has any uncontrolled disease state other than MS, that in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation * For study participants at selected sites where MRI assessment will be conducted following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher | 3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening) | EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with Multiple Sclerosis (MS) disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day. Score of 8.0 is defined as Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Demographic Characteristic: Age, Disease Duration | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | Clinical and demographic characteristics including age and disease duration is reported in the form of long term responders and non-responder. Here long term responder is defined as study participants not requiring disease modifying drug (DMD) 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
| Number of Participants in Each Category of Clinical and Demographic Characteristics | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | Clinical and demographic characteristics included gender, race, disease classification (relapsing remitting multiple sclerosis \[RRMS\], Secondary Progressive Multiple Sclerosis \[SPMS\], unknown & no MS disease), Prior use of DMDs & high-disease activity (HAD) status, education level and employment status. Number of participants in each category of clinical and demographic characteristics were reported in form of long term responders & non-responder. Here long term responder is defined as participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD \< 4 years following their last dose of IMP in parent study. |
| Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDSS scores range from 0.0 (normal) to 10.0 (dead). Clinical characteristics of EDSS score in form of long-term responders & non-responder was reported for at parent study baseline (based on retrospective data collection \[based on chart review\] at study visit 1) & study visit 1. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD \< 4 years following their last dose of IMP in parent study. |
| Clinical Characteristic: Number of Relapses | At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | Relapse was defined as participant-reported symptoms & objectively observed signs typical of an acute inflammatory demyelinating event in CNS, developing acutely or sub-acutely with duration of at least 24 hours, in absence of fever or infection. Clinical characteristics of number of relapses during last year before enrollment of parent study (it is reported based on retrospective data collection \[based on chart review\] at study visit 1) in the form of long-term responders & non-responder was reported. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
| Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher | At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening) | EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as intermittent or unilateral constant assistance (cane, crutch and brace) required to walk about 100 meters with or without resting. |
| Number of Total T2-weighted (T2-W) Lesions | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | Total number of T2-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
| T1-weighted (T1-W) Lesion Volume | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | T1-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
| T2-weighted (T2-W) Lesion Volume | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | T2-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
| Total Brain Volume | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | Brain volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
| Number of Total T1-weighted (T1-W) Lesions | At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985) | Total number of T1-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study. |
Countries
Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Czechia, Estonia, Finland, France, Georgia, Germany, Italy, Lebanon, Lithuania, Norway, Poland, Portugal, Romania, Russia, Serbia, South Korea, Spain, Sweden, Switzerland, Tunisia, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 662 subjects were enrolled in this trial at different sites in United States and Europe.
Participants by arm
| Arm | Count |
|---|---|
| Cohort A Participants previously enrolled in parent studies CLARITY (NCT00213135), CLARITY-EXT (NCT00641537), ORACLE (NCT00725985) and had received Cladribine tablet and Placebo were invited up to 2 visit for follow-up/data collection. | 662 |
| Total | 662 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Missing | 1 |
| Overall Study | Other | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Cohort A |
|---|---|
| Age, Continuous | 49.3 Years STANDARD_DEVIATION 10.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 8 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 645 Participants |
| Sex: Female, Male Female | 444 Participants |
| Sex: Female, Male Male | 218 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 662 |
| other Total, other adverse events | 8 / 662 |
| serious Total, serious adverse events | 1 / 662 |
Outcome results
Primary
Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with Multiple Sclerosis (MS) disability/neurologic function level where 0=normal and 10=death due to MS. Score of 7.0 is defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day. Score of 8.0 is defined as Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms.
Time frame: 3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
Population: FAS included all participants participating in CLASSIC study \[randomized in CLARITY and have received ≥ 1 course of investigational medicinal product (IMP) (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP\]. Number of participants analyzed signifies number of participants who were evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Percentage of Participants Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher | 8.2 percentage of participant |
Secondary
Clinical and Demographic Characteristic: Age, Disease Duration
Clinical and demographic characteristics including age and disease duration is reported in the form of long term responders and non-responder. Here long term responder is defined as study participants not requiring disease modifying drug (DMD) 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: FAS included all participants participating in CLASSIC study \[randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP\]. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Clinical and Demographic Characteristic: Age, Disease Duration | Long-term responders: Age at study visit 1 | 50.5 years | Standard Deviation 10.65 |
| Cohort A | Clinical and Demographic Characteristic: Age, Disease Duration | Non-responders: Age at study visit 1 | 47.1 years | Standard Deviation 9.47 |
| Cohort A | Clinical and Demographic Characteristic: Age, Disease Duration | Long term responder: Disease duration | 19.82 years | Standard Deviation 9.161 |
| Cohort A | Clinical and Demographic Characteristic: Age, Disease Duration | Non-responder: Disease duration | 16.82 years | Standard Deviation 8.321 |
Secondary
Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDSS scores range from 0.0 (normal) to 10.0 (dead). Clinical characteristics of EDSS score in form of long-term responders & non-responder was reported for at parent study baseline (based on retrospective data collection \[based on chart review\] at study visit 1) & study visit 1. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD \< 4 years following their last dose of IMP in parent study.
Time frame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: FAS included all participants participating in CLASSIC study \[randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP\]. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score | Long-term responders: EDSS score at parent study baseline | 2.44 score on a scale | Standard Deviation 1.292 |
| Cohort A | Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score | Non-responders: EDSS score at parent study baseline | 2.38 score on a scale | Standard Deviation 1.251 |
| Cohort A | Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score | Long term responder: EDSS score at study visit 1 | 3.23 score on a scale | Standard Deviation 2.121 |
| Cohort A | Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score | Non-responder: EDSS score at study visit 1 | 3.32 score on a scale | Standard Deviation 2.102 |
Secondary
Clinical Characteristic: Number of Relapses
Relapse was defined as participant-reported symptoms & objectively observed signs typical of an acute inflammatory demyelinating event in CNS, developing acutely or sub-acutely with duration of at least 24 hours, in absence of fever or infection. Clinical characteristics of number of relapses during last year before enrollment of parent study (it is reported based on retrospective data collection \[based on chart review\] at study visit 1) in the form of long-term responders & non-responder was reported. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: FAS included all participants participating in CLASSIC study \[randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP\]. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Clinical Characteristic: Number of Relapses | Long-term responders: number of relapses during last year before enrollment of parent study | 1.3 Relapses | Standard Deviation 0.64 |
| Cohort A | Clinical Characteristic: Number of Relapses | Non-responders: number of relapses during last year before enrollment of parent study | 1.3 Relapses | Standard Deviation 0.56 |
Secondary
Number of Participants in Each Category of Clinical and Demographic Characteristics
Clinical and demographic characteristics included gender, race, disease classification (relapsing remitting multiple sclerosis \[RRMS\], Secondary Progressive Multiple Sclerosis \[SPMS\], unknown & no MS disease), Prior use of DMDs & high-disease activity (HAD) status, education level and employment status. Number of participants in each category of clinical and demographic characteristics were reported in form of long term responders & non-responder. Here long term responder is defined as participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD \< 4 years following their last dose of IMP in parent study.
Time frame: At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: FAS included all participants participating in CLASSIC study \[randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP\]. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Sex (Female) | 251 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Sex (Female) | 171 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long-term responder: Sex (Male) | 127 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Sex (Male) | 78 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Race (White) | 368 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Race (White) | 244 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Race (Black or African American) | 1 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Race (Black or African American) | 0 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Race (Asian) | 5 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Race (Asian) | 3 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Race (Other) | 4 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Race (Other) | 2 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Type of MS-RRMS | 259 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Type of MS-RRMS | 173 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Type of MS-SPMS | 71 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Type of MS-SPMS | 41 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Type of MS-Unknown | 0 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Type of MS -Unknown | 14 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Type of MS-No MS disease | 48 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Type of MS-No MS disease | 21 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Prior Use of DMDs | 57 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Prior Use of DMDs | 33 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: HDA participants | 83 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: HDA participants | 35 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Education level (Below 8 Years) | 19 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Education level (Below 8 Years) | 16 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Education level (8 to 10 Years) | 73 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non- responder: Education level (8 to 10 Years) | 43 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Education level (10 to 15 Years) | 190 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Education level (10 to 15 Years) | 130 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Education level (Over 15 Years) | 91 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Education level (Over 15 Years) | 56 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Employed for wages) | 160 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Employed for wages) | 122 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Self-Employed) | 38 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Self-Employed) | 17 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Out of Work for more than 1 year) | 12 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Out of Work for more than 1 year) | 13 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Out of Work for less than 1 year) | 4 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Out of Work for less than 1 year) | 2 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (A Homemaker) | 22 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (A Homemaker) | 24 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Retired) | 67 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Retired) | 19 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Unable to work) | 48 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Unable to work) | 26 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Not collected at the site) | 3 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Not collected at the site) | 6 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Long term responder: Employment Status (Unknown/Not reported) | 24 Participants |
| Cohort A | Number of Participants in Each Category of Clinical and Demographic Characteristics | Non-responder: Employment Status (Unknown/Not reported) | 20 Participants |
Secondary
Number of Total T1-weighted (T1-W) Lesions
Total number of T1-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Number of Total T1-weighted (T1-W) Lesions | Long-term responder | 12.7 lesions | Standard Deviation 8.97 |
| Cohort A | Number of Total T1-weighted (T1-W) Lesions | Non-responder | 16.1 lesions | Standard Deviation 10.9 |
Secondary
Number of Total T2-weighted (T2-W) Lesions
Total number of T2-W lesion were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Number of Total T2-weighted (T2-W) Lesions | Long-term responder | 20.2 lesions | Standard Deviation 18.67 |
| Cohort A | Number of Total T2-weighted (T2-W) Lesions | Non-responder | 25.1 lesions | Standard Deviation 18.17 |
Secondary
Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher
EDSS is a scale based on standardized neurological examination which comprised of optic, brain stem, pyramidal, cerebellar, sensory & cerebral functions, as well as walking ability. EDDS is a scale from 0-10 that evaluates a person with MS disability/neurologic function level where 0= normal and 10= death due to MS. Score of 6.0 is defined as intermittent or unilateral constant assistance (cane, crutch and brace) required to walk about 100 meters with or without resting.
Time frame: At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)
Population: FAS included all participants participating in CLASSIC study \[randomized in CLARITY and have received ≥ 1 course of IMP (Cladribine Tablets or placebo) or participants randomized in the ORACLE study and have received ≥ 1 course of IMP\].
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort A | Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher | 13.9 percentage of participant |
Secondary
T1-weighted (T1-W) Lesion Volume
T1-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | T1-weighted (T1-W) Lesion Volume | Long-term responder | 1.655 cubic centimeter (cm^3) | Standard Deviation 1.3953 |
| Cohort A | T1-weighted (T1-W) Lesion Volume | Non-responder | 6.773 cubic centimeter (cm^3) | Standard Deviation 6.4788 |
Secondary
T2-weighted (T2-W) Lesion Volume
T2-W lesion volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | T2-weighted (T2-W) Lesion Volume | Long-term responder | 4.920 cubic centimeter (cm^3) | Standard Deviation 6.7665 |
| Cohort A | T2-weighted (T2-W) Lesion Volume | Non-responder | 14.664 cubic centimeter (cm^3) | Standard Deviation 13.8109 |
Secondary
Total Brain Volume
Brain volume were measured by Using magnetic resonance imaging (MRI) Scans. Here long term responder is defined as study participants not requiring DMD 4 years or later following their last dose of IMP in parent study. Non-responder is defined as study participants requiring DMD less than 4 years following their last dose of IMP in parent study.
Time frame: At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)
Population: The MRI analysis population includes all FAS participants who signed the MRI sub- study informed consent. Here, Overall Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure and Number analyzed refers to number of participants evaluable for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort A | Total Brain Volume | Long-term responder | 1472.559 cubic centimeter (cm^3) | Standard Deviation 59.95 |
| Cohort A | Total Brain Volume | Non-responder | 1417.431 cubic centimeter (cm^3) | Standard Deviation 109.8668 |