Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)

Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment

Relapse-free is defined as the time from the on-treatment period start date until first relapse or death as assessed by the investigator. Relapse-free rate, i.e., the survival rate using Kaplan Meier method, was summarized every year.

Time frame: Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death

Time From Cladribine Tablet Initiation to First Relapse

A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of participants with qualified relapse-free status at week 24 were reported.

Time frame: up to maximum 5 years after treatment initiation with Cladribine tablets

Number of Participants Who Discontinued Cladribine Tablets

The number of participants who discontinued treatment with cladribine are reported here.

Time frame: From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)

Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion

The number of participants who received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion were reported here.

Time frame: From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)

Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2

he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis \[MS\]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS).

Time frame: At Treatment Initiation and Start of Treatment Year 2

Number of Participants With Disability Progression Confirmed Over 6 Months, Assessed by Expanded Disease Severity Scale (EDSS) at 2 Years After Cladribine Tablet Treatment Initiation

he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis \[MS\]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS).

Time frame: At 2 years after treatment initiation with Cladribine tablets

Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies

Number of Participants with Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies were reported.

Time frame: At 2 years after treatment initiation with Cladribine tablets