Special Drug-use Surveillance for Kesimpta for s.c. Injection 20 mg Pen
NCT04940065
Active Secondary Progressive Multiple Sclerosis, Autoimmune Diseases
Ichinomiya, Aichi-ken, Japan
View Trial DetailsNCT Number: NCT04997148
The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.
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Notify Me18 year and older
All sexes
Observational
University Hospitals Coventry and Warwickshire- Neurology, Coventry, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 Year prior to date of Cladribine tablet initiation
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in the year prior to the date of Cladribine tablet initiation.
Time frame: Year 1 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 1 after treatment initiation with Cladribine tablets.
Time frame: Year 2 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 2 after treatment initiation with Cladribine tablets.
Time frame: Year 3 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 3 after treatment initiation with Cladribine tablets.
Time frame: Year 4 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 4 after treatment initiation with Cladribine tablets.
Time frame: Year 5 after treatment initiation with Cladribine tablets
The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 5 after treatment initiation with Cladribine tablets.
Time frame: Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death
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: up to maximum 5 years after treatment initiation with Cladribine tablets
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: From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
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)
The number of participants who received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion were reported here.
Time frame: 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 2 years after treatment initiation with Cladribine tablets
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 were reported.
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Industry
Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)
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