Trial Outcomes & Findings for Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS) (NCT NCT04997148)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

116 participants

Primary outcome timeframe

1 Year prior to date of Cladribine tablet initiation

Results posted on

2024-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Cladribine Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Overall Study STARTED	116
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Age, Continuous	44 Years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	82 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	116 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year prior to date of Cladribine tablet initiation

Population: Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets.

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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets	0.595 Relapse per year Interval 0.47 to 0.753

PRIMARY outcome

Timeframe: Year 1 after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets	0.101 Relapse per year Interval 0.052 to 0.194

PRIMARY outcome

Timeframe: Year 2 after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Annualized Relapse Rate in the Year 2 After Treatment Initiation With Cladribine Tablets	0.052 Relapse per year Interval 0.023 to 0.115

PRIMARY outcome

Timeframe: Year 3 after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Annualized Relapse Rate in the Year 3 After Treatment Initiation With Cladribine Tablets	0.086 Relapse per year Interval 0.046 to 0.16

PRIMARY outcome

Timeframe: Year 4 after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Annualized Relapse Rate in the Year 4 After Treatment Initiation With Cladribine Tablets	0.060 Relapse per year Interval 0.046 to 0.16

PRIMARY outcome

Timeframe: Year 5 after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Annualized Relapse Rate in the Year 5 After Treatment Initiation With Cladribine Tablets	0.063 Relapse per year Interval 0.024 to 0.169

SECONDARY outcome

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

Population: Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure and "number analyzed" signifies those participants who were evaluable at specified time points for this outcome measure.

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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment Year 1	0.92 estimated probability Interval 0.8 to 0.97
Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment Year 2	0.85 estimated probability Interval 0.72 to 0.93
Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment Year 3	0.81 estimated probability Interval 0.67 to 0.9
Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment Year 4	0.78 estimated probability Interval 0.63 to 0.87
Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment Year 5	0.75 estimated probability Interval 0.58 to 0.86

SECONDARY outcome

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

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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.

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Time From Cladribine Tablet Initiation to First Relapse	NA years Median time to relapse and CI was not reached due to insufficient number of participants with events.

SECONDARY outcome

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

Population: Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets.

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

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Number of Participants Who Discontinued Cladribine Tablets	4 Participants

SECONDARY outcome

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

Population: Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets.

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

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion	19 Participants

SECONDARY outcome

Timeframe: At Treatment Initiation and Start of Treatment Year 2

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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).

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2	0 Participants

SECONDARY outcome

Timeframe: At 2 years after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment 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).

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
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	0 Participants

SECONDARY outcome

Timeframe: At 2 years after treatment initiation with Cladribine tablets

Population: Full Analysis Set included all participants who were treated with at least one course of treatment with cladribine tablets.

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

Outcome measures

Outcome measures
Measure	Cladribine n=116 Participants Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies Serious/opportunistic infections	8 Participants
Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies Grade 3 Lymphopenia	47 Participants
Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies Grade 4 Lymphopenia	0 Participants
Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies Herpes infections	6 Participants
Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies Malignancies	1 Participants

Adverse Events

Cladribine

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cladribine n=116 participants at risk Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.86% 1/116 • Number of events 1 • Up to 2 years

Other adverse events

Other adverse events
Measure	Cladribine n=116 participants at risk Participants diagnosed with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.
Blood and lymphatic system disorders Lymphopenia	40.5% 47/116 • Number of events 47 • Up to 2 years
Infections and infestations Herpes simplex	0.86% 1/116 • Number of events 1 • Up to 2 years
Infections and infestations Herpes zoster	3.4% 4/116 • Number of events 4 • Up to 2 years
Infections and infestations Nasopharyngitis	0.86% 1/116 • Number of events 1 • Up to 2 years
Infections and infestations Onychomycosis	0.86% 1/116 • Number of events 1 • Up to 2 years
Infections and infestations Oral herpes	0.86% 1/116 • Number of events 1 • Up to 2 years
Infections and infestations Urinary tract infection	1.7% 2/116 • Number of events 2 • Up to 2 years

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place