Relapsing-Remitting Multiple SclerosisNCT04997148

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

An observational study of Relapsing-Remitting Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 8 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
Type of treatment: Pill or oral medicine
How many people: 116 participants
Where: 8 sitesUnited Kingdom
Study dates: 11 Aug 2021to 14 Sep 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Participants with HDA-RRMS who initiated treatment with cladribine tablets.

Who may be able to join

Physician diagnosis of HDA-RRMS as defined by clinical or radiological features
Treatment initiation with cladribine tablet monotherapy on or after 22 August 2017 and at least 3 years before enrolment
Completion of Year 1 treatment of cladribine tablets (Week 1 and Week 2 treatment, per recommended dose in Year 1: 1.75 milligrams per kilogram [mg/kg] body weight, cumulatively)

Who cannot join

Received cladribine tablet treatment within an interventional clinical trial during the study period
Received treatment with any investigational therapy for RRMS in the 6 months prior to cladribine tablet treatment initiation

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United Kingdom8 sites

University Hospitals Coventry and Warwickshire- Neurology
Coventry
NHS Lanarkshire Health Board- Department of Neurology
Glasgow
Queen Elizabeth University Hospital
Glasgow
University Hospitals of Leicester NHS Trust
Leicester
Barking Havering and Redbridge University Hospitals NHS Trust
London
University College London UCL
London
Nottingham City Hospital (2655)
Nottingham
Salford Royal
Salford

Other trials in United Kingdom

About this study

Official title: Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)

The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.

Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis, Mavenclad ®, Cladribine
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04997148
Study group	Role	What they receive
Cladribine		No intervention was administered as a part of this study. Participants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Annualized Relapse Rate in the Year Prior to 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 the year prior to the date of Cladribine tablet initiation.
Measured: 1 Year prior to date of Cladribine tablet initiation
Annualized Relapse Rate in the Year One 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.
Measured: Year 1 after treatment initiation with Cladribine tablets
Annualized Relapse Rate in the 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.
Measured: Year 2 after treatment initiation with Cladribine tablets
Annualized Relapse Rate in the 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.
Measured: Year 3 after treatment initiation with Cladribine tablets
Annualized Relapse Rate in the 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.
Measured: Year 4 after treatment initiation with Cladribine tablets
Annualized Relapse Rate in the 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.
Measured: Year 5 after treatment initiation with Cladribine tablets

Secondary outcomes (7)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At 2 years after treatment initiation with Cladribine tablets

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Aug 202114 Sep 2023

First posted9 Aug 2021
Study start11 Aug 2021
Primary completion14 Sep 2023
Study completion14 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 116 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04997148
Sponsor's protocol ID: MS700568_0150
Status last verified: Dec 2024
First submitted: 3 Aug 2021
Last updated: 18 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)
ClinicalTrials.gov ID: NCT04997148
Acronym / sponsor ID: MS700568_0150
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis, Mavenclad ®, Cladribine
Study type: Observational
Recruitment status: Completed
Enrolment: 116 participants (actual)
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Collaborators: Merck Serono Limited, UK
Study start: 11 Aug 2021 (actual)
Primary completion: 14 Sep 2023 (actual)
Study completion: 14 Sep 2023 (actual)
First posted: 9 Aug 2021 (actual)
Results: Posted 18 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Cladribine	–	–No intervention was administered as a part of this study. Participants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Participants with HDA-RRMS who initiated treatment with cladribine tablets.

Key inclusion criteria (3 listed)

Physician diagnosis of HDA-RRMS as defined by clinical or radiological features
Treatment initiation with cladribine tablet monotherapy on or after 22 August 2017 and at least 3 years before enrolment
Completion of Year 1 treatment of cladribine tablets (Week 1 and Week 2 treatment, per recommended dose in Year 1: 1.75 milligrams per kilogram [mg/kg] body weight, cumulatively)

Key exclusion criteria (2 listed)

Received cladribine tablet treatment within an interventional clinical trial during the study period
Received treatment with any investigational therapy for RRMS in the 6 months prior to cladribine tablet treatment initiation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets
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.
Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets
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.
Annualized Relapse Rate in the Year 2 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.
Annualized Relapse Rate in the Year 3 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.
Annualized Relapse Rate in the Year 4 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.
Annualized Relapse Rate in the Year 5 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.

7 secondary outcomes

Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment
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
Time frame: up to maximum 5 years after treatment initiation with Cladribine tablets
Number of Participants Who Discontinued Cladribine Tablets
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
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
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
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
Time frame: At 2 years after treatment initiation with Cladribine tablets

Results and safety

Results posted to the registry on 18 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cladribine	116	116

Primary outcome: Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets

Time frame: 1 Year prior to date of Cladribine tablet initiation. Mean (95% Confidence Interval). Unit: Relapse per year

Measure	Cladribine n = 116
Value	0.595 (0.470 to 0.753)

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

Primary outcome: Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets

Time frame: Year 1 after treatment initiation with Cladribine tablets. Mean (95% Confidence Interval). Unit: Relapse per year

Measure	Cladribine n = 116
Value	0.101 (0.052 to 0.194)

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

Primary outcome: Annualized Relapse Rate in the Year 2 After Treatment Initiation With Cladribine Tablets

Time frame: Year 2 after treatment initiation with Cladribine tablets. Mean (95% Confidence Interval). Unit: Relapse per year

Measure	Cladribine n = 116
Value	0.052 (0.023 to 0.115)

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

Primary outcome: Annualized Relapse Rate in the Year 3 After Treatment Initiation With Cladribine Tablets

Time frame: Year 3 after treatment initiation with Cladribine tablets. Mean (95% Confidence Interval). Unit: Relapse per year

Measure	Cladribine n = 116
Value	0.086 (0.046 to 0.160)

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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 2 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cladribine	1 of 116 (0.9%)	51 of 116 (44%)	0 of 116

Limitations and caveats (from the sponsor): Potential limitations include the retrospective study design, and that data was limited by control over patient assessment as patient monitoring and diagnostics were per standard of care.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Trial Awareness and Transparency websiteLink provided by the sponsor.
Medical Information Location Map - Med Info ContactsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Responsible study director

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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsing-Remitting Multiple Sclerosis, run by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany at 8 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets (time frame: 1 Year prior to date of Cladribine tablet initiation). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04997148.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.