MSFrontier

CLARIFY MS Extension

A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)
CompletedPhase 4Relapsing MSNCT047762132020-003874-30

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Results by group

Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48

Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)

GroupValueIntervalNumber analysed
Mavenclad®68.6 percentage of participants62.9–73.7280

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Mavenclad®28015 (5.4%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 Points or Less in the SDMT Score, From Baseline of Parent Study to Month 48

    Baseline (Baseline of parent study [NCT03369665]) and Month 48 after initial dose of Mavenclad® in parent study (NCT03369665)

    Thinking and memory

  • Percentage of participants with no or minimal decline in cognitive function, defined as an improved or stable Symbol Digit Modalities Test (SDMT) scorea or a decline of 4 points or less in the SDMT score, at 4 years after initial dose of cladribine tablets (M48) compared to SDMT score prior to initial dose of cladribine tablets (CLARIFY MS Baseline)

    Thinking and memory

Other measures (3)

  • Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years

    Baseline (baseline of parent study [NCT03369665]), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

  • Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Composite Summary Scores at 4 Years

    Month 24 after initial dose of Mavenclad® in parent study (NCT03369665), 4 years after initial dose of Mavenclad® in parent study (NCT03369665)

    Thinking and memoryBladder, bowel and sexual functionPainQuality of life (reported by participants)

  • • Change in HRQoL as measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) physical and mental health scores at 4 years after initial dose of cladribine tablets (M48) compared to prior to initial dose of cladribine tablets (CLARIFY MS Baseline)

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: * Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT) * Received at least a single dose of cladribine tablets in the CLARIFY MS study * Completed the Final Study Visit (M24) of the CLARIFY MS study * Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol Exclusion Criteria: * Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study * Participation in other studies.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The purpose of the study was the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This was the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

Papers

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Linked trials

Links found where a registry record names another trial's registry number.

Related trials

History

    1. Started

      Feb 2021

    2. Main results due

      Jun 2023

    3. Finished

      Jun 2023

    4. Results posted

      May 2024

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