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CLASSIC-MS

Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)
CompletedPhase 4Relapsing MSNCT039612042019-000069-19

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 Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher

3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)

GroupValueIntervalNumber analysed
Cohort A8.2 percentage of participant6.2–10.6636

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Cohort A6621 (0.2%)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 Using Wheelchair or Being Bedridden Assessed by Expanded Disability Status Scale (EDSS) Score 7.0 or Higher

    3 months prior to study visit 1. Retrospectively from end of parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)

    Disability progressionWalking and mobility

  • Proportion of study participants using a wheelchair (defined as unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and

    Walking and mobility

Other measures (11)

  • Percentage of Participants With Expanded Disability Status Scale (EDSS) Score 6.0 or Higher

    At study visit 1. Retrospectively after last IMP administration from parent study (NCT00213135, NCT00641537 and NCT00725985) to study visit 1 (study visit 1 occurred up to 3 months from screening)

    Disability progressionWalking and mobility

  • Clinical and Demographic Characteristic: Age, Disease Duration

    At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  • Number of Participants in Each Category of Clinical and Demographic Characteristics

    At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

  • Clinical Characteristic: Expanded Disability Status Scale (EDSS) Score

    At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    Disability progressionWalking and mobility

  • Clinical Characteristic: Number of Relapses

    At study visit 1, occurred up to 3 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    Relapses

  • Number of Total T1-weighted (T1-W) Lesions

    At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    MRI lesions

  • Number of Total T2-weighted (T2-W) Lesions

    At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    MRI lesions

  • T1-weighted (T1-W) Lesion Volume

    At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    MRI lesions

  • T2-weighted (T2-W) Lesion Volume

    At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    MRI lesions

  • Total Brain Volume

    At study visit 2, within 6 months from screening (Retrospective analysis of medical record of parent study-NCT00213135, NCT00641537 and NCT00725985)

    MRI lesionsBrain volume loss

Who could take part

Relapsing MS · 18 to 65

Inclusion Criteria: * Participants with relapsing remitting multiple sclerosis (RRMS) randomised in CLARITY/CLARITY-EXT clinical trial(s) who have received greater than or equal to (>=) 1 course of in investigational medicinal product (IMP) Cladribine Tablets or placebo * Participants with their first clinical demyelinating event randomised in ORACLE MS clinical trial who have received >= 1 course of IMP Cladribine Tablets or placebo * Participants who has sign informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol Exclusion Criteria: * Participants who has any uncontrolled disease state other than MS, that in the Investigator's opinion, constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation * For study participants at selected sites where MRI assessment will be conducted following exclusion criteria will apply to MRI assessments only: * Female study participants who are pregnant * Participants who are taking Cladribine Tablets as part of another study at the time of the start of this study

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

About this trial

In the sponsor's words

The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

Papers

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History

    1. Started

      Aug 2019

    2. Main results due

      Feb 2021

    3. Finished

      May 2021

    4. Results posted

      May 2022

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