MSFrontier

Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)
CompletedRelapsing MSNCT04934800

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

Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period Before the End of Study Follow-Up (2 Years)

12-months pre-baseline (Baseline) and 12 Months Prior to End of Study follow up (2 years)

GroupValueIntervalNumber analysed
Cladribine-1.12 relapses per year-1.23–-1221

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

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Cladribine25610 (3.9%)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

  • Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period Before the End of Study Follow-Up (2 Years)

    12-months pre-baseline (Baseline) and 12 Months Prior to End of Study follow up (2 years)

    Relapses

Other measures (10)

  • Change in ARR Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period After the Start of Cladribine (1 Year)

    12-month pre-baseline period (baseline) and over the 12 months period after start of Cladribine treatment (1 year)

    Relapses

  • Percentage of Participants With 6-Month Disability Progression Measured With Expanded Disability Status Scale (EDSS)

    At EOS (24 months follow-up)

    Disability progressionWalking and mobility

  • Percentage of Participants With Overall 6-Month Disability Progression Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test (9HPT)

    At EOS (24 months follow-up)

    Disability progressionWalking and mobility

  • Percentage of Participants With 6-Month Disability Improvement Measured With EDSS

    At EOS (24 months follow-up)

    Disability progressionWalking and mobility

  • Percentage of Participants With Overall 6-Month Disability Improvement Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test(9HPT)

    At EOS (24 months follow-up)

    Disability progressionWalking and mobility

  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    From start of study up to 2 years

    Safety

  • Quality of Life as Assessed by Multiple Sclerosis Impact Scale (MSIS-29) Score: Physical and Psychological Impact

    Baseline, Months 12 and 24

    Quality of life (reported by participants)

  • Quality of Life as Assessed by EuroQol Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D-3L)

    Baseline, Months 12 and 24

    Walking and mobilityPainMood and sleepQuality of life (reported by participants)

  • Treatment Satisfaction as Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale

    Months 6, 12, 18 and 24

    Quality of life (reported by participants)Safety

  • Number of Participants With Treatment Adherence

    Up to Month 24

    Quality of life (reported by participants)

Who could take part

Relapsing MS · 18 and over

Inclusion Criteria: * Participants with confirmed diagnosis of RRMS diagnosed by the treating physician according to applicable clinical practice guidelines -(currently McDonald 2017 criteria), with high disease activity * Participants should have been treated with the same first-line DMD (Interferons, Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year prior to switch to Cladribine tablets and should have been prescribed Cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. Any washout period and/or washout methods required before switching (such as elimination of Teriflunomide) must have been conducted, according to the decision of the treating physician * Required history data should be available: Multiple Sclerosis (MS) data for the 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior DMDs) * Fulfilment of the criteria for treatment with Cladribine tablets per standard of care in accordance with the local Summary of Product Characteristics (SmPC) Exclusion Criteria: * Contraindications to use of cladribine tablets according to the SmPC * Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study * Participants that have received Cladribine in the past * Concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol

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

About this trial

In the sponsor's words

The main aim was to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) [DMF]) to treatment with Cladribine tablets in routine clinical practice.

Papers

    Loading reviews and guidelines…

    Related trials

    History

      1. Started

        Dec 2019

      2. Main results due

        May 2024

      3. Finished

        May 2024

      4. Results posted

        Jun 2025

      Assembled by software from public sources and not checked by people. Each record links to its source. Report an error