N/A
N=256
Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT04934800 ↗Enrolled (actual)
256
Serious AEs
3.9%
Results posted
Jun 2025
Primary outcome: Primary: 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) — -1.12 relapses per year
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cladribine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
-1.12 | — |
| SECONDARY Change in ARR Between the Pre-Baseline 12-Month Period (Baseline) and Over the 12 Months Period After the Start of Cladribine (1 Year) |
-1.01 | — |
| SECONDARY Percentage of Participants With 6-Month Disability Progression Measured With Expanded Disability Status Scale (EDSS) |
1.6 | — |
| SECONDARY Percentage of Participants With Overall 6-Month Disability Progression Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test (9HPT) |
4.7 | — |
| SECONDARY Percentage of Participants With 6-Month Disability Improvement Measured With EDSS |
1.6 | — |
| SECONDARY Percentage of Participants With Overall 6-Month Disability Improvement Measured With EDSS, Timed 25 Foot Walk (T25FW) or 9 Hole Peg Test(9HPT) |
4.7 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
90; 10 | — |
| SECONDARY Quality of Life as Assessed by Multiple Sclerosis Impact Scale (MSIS-29) Score: Physical and Psychological Impact |
30.8; 24.8; 23.7; 20.1; 17.4; 17.2 | — |
| SECONDARY Quality of Life as Assessed by EuroQol Quality of Life Questionnaire 5 Dimensions 3 Levels (EQ-5D-3L) |
73.6; 78.9; 78.4 | — |
| SECONDARY Treatment Satisfaction as Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale |
71.3; 75.4; 75.0; 77.2; 71.7; 72.6 | — |
| SECONDARY Number of Participants With Treatment Adherence |
232; 2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04934800). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.