NCT04934800

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 256 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Cladribine	No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.

Timeline

• Start date: 2019-12-10
• Primary completion: 2024-05-20
• Completion: 2024-05-20
• First posted: 2021-06-22
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

61 sites across 7 countries: Austria, Greece, Italy, Norway, Poland, Portugal, Switzerland