CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 291 enrolled
Drug / intervention
Cladribine Tabletsdrug
Likely dose
Cladribine Tablets 3.5 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03933202
NCT03933202N/ACompleted
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Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

EMD Serono Research & Development Institute, Inc.·observational·Posted May 1, 2019·Updated Jan 2, 2026

In Brief

An observational study evaluating Cladribine Tablets for Multiple Sclerosis. Completed, enrolled 291 participants across 66 sites.

Detailed Summary

To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion Disease-Modifying Drugs (DMDs) approved in the United States (US) for RMS in a real-world-setting.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis
CountriesUnited States
CollaboratorsMerck KGaA, Darmstadt, Germany

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMay 1, 2019
Enrollment StartJul 22, 2019
Primary CompletionNov 11, 2024
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 7.2 years ago

Interventions

Cladribine Tabletsdrug

No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.