N/A
N=283
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT03933202 ↗Enrolled (actual)
283
Serious AEs
12.8%
Results posted
Jan 2026
Primary outcome: Primary: Annualized Relapse Rate (ARR) — 0.04; 0.03 relapses per year
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cladribine Tablets (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- EMD Serono Research & Development Institute, Inc.
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) |
0.04; 0.03 | — |
| SECONDARY Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 |
18.5; 22.2; 11.1; 19.0; 16.1; -28.6 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 |
44.2; 38.1; 0.4; 2.2; 0.2; -1.9 | — |
| SECONDARY Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 |
9.0; 10.5; 0.0; -0.8; -0.3; 1.5 | — |
| SECONDARY Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 |
1.8; 3.5; 0.5; 1.0; 0.2; 1.0 | — |
| SECONDARY Change From Baseline in Percentage of Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 |
0.0; -8.7; -7.7; 30.8; 0.00; -100.0 | — |
| SECONDARY Change From Baseline in Percentage of Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 |
-10.0; -10.0; -10.0; 0.0; -1.7 | — |
| SECONDARY Change From Baseline in Percentage of Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 |
-10.0; -10.0; -9.8; 0.0; -1.7 | — |
| SECONDARY Change From Baseline in Percentage of Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24 |
3.5; -8.9; -12.2; 10.0; 0.0; -10.0 | — |
| SECONDARY Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 |
2.1; 3.4; -0.1; -0.4; 0.0; -0.1 | — |
| SECONDARY Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) |
71; 50; 72; 53; 32; 22 | — |
| SECONDARY Number of Participants Who Experienced Relapse |
4; 4; 6; 4 | — |
| SECONDARY Percentage of Participants With Relapse Associated With Hospitalization |
1.0; 0.0; 0; 0.0; 1.0; 0.0 | — |
| SECONDARY Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 |
0.01; 0.00; 0.01; 0.00 | — |
| SECONDARY Percentage of Participants With Relapse Associated With Glucocorticoid Use |
1.0; 3.5; 1.0; 0.0; 1.9; 2.4 | — |
| SECONDARY Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 |
0.01; 0.04; 0.02; 0.03 | — |
| SECONDARY Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline |
3.0; 3.4 | — |
| SECONDARY Percentage of Participants Who Discontinued Cladribine Tablets |
41.7; 22.4 | — |
| SECONDARY Number of Participants With Reason for Discontinuation of Cladribine Tablets |
9; 1; 12; 6; 4; 2 | — |
| SECONDARY Elapsed Time to Discontinuation After First Dose of Cladribine Tablets |
12.8; 13.1 | — |
| SECONDARY Number of Doses Received by Participants as Per United States Prescribing Information |
24.0; 25.0 | — |
| SECONDARY Total Planned Doses Received by Participants as Per United States Prescribing Information |
3.4; 3.5 | — |
| SECONDARY Percentage of Participants With Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets |
4.7; 5.2 | — |
| SECONDARY Number of Participants With At Least One Concomitant Medication |
98; 73 | — |
| SECONDARY Annualized Relapse Rate (ARR) |
0.04; 0.03 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) |
65; 51; 10; 14; 35; 19 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
- Have time since diagnosis of RMS of at least 12 months
- In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets
- Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD
- Have decided to initiate treatment with cladribine tablets during routine clinical care
- Meet criteria as per the approved USPI
- Have access to a valid e-mail address
Exclusion Criteria
- Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral)
- Transitioning from previous oral DMD solely for administrative reasons such as relocation
- Have comorbid conditions that preclude participation
- Have any clinical condition or medical history noted as contraindication on USPI
- Are currently participating in an interventional clinical trial
- Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period
Data sourced from ClinicalTrials.gov (NCT03933202). 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.