A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)

• Register: ClinicalTrials.gov
• Last refreshed on: 4 March 2024
• Main ID: NCT03933202
• Date of registration: 29/04/2019
• Prospective Registration: Yes
• Primary sponsor: EMD Serono Research & Development Institute, Inc.
• Public title: A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
• Scientific title: Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
• Date of first enrolment: July 22, 2019
• Target sample size: 295
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03933202
• Study type: Observational

Countries of recruitment

United States

Contacts

• Name: Medical Responsible
• Affiliation: EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Cladribine Tablets

Primary Outcome(s)

Annualized Relapse Rate (ARR) (Prospective Assessment) [Time Frame: Baseline (Month 0) up to 24 Months]

Secondary Outcome(s)

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24 [Time Frame: Baseline (Month 0), Month 6, 12 and 24]

Percentage of Participants With Reason for Discontinuation of Cladribine Tablets [Time Frame: Baseline (Month 0) up to 24 Months]

Annualized Relapse Rate (ARR) (Retrospective Assessment) [Time Frame: Up to 24 Months prior Baseline (Month 0)]

Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24 [Time Frame: Baseline (Month 0), Month 6, 12 and 24]

Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 [Time Frame: Baseline (Month 0), Month 6, 12 and 24]

Percentage of Participants Who Discontinue Cladribine Tablets [Time Frame: Baseline (Month 0) up to 24 Months]

Percentage of Participants With Relapse Associated With Glucocorticoid Use [Time Frame: Month 12 and 24]

Elapsed Time to Discontinuation After First Dose of Cladribine Tablets [Time Frame: Baseline (Month 0) up to 24 Months]

Percentage of Planned Doses Received by Participants as per United States Prescribing Information [Time Frame: Baseline (Month 0) up to 24 Months]

Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24 [Time Frame: Baseline (Month 0), Month 6, 12 and 24]

Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 [Time Frame: Baseline (Month 0), Month 6, 12 and 24]

Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24 [Time Frame: Baseline (Month 0), Month 6, 12 and 24]

Number of Doses Received by Participants as per United States Prescribing Information [Time Frame: Baseline (Month 0) up to 24 Months]

Percentage of Participants with Relapse (Prospective Assessment) [Time Frame: Month 12 and 24]

Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization [Time Frame: Month 12 and 24]

Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period [Time Frame: Baseline (Month 0) up to 24 Months]

Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) [Time Frame: Baseline (Month 0) and at the end of Months 1, 2, 13 and 14]

Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations [Time Frame: Baseline (Month 0) up to 24 months]

Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets [Time Frame: Baseline (Month 0) up to 24 Months]

Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS) [Time Frame: At Baseline (Month 0)]

Secondary ID(s)

MS700568_0079

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck KGaA, Darmstadt, Germany