A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Purpose
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.
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Cladribine Tablets | No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any oral or infusion DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI). Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03933202
- Status
- Completed
- Sponsor
- EMD Serono Research & Development Institute, Inc.