A Study of Suboptimally Controlled Participants Previously Taking Injectable Disease-modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS)
Purpose
To evaluate the effectiveness and safety 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 injectable DMD approved in the United States (US) for RMS in a real-world setting.
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female participants greater than or equal to (>=)18 years
- 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
- Had received their last previous injectable disease-modifying drug (DMD) for at least 3 months
- 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
- In the opinion of the Investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to injectable DMD treatment
Exclusion Criteria
- Have been previously treated with cladribine in any dosing form
- Transitioning from previous injectable 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 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 injectable 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
UK Center for Clinical and Translational Science and nearby locations
University of Kentucky - Department of Neurology
Lexington, Kentucky 40536
Lexington, Kentucky 40536
More Details
- NCT ID
- NCT03933215
- Status
- Recruiting
- Sponsor
- EMD Serono Research & Development Institute, Inc.