A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
Purpose
To evaluate the effectiveness, patient-reported outcomes (PROs) and safety of cladribine tablets in participants with relapsing forms of multiple sclerosis (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 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
- 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 |
|
Recruiting Locations
More Details
- NCT ID
- NCT03933215
- Status
- Completed
- Sponsor
- EMD Serono Research & Development Institute, Inc.