Cladribine Tablets: Observational Evaluation of Effectiveness and Patient-Reported Outcomes (PROs) in Suboptimally Controlled Patients Previously Taking Injectable Disease-Modifying Drugs (DMDs) for Relapsing Forms of Multiple Sclerosis (RMS) (CLICK-MS)
Sponsor:
Brief Summary:
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.
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
Locations
- Regina Berkovich MD PhD INC, West Hollywood, California, United States, 90048
