Cladribine tablets: Observational evaluation of effectiveness and patient-reported outcomes (PROs) in suboptimally controlled patients previously taking oral disease-modifying drugs (DMDs) for relapsing forms of multiple sclerosis (RMS)
The MS Center at EvergreenHealth is conducting a study is to evaluate the effectiveness and safety of cladribine tablets in participants with relapsing form of multiple sclerosis (RMS) and active secondary progressive multiple sclerosis (SPMS) who transition to cladribine tablets after suboptimal response to any oral DMD approved in the United States for RMS in a real-world setting.
Who may be eligible to participate?
Male or female patients, age 18 years or older who have been diagnosed with RMS, including RRMS and active SPMS, and satisfy the approved indication for cladribine tablets; must have experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral DMD treatment other than cladribine tablets. Other inclusion/exclusion criteria apply.
What does participation involve?
Patients will attend study visits as per routine clinical practice, which are expected to happen approximately at the end of Month 2, Month 6 and Month 12 during Year 1, and at the end of Month 14, 18, and 24 (during Year 2), as clinically indicated. Detailed clinical data about MS disease relapses, MRI findings, hematologic and other laboratory assessments, medications received, and adverse events, as well as Patient-Reported Outcomes, will be prospectively collected.
Theodore Brown, MD, MPH, EvergreenHealth MS Center