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A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)

CompletedN/A

Sponsor: EMD Serono Research & Development Institute, Inc.

Conditions: Multiple Sclerosis

Interventions: Cladribine

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (18)

Little Rock, Arkansas, United States
Englewood, Colorado, United States
Fort Collins, Colorado, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Overland Park, Kansas, United States
Wellesley, Massachusetts, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Owosso, Michigan, United States
Minneapolis, Minnesota, United States
Greensboro, North Carolina, United States
San Antonio, Texas, United States
Christiansburg, Virginia, United States
Richmond, Virginia, United States
Richmond, Virginia, United States
Virginia Beach, Virginia, United States
Kirkland, Washington, United States