Multiple Sclerosis Clinical Trial

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

Summary

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

100

Study ID:

NCT03933215

Recruitment Status:

Active, not recruiting

Sponsor:

EMD Serono Research & Development Institute, Inc.

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There are 17 Locations for this study

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University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
HCA Research Institute
Englewood Colorado, 80113, United States
Advanced Neurosciences Research
Fort Collins Colorado, 80528, United States
Prairie Education & Research
Springfield Illinois, 62702, United States
Fort Wayne Neurological Center
Fort Wayne Indiana, 46804, United States
College Park Family Care Center
Overland Park Kansas, 66212, United States
The Elliot Lewis Center for Multiple Sclerosis Care, LLC
Wellesley Massachusetts, 02481, United States
UMASS - Neurology
Worcester Massachusetts, 01655, United States
Henry Ford Health System
Detroit Michigan, 48202, United States
Memorial Healthcare
Owosso Michigan, 48867, United States
Minneapolis Clinic of Neurology - Neurology
Minneapolis Minnesota, 55422, United States
Guilford Neurologic Associates
Greensboro North Carolina, 27405, United States
Neurology Center of San Antonio
San Antonio Texas, 78258, United States
Blacksburg Neurology, PC
Christiansburg Virginia, 24073, United States
Neurological Associates
Richmond Virginia, 23229, United States
Sentara Ambulatory Care Center
Virginia Beach Virginia, 23456, United States
MS Center of Evergreen
Kirkland Washington, 98034, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

100

Study ID:

NCT03933215

Recruitment Status:

Active, not recruiting

Sponsor:


EMD Serono Research & Development Institute, Inc.

How clear is this clinincal trial information?

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