Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)

Status: Completed
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arkansas
University of Arkansas for Medical Sciences
Little Rock
Colorado
HCA Research Institute
Englewood
Advanced Neurosciences Research
Fort Collins
Illinois
Prairie Education & Research
Springfield
Indiana
Fort Wayne Neurological Center
Fort Wayne
Kansas
College Park Family Care Center
Overland Park
Massachusetts
The Elliot Lewis Center for Multiple Sclerosis Care, LLC
Wellesley
UMASS - Neurology
Worcester
Michigan
Henry Ford Health System
Detroit
Memorial Healthcare
Owosso
Minnesota
Minneapolis Clinic of Neurology - Neurology
Minneapolis
North Carolina
Guilford Neurologic Associates
Greensboro
Texas
Neurology Center of San Antonio
San Antonio
Virginia
Blacksburg Neurology, PC
Christiansburg
Neurological Associates
Richmond
VCU Medical Center - Pediatric Neurology
Richmond
Sentara Ambulatory Care Center
Virginia Beach
Washington
MS Center of Evergreen
Kirkland
Time Frame
Start Date: 2019-05-21
Completion Date: 2024-03-30
Participants
Target number of participants: 100
Treatments
Cladribine
Related Therapeutic Areas
Sponsors
Collaborators: Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.

This content was sourced from clinicaltrials.gov