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

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03933215

Run by

EMD Serono Research & Development Institute, Inc.

People needed

100

Starts

2019-05-21

Expected to finish

2024-03-30

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• HCA Research Institute — Englewood, Colorado, United States
• Advanced Neurosciences Research — Fort Collins, Colorado, United States
• Prairie Education & Research — Springfield, Illinois, United States
• Fort Wayne Neurological Center — Fort Wayne, Indiana, United States
• College Park Family Care Center — Overland Park, Kansas, United States
• The Elliot Lewis Center for Multiple Sclerosis Care, LLC — Wellesley, Massachusetts, United States
• UMASS - Neurology — Worcester, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Memorial Healthcare — Owosso, Michigan, United States
• Minneapolis Clinic of Neurology - Neurology — Minneapolis, Minnesota, United States
• Guilford Neurologic Associates — Greensboro, North Carolina, United States
• Neurology Center of San Antonio — San Antonio, Texas, United States
• Blacksburg Neurology, PC — Christiansburg, Virginia, United States
• Neurological Associates — Richmond, Virginia, United States
• VCU Medical Center - Pediatric Neurology — Richmond, Virginia, United States
• Sentara Ambulatory Care Center — Virginia Beach, Virginia, United States
• MS Center of Evergreen — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.