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NCT03933215Completed

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

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

Source: ClinicalTrials.gov · Last updated 29 Apr 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
100 (actual)
First submitted
29 Apr 2019
Start date
21 May 2019
Primary completion date
30 Mar 2024
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT03933215

What you commit to

  • Study type: Observational
  • Participants enrolled: 100
  • From 21 May 2019 to the primary completion date, 30 Mar 2024
  • 18 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Have been previously treated with cladribine in any dosing form
  • Transitioning from previous injectable DMD solely for administrative reasons such as relocation

Other illness

  • Have comorbid conditions that preclude participation
  • Have any clinical condition or medical history noted as contraindication on USPI

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (18)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Blacksburg Neurology, PC
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ChristiansburgUnited StatesUnknown status
Henry Ford Health System
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DetroitUnited StatesUnknown status
HCA Research Institute
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EnglewoodUnited StatesUnknown status
Advanced Neurosciences Research
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Fort CollinsUnited StatesUnknown status
Fort Wayne Neurological Center
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Fort WayneUnited StatesUnknown status
Guilford Neurologic Associates
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GreensboroUnited StatesUnknown status
MS Center of Evergreen
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KirklandUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Minneapolis Clinic of Neurology - Neurology
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MinneapolisUnited StatesUnknown status
College Park Family Care Center
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Overland ParkUnited StatesUnknown status
Memorial Healthcare
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OwossoUnited StatesUnknown status
VCU Medical Center - Pediatric Neurology
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RichmondUnited StatesUnknown status
Neurological Associates
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RichmondUnited StatesUnknown status
Neurology Center of San Antonio
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San AntonioUnited StatesUnknown status
Prairie Education & Research
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SpringfieldUnited StatesUnknown status
Sentara Ambulatory Care Center
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Virginia BeachUnited StatesUnknown status
The Elliot Lewis Center for Multiple Sclerosis Care, LLC
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WellesleyUnited StatesUnknown status
UMASS - Neurology
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WorcesterUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.