- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03933215
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
December 12, 2023 updated by: EMD Serono Research & Development Institute, Inc.
Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
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Colorado
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Englewood, Colorado, United States, 80113
- HCA research Institute
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Fort Collins, Colorado, United States, 80528
- Advanced Neurosciences Research
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Illinois
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Springfield, Illinois, United States, 62702
- Prairie Education & Research
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Fort Wayne Neurological Center
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Kansas
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Overland Park, Kansas, United States, 66212
- College Park Family Care Center
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Massachusetts
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Wellesley, Massachusetts, United States, 02481
- The Elliot Lewis Center for Multiple Sclerosis Care, LLC
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Worcester, Massachusetts, United States, 01655
- UMASS - Neurology
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Michigan
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Detroit, Michigan, United States, 48202
- Henry Ford Health System
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Owosso, Michigan, United States, 48867
- Memorial Healthcare
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Minnesota
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Minneapolis, Minnesota, United States, 55422
- Minneapolis Clinic of Neurology - Neurology
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North Carolina
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Greensboro, North Carolina, United States, 27405
- Guilford Neurologic Associates
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Texas
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San Antonio, Texas, United States, 78258
- Neurology Center of San Antonio
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Virginia
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Christiansburg, Virginia, United States, 24073
- Blacksburg Neurology, PC
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Richmond, Virginia, United States, 23229
- Neurological Associates
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Virginia Beach, Virginia, United States, 23456
- Sentara Ambulatory Care Center
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Washington
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Kirkland, Washington, United States, 98034
- MS Center of Evergreen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Participants with Multiple Sclerosis and experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to prior treatment with an injectable DMD.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Cladribine Tablets
No intervention will be administered as a part of this study.
Participants who had decided prior to enrollment to transition from any injectable DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI).
Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants.
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No intervention will be administered as a part of this study.
Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Annualized Relapse Rate (ARR) (Prospective Assessment)
Time Frame: Baseline (Month 0) up to 24 Months
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For this study, a relapse will be defined as per routine clinical practice as determined by the investigator.
As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection.
ARR up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.
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Baseline (Month 0) up to 24 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24
Time Frame: Baseline (Month 0), Month 6, 12 and 24
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Baseline (Month 0), Month 6, 12 and 24
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Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24
Time Frame: Baseline (Month 0), Month 6, 12 and 24
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Baseline (Month 0), Month 6, 12 and 24
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Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24
Time Frame: Baseline (Month 0), Month 6, 12 and 24
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Baseline (Month 0), Month 6, 12 and 24
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Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24
Time Frame: Baseline (Month 0), Month 6, 12 and 24
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Baseline (Month 0), Month 6, 12 and 24
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Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24
Time Frame: Baseline (Month 0), Month 6, 12 and 24
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Baseline (Month 0), Month 6, 12 and 24
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Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24
Time Frame: Baseline (Month 0), Month 6, 12 and 24
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Baseline (Month 0), Month 6, 12 and 24
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Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
Time Frame: Baseline (Month 0) and at the end of Months 1, 2, 13 and 14
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Baseline (Month 0) and at the end of Months 1, 2, 13 and 14
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Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS)
Time Frame: At Baseline (Month 0)
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At Baseline (Month 0)
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Percentage of Participants Who Discontinue Cladribine Tablets
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Percentage of Participants With Reason for Discontinuation of Cladribine Tablets
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Elapsed Time to Discontinuation After First Dose of Cladribine Tablets
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Number of Doses Received by Participants as per United States Prescribing Information
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Percentage of Planned Doses Received by Participants as per United States Prescribing Information
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period
Time Frame: Baseline (Month 0) up to 24 Months
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Baseline (Month 0) up to 24 Months
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Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations
Time Frame: Baseline (Month 0) up to 24 months
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A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important.
An ADR is a response to a medicinal product which is noxious and unintended.
An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate.
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Baseline (Month 0) up to 24 months
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Percentage of Participants with Relapse (Prospective Assessment)
Time Frame: Month 12 and 24
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For this study, a relapse will be defined as per routine clinical practice as determined by the investigator.
As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection.
Percentage of participants with relapse up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.
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Month 12 and 24
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Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization
Time Frame: Month 12 and 24
|
For this study, a relapse will be defined as per routine clinical practice as determined by the investigator.
As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection.
Percentage of participants with relapse associated with hospitalization, diagnosis or reason for hospitalization will be reported.
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Month 12 and 24
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Percentage of Participants With Relapse Associated With Glucocorticoid Use
Time Frame: Month 12 and 24
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For this study, a relapse will be defined as per routine clinical practice as determined by the investigator.
As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection.
Percentage of participants with relapse associated with glucocorticoid use up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.
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Month 12 and 24
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Annualized Relapse Rate (ARR) (Retrospective Assessment)
Time Frame: Up to 24 Months prior Baseline (Month 0)
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For this study, a relapse will be defined as per routine clinical practice as determined by the investigator.
As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection.
ARR up to 24 months prior to baseline (retrospectively collected data) will be reported.
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Up to 24 Months prior Baseline (Month 0)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Medical Responsible, EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2019
Primary Completion (Estimated)
February 21, 2026
Study Completion (Estimated)
February 21, 2026
Study Registration Dates
First Submitted
April 29, 2019
First Submitted That Met QC Criteria
April 29, 2019
First Posted (Actual)
May 1, 2019
Study Record Updates
Last Update Posted (Estimated)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 12, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cladribine
Other Study ID Numbers
- MS700568_0078
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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