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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03933215
• Other study ID #: MS700568_0078
• Status: Active, not recruiting
• Start date: May 21, 2019
• Est. completion date: February 21, 2026

Study information

• Verified date: May 2024
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: February 21, 2026
• Est. primary completion date: February 21, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Cladribine Tablets
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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
EMD Serono Research & Development Institute, Inc.	Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualized Relapse Rate (ARR) (Prospective Assessment)	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.	Baseline (Month 0) up to 24 Months
Secondary	Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24		Baseline (Month 0), Month 6, 12 and 24
Secondary	Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)		Baseline (Month 0) and at the end of Months 1, 2, 13 and 14
Secondary	Percentage of Participants with Relapse (Prospective Assessment)	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.	Month 12 and 24
Secondary	Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization	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.	Month 12 and 24
Secondary	Percentage of Participants With Relapse Associated With Glucocorticoid Use	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.	Month 12 and 24
Secondary	Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS)		At Baseline (Month 0)
Secondary	Percentage of Participants Who Discontinue Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Percentage of Participants With Reason for Discontinuation of Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Elapsed Time to Discontinuation After First Dose of Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Number of Doses Received by Participants as per United States Prescribing Information		Baseline (Month 0) up to 24 Months
Secondary	Percentage of Planned Doses Received by Participants as per United States Prescribing Information		Baseline (Month 0) up to 24 Months
Secondary	Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets		Baseline (Month 0) up to 24 Months
Secondary	Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period		Baseline (Month 0) up to 24 Months
Secondary	Annualized Relapse Rate (ARR) (Retrospective Assessment)	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.	Up to 24 Months prior Baseline (Month 0)
Secondary	Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations	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.	Baseline (Month 0) up to 24 months

External Links

•   Trial Awareness and Transparency website