Clinical trial NCT03933215: A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
Official title: Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Injectable DMDs for RMS (CLICK-MS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cladribine Tablets
Observational
Mavenclad
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
Collaborators: name: Merck KGaA, Darmstadt, Germany
First posted: 2019-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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 criteria: 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

Primary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Baseline (Month 0) up to 24 Months
Secondary outcomes:
measure: Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Percent Work Time Missed Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Percent Impairment While Working Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Percent Overall Work Impairment Assessed by 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Percent Activity Impairment Assessed by 6-Item Work Productivity Activity Impairment- Multiple Sclerosis (WPAI-MS) Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24
timeFrame: Baseline (Month 0), Month 6, 12 and 24
measure: Number of Participants With Adherence to Cladribine as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)
timeFrame: Baseline (Month 0) and Months 1, 2, 13 and 14
measure: Percentage of Participants Who Experienced Relapse at Months 12 and 24
timeFrame: Months 12 and 24
measure: Annualized Relapse Rate (ARR) at Month 12
timeFrame: At Month 12
measure: Percentage of Participants Who Experienced Relapse Associated With Hospitalization
timeFrame: Months 12 and 24
measure: Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24
timeFrame: Months 12 and 24
measure: Percentage of Participants Who Experienced Relapse Associated With Glucocorticoid Use
timeFrame: Months 12 and 24
measure: Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24
timeFrame: Months 12 and 24
measure: Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline
timeFrame: At Baseline
measure: Number of Participants Who Received At Least One Concomitant Medication
timeFrame: Baseline up to Month 24
measure: Percentage of Participants Who Discontinued Cladribine Tablets
timeFrame: Baseline (Month 0) up to 24 Months
measure: Elapsed Time to Discontinuation After First Dose of Cladribine Tablets
timeFrame: Baseline (Month 0) up to 24 Months
measure: Number of Doses Received by Participants as Per United States Prescribing Information
timeFrame: Baseline (Month 0) up to 24 Months
measure: Percentage of Participants With Treatment Compliance as Per United States Prescribing Information
timeFrame: Baseline (Month 0) up to 24 Months
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs)
timeFrame: Baseline (Month 0) up to 24 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Englewood
country: United States
facility: HCA Research Institute
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurosciences Research
state: Colorado
city: Springfield
country: United States
facility: Prairie Education & Research
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Overland Park
country: United States
facility: College Park Family Care Center
state: Kansas
city: Wellesley
country: United States
facility: The Elliot Lewis Center for Multiple Sclerosis Care, LLC
state: Massachusetts
city: Worcester
country: United States
facility: UMASS - Neurology
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Owosso
country: United States
facility: Memorial Healthcare
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Clinic of Neurology - Neurology
state: Minnesota
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: San Antonio
country: United States
facility: Neurology Center of San Antonio
state: Texas
city: Christiansburg
country: United States
facility: Blacksburg Neurology, PC
state: Virginia
city: Richmond
country: United States
facility: Neurological Associates
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center - Pediatric Neurology
state: Virginia
city: Virginia Beach
country: United States
facility: Sentara Ambulatory Care Center
state: Virginia
city: Kirkland
country: United States
facility: MS Center of Evergreen
state: Washington
Study officials:
affiliation: EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Miravalle AA, Katz J, Robertson D, Hayward B, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJ. CLICK-MS and MASTER-2 Phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis. Neurodegener Dis Manag. 2021 Apr;11(2):99-111. doi: 10.2217/nmt-2020-0059. Epub 2021 Feb 1.