A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
- Registration Number
- NCT03933215
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cladribine Cladribine -
- Primary Outcome Measures
Name Time Method Annualized Relapse Rate (ARR) Baseline (Month 0) up to 24 Months The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).
- Secondary Outcome Measures
Name Time Method Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) Baseline (Month 0) up to 24 months 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.
Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline At Baseline Number of previous DMD received by participants with MS were reported.
Number of Participants Who Received At Least One Concomitant Medication Baseline up to Month 24 Number of participants who received at least one concomitant medication were reported.
Percentage of Participants Who Discontinued Cladribine Tablets Baseline (Month 0) up to 24 Months Percentage of participants who discontinued cladribine tablets were reported.
Elapsed Time to Discontinuation After First Dose of Cladribine Tablets Baseline (Month 0) up to 24 Months Elapsed time to discontinuation after first dose of cladribine tablets was reported.
Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 Baseline (Month 0), Month 6, 12 and 24 The TSQM-14 was a participant-rated scale used to assess subjective satisfaction with medication. The TSQM has 14 questions that assesses participants' global satisfaction level with their treatment in 4 domains: side effects (There are 5 questions in the side effects domain, however one of them is a Yes/No question and there are 4 sub-components, hence a maximum score of 20), effectiveness (3 questions), global satisfaction (3 questions), and convenience (3 questions). All questions are scored from 1 (least satisfied) to 5 or 7 (most satisfied). The total score is summed for each domain to obtain: side effects (1-20), effectiveness (1-21), global satisfaction (1-17), and convenience (1-21), using transformed scores between 0 and 100. Lower total scores in each domain indicate dissatisfaction with the study medication and higher total scores indicate satisfaction.
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Month 6, 12 and 24 Baseline (Month 0), Month 6, 12 and 24 SF-36 was a multipurpose, participant completed, short-form health survey with 36 questions that consists of an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary measures. Physical component summary (PCS) is mostly contributed by physical function (PF), role physical (RP), bodily pain (BP), and general health (GH). Mental component summary (MCS) is mostly contributed by mental health (MH), role emotional (RE), social function (SF), and vitality (VT). Each component on the SF-36 item health survey is scored from 0 (best) to 100 (worst). Total score ranges from 0-100 for each component summary (i.e., PCS and MCS), where higher scores are associated with less disability and better quality of life.
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 MFIS-5 is a modified form of the Fatigue Impact Scale that consists of 5 questions that assess the impact of fatigue on physical, cognitive, and psychosocial functioning, with 5 response levels ranging from 0 to 4, where 0 = (Never), 1 = (Rarely), 2 = (Sometimes), 3 = (Often), 4 = (Almost always). Total scores range from 0 to 20, with higher scores representing a greater impact of fatigue.
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 The 7 items BDI-FS is a self-report inventory for measuring the severity of depression on a 7-item scale. The BDI-Fast Screen is scored by summing all of the highest ratings for each of the 7 items. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 21. Higher scores indicate greater symptom severity.
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 Baseline (Month 0), Month 6, 12 and 24 The WPAI-MS questionnaire is a 6-items validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percent work time missed (absenteeism) was reported.
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 Baseline (Month 0), Month 6, 12 and 24 The WPAI-MS questionnaire is a 6-items validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percentage of impairment while working (presentisms) was reported.
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 Baseline (Month 0), Month 6, 12 and 24 The WPAI-MS questionnaire is a 6-items validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in total percentage of work impairment (absenteeism and presentisms) were reported.
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 Baseline (Month 0), Month 6, 12 and 24 The WPAI-MS questionnaire is a 6-items validated instrument to measure impairments in work and activities. The WPAI-MS included 6 questions: 1 (if currently employed); 2 (hours missed due to disease); 3 (hours missed other reasons); 4 (hours actually worked); 5 (degree disease affected productivity while working); 6 (degree disease affected regular activities). WPAI-MS generated four component scores: percentage of work time missed (absenteeism); percentage of impairment while working (presentisms); percentage of overall work impairment (absenteeism and presentisms combined); and percentage of activity impairment. Scores for WPAI range from 0% to 100%, where 0 % indicates no impairment and 100% is total loss of work productivity/activity. Change from baseline in percent activity impairment was reported.
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 PDDS scale developed to assess the disability in Multiple Sclerosis (MS) participants and in assessing disease progression that focuses mainly on how participants walk. PDDS scale ranges from 0 to 8, where 0 = normal; 1 = mild disability; 2 = moderate disability; 3 = gait disability; 4 = early cane; 5 = late cane; 6 = bilateral support; 7 = wheelchair/scooter and 8 = bedridden. A higher score represented higher level of disability.
Number of Participants With Adherence to Cladribine as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) Baseline (Month 0) and Months 1, 2, 13 and 14 7 Treatment adherence questions, based on MS-TAQ, were developed to determine level of adherence as well as identify barriers to adherence for MS participants taking DMDs. 1.What treatment week of cladribine (Clad.) tablets (tab.) did you most recently complete? 2.How many Clad. tab. were you supposed to take during this treatment week? 3.Did you miss/forget to take any Clad. tab. during this treatment week? 4. How many Clad. tab. did you miss/ forget to take? 5.How important were following factors in missing/forgetting to take a dose? (scale from 0-3, where, 0=Not important at all and 3=Extremely important). 6.Overall, how hard/easy do you feel it is to take Clad. tab. as recommended by your physician during your treatment week? (scale from 1- 5, where 1=Extremely easy and 5=Extremely hard). 7.How satisfied are you with how things have been with your Clad. tab. treatment during your treatment week? (scale from 1-5, where 1=Not satisfied at all and 5=Completely satisfied).
Percentage of Participants Who Experienced Relapse at Months 12 and 24 Months 12 and 24 The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days). Percentage of participants who experienced relapse at Months 12 and 24 were reported.
Annualized Relapse Rate (ARR) at Month 12 At Month 12 The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).
Percentage of Participants Who Experienced Relapse Associated With Hospitalization Months 12 and 24 The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days). Percentage of participants who experienced relapse associated with hospitalization at Months 12 and 24 were reported.
Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 Months 12 and 24 The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days). ARR associated with hospitalization at Months 12 and 24 were reported.
Percentage of Participants Who Experienced Relapse Associated With Glucocorticoid Use Months 12 and 24 The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days).Percentage of participants who experienced relapse associated with glucocorticoid use at Months 12 and 24 were reported.
Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 Months 12 and 24 The qualifying relapse is the occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis (MS) (for more than \[\>\] 24 hours, no fever, infection, injury, adverse events (AEs), and preceded by a stable or improving neurological state for more than or equal to \[\>=\] 30 days). ARR associated with glucocorticoid use at Months 12 and 24 were reported.
Number of Doses Received by Participants as Per United States Prescribing Information Baseline (Month 0) up to 24 Months Number of doses received by participants as per United States prescribing information were reported.
Percentage of Participants With Treatment Compliance as Per United States Prescribing Information Baseline (Month 0) up to 24 Months Treatment compliance was defined as total actual number of cladribine tablets / total planned number of cladribine tablets.
Trial Locations
- Locations (18)
VCU Medical Center - Pediatric Neurology
🇺🇸Richmond, Virginia, United States
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
Sentara Ambulatory Care Center
🇺🇸Virginia Beach, Virginia, United States
MS Center of Evergreen
🇺🇸Kirkland, Washington, United States