N/A
Completed N=100
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
Source: ClinicalTrials.gov NCT03933215 ↗Enrolled (actual)
100
Serious AEs
4.8%
Results posted
Apr 2025
Primary outcomePrimary: Annualized Relapse Rate (ARR) — 0.02 relapses per year
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate (ARR) |
0.02 | — |
| SECONDARY Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 |
32.9; 26.2; 7.1; 24.4; 7.4; -5.6 | — |
| SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Score at Month 6, 12 and 24 |
4.1; -0.4; 1.9; 0.9; 0.3; -2.5 | — |
| SECONDARY Change From Baseline in Modified Fatigue Impact Scale - 5-item Version (MFIS-5) Total Score at Month 6, 12 and 24 |
-2.1; 0.4; 0.0 | — |
| SECONDARY Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24 |
-1.3; -0.1; -1.0 | — |
| SECONDARY 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 |
3.1; -6.3; 0.0 | — |
| SECONDARY 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 |
-11.4; -5.0; 0.0 | — |
| SECONDARY 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 |
-5.1; -6.1; 0.0 | — |
| SECONDARY 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 |
-10.0; -7.7; -5.0 | — |
| SECONDARY Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24 |
-0.2; -0.3; -0.1 | — |
| SECONDARY Number of Participants With Adherence to Cladribine as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) |
28; 38; 38; 21; 18 | — |
| SECONDARY Percentage of Participants Who Experienced Relapse at Months 12 and 24 |
1.6; 1.6 | — |
| SECONDARY Annualized Relapse Rate (ARR) at Month 12 |
0.01955 | — |
| SECONDARY Percentage of Participants Who Experienced Relapse Associated With Hospitalization |
0.0; 0.0 | — |
| SECONDARY Annualized Relapse Rate (ARR) Associated With Hospitalization at Months 12 and 24 |
0.0; 0.0 | — |
| SECONDARY Percentage of Participants Who Experienced Relapse Associated With Glucocorticoid Use |
0.0; 0.0 | — |
| SECONDARY Annualized Relapse Rate (ARR) Associated With Glucocorticoid Use at Months 12 and 24 |
0.0; 0.0 | — |
| SECONDARY Number of Previous Disease-Modifying Drugs (DMD) Received for Multiple Sclerosis (MS) at Baseline |
1.9 | — |
| SECONDARY Number of Participants Who Received At Least One Concomitant Medication |
60 | — |
| SECONDARY Percentage of Participants Who Discontinued Cladribine Tablets |
32.3 | — |
| SECONDARY Elapsed Time to Discontinuation After First Dose of Cladribine Tablets |
13.2 | — |
| SECONDARY Number of Doses Received by Participants as Per United States Prescribing Information |
28.00 | — |
| SECONDARY Percentage of Participants With Treatment Compliance as Per United States Prescribing Information |
82.3 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESIs) |
3; 18; 9 | — |
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
Data sourced from ClinicalTrials.gov (NCT03933215). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.