Trial · NCT03933215
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
NCT03933215, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2025-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS). Trials, record NCT03933215. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03933215
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
- NCT number
- NCT03933215
- Status
- Completed
- Enrollment
- 100 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Multiple Sclerosis
- Interventions
- Cladribine
- First posted
- 2019-05-01
- Last updated
- 2025-04-29
- Results first posted
- 2025-04-29
- Limitations and caveats
There are methods to adjustment for missing-not-at-random, but these methods are varied and inconsistent, especially with high missingness. Knowing we have low counts for many outcomes, we reported the data that we have, accepting that there will be patients with missing data who are missing assessments due to sickness or other non-random reasons.
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Annualized Relapse Rate (ARR) | Baseline (Month 0) up to 24 Months | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall number of participants analyzed signifies those participants who were evaluable for this outcome measure. | relapses per year | MEAN |
| SECONDARY | 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 Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | units on a scale | MEAN |
| SECONDARY | 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 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | units on a scale | MEAN |
| 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 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | units on a scale | MEAN |
| 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 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | units on a scale | MEAN |
| 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 | Baseline (Month 0), Month 6, 12 and 24 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | percentage of work time missed | MEAN |
| 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 | Baseline (Month 0), Month 6, 12 and 24 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | percentage of impairment while working | MEAN |
| 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 | Baseline (Month 0), Month 6, 12 and 24 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | percentage of overall work impairment | MEAN |
| 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 | Baseline (Month 0), Month 6, 12 and 24 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those participants who were evaluable at each specified timepoints. | percentage of activity impairment | MEAN |
| 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 | The Full Analysis Set (FAS) included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Here, overall Number of participants analyzed signifies those participants who were evaluable for this outcome measure and number analyzed signifies those who were evaluable for specified categories. | units on a scale | MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group65
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Annualized Relapse Rate (ARR) | Cladribine | 0.02 | 95% Confidence Interval 0.000 to 0.059 | relapses per year | |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Global Satisfaction: change at Month 6 | 32.9 | Standard Deviation 29.01 | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Global Satisfaction: change at Month 12 | 26.2 | Standard Deviation 21.43 | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Global Satisfaction: change at Month 24 | 7.1 | Standard Deviation NA | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Effectiveness: change at Month 6 | 24.4 | Standard Deviation 23.45 | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Effectiveness: change at Month 12 | 7.4 | Standard Deviation 35.13 | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Effectiveness: change at Month 24 | -5.6 | Standard Deviation NA | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Side Effects: change at Month 6 | -8.8 | Standard Deviation 41.37 | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Side Effects: change at Month 12 | -18.1 | Standard Deviation 24.69 | units on a scale |
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine | Side Effects: change at Month 24 | 0.0 | Standard Deviation NA | units on a scale |
1 to 10 of 65Source ClinicalTrials.gov
See all 65 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cladribine | 100 | |
| Overall Study | Treated | Cladribine | 62 | |
| Overall Study | COMPLETED | Cladribine | 34 | |
| Overall Study | NOT COMPLETED | Cladribine | 66 |
Source ClinicalTrials.gov
Adverse events69
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cladribine | 1 | 62 | |
| other | Lymphadenitis | Blood and lymphatic system disorders | Cladribine | 1 | 62 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cladribine | 9 | 62 | |
| other | Eustachian tube dysfunction | Ear and labyrinth disorders | Cladribine | 1 | 62 | |
| other | Vertigo positional | Ear and labyrinth disorders | Cladribine | 1 | 62 | |
| other | Thyroid disorder | Endocrine disorders | Cladribine | 1 | 62 | |
| other | Abdominal discomfort | Gastrointestinal disorders | Cladribine | 2 | 62 | |
| other | Diarrhoea | Gastrointestinal disorders | Cladribine | 1 | 62 | |
| other | Gastrointestinal pain | Gastrointestinal disorders | Cladribine | 1 | 62 | |
| other | Haemorrhoids | Gastrointestinal disorders | Cladribine | 1 | 62 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cladribine | 0 | 62 |
| Total, other adverse events | Cladribine | 34 | 62 |
| Total, serious adverse events | Cladribine | 3 | 62 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33517769 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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