Trial · NCT03933202
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
NCT03933202, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2026-01-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2). Trials, record NCT03933202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03933202
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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 Oral or Infusion DMDs for RMS (MASTER-2)
- NCT number
- NCT03933202
- Status
- Completed
- Enrollment
- 291 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- Multiple Sclerosis
- Interventions
- Cladribine Tablets
- First posted
- 2019-05-01
- Last updated
- 2026-01-02
- Results first posted
- 2026-01-02
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Annualized Relapse Rate (ARR) | From first dose of cladribine tablets up to 24 months | A relapse was 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 was calculated as the total number of reported relapses in the 24 months after treatment divided by the days on study corresponding to relapse information and multiplied by 365.25. |
| 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) Domain Score at Month 6, 12 and 24 | Baseline (Month 0), Month 6, 12 and 24 | The SF-36 Health Survey is a validated, self-administered questionnaire designed to assess general health status across eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It includes one item evaluating perceived change in health over the past year and generates two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-derived using factor analytic methods. Each domain and summary score is scaled from 0 to 100, with higher scores indicating better health status. |
| 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 MFIS-5 is a shortened version of the Fatigue Impact Scale consisting of 5 items that assess the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale: 0 (Never), 1 (Rarely), 2 (Sometimes), 3 (Often), and 4 (Almost always). The total score ranges from 0 to 20, with higher scores indicating a greater impact of fatigue. Items include: reduced alertness, limitations in activities away from home, difficulty sustaining physical effort, reduced ability to complete tasks requiring physical effort, and trouble concentrating. |
| 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-item Beck Depression Inventory-Fast Screen (BDI-FS) is a self-report tool used to assess the severity of depressive symptoms. It includes seven items: Sadness, Pessimism, Past Failure, Loss of Pleasure, Self-Dislike, Self-Criticalness, and Suicidal Thoughts. Each item is rated on a 4-point scale from 0 to 3, with higher scores indicating greater symptom severity. The total score ranges from 0 to 21 and is calculated by summing the highest-rated response for each item. |
| Secondary | Change From Baseline in Percentage of 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-item 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 work time missed (absenteeism) was reported. |
| Secondary | Change From Baseline in Percentage of 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-item 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 Percentage of 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-item 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 Percentage of 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-item 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 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 | The PDDS is a patient-reported scale to assess the disability status in participants with MS, and it focuses mainly on how participants walk. Scores on the PDDS range from 0 (normal) to 8 (bedridden): 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 represents higher level of disability. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in 36-Item Short Form Health Survey (SF-36) Domain Score at Month 6, 12 and 24 | Baseline (Month 0), Month 6, 12 and 24 | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Percentage of 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | percentage of work time missed | MEAN |
| SECONDARY | Change From Baseline in Percentage of 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | percentage of impairment while working | MEAN |
| SECONDARY | Change From Baseline in Percentage of 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | percentage of overall work impairment | MEAN |
| SECONDARY | Change From Baseline in Percentage of 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific 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 FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | units on a scale | MEAN |
| SECONDARY | Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) | Month 1, 2, 13 and 14 | The FAS included all participants enrolled in the study who received at least 1 dose of cladribine tablets. Overall number of participants analyzed refers to those evaluable for the outcome measure, while number analyzed refers to those evaluable at specific timepoints. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group157
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Score at Month 6, 12 and 24 | Cladribine Tablets: Switch From Oral | Global Satisfaction: Month 6 | 18.5 | Standard Deviation 30.42 | 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 Tablets: Switch From Infusion | Global Satisfaction: Month 6 | 22.2 | Standard Deviation 15.14 | 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 Tablets: Switch From Oral | Global Satisfaction: Month 12 | 11.1 | Standard Deviation 25.95 | 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 Tablets: Switch From Infusion | Global Satisfaction: Month 12 | 19.0 | Standard Deviation 21.82 | 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 Tablets: Switch From Oral | Global Satisfaction: Month 24 | 16.1 | Standard Deviation 24.31 | 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 Tablets: Switch From Infusion | Global Satisfaction: Month 24 | -28.6 | 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 Tablets: Switch From Oral | Effectiveness: Month 6 | 10.5 | Standard Deviation 29.13 | 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 Tablets: Switch From Infusion | Effectiveness: Month 6 | 22.2 | Standard Deviation 21.08 | 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 Tablets: Switch From Oral | Effectiveness: Month 12 | 3.9 | Standard Deviation 24.09 | 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 Tablets: Switch From Infusion | Effectiveness: Month 12 | 24.1 | Standard Deviation 30.60 | units on a scale |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cladribine Tablets: Switch From Oral | 163 | |
| Overall Study | STARTED | Cladribine Tablets: Switch From Infusion | 120 | |
| Overall Study | Participants Who Received at Least 1 Dose of Cladribine Tablets | Cladribine Tablets: Switch From Oral | 103 | |
| Overall Study | Participants Who Received at Least 1 Dose of Cladribine Tablets | Cladribine Tablets: Switch From Infusion | 85 | |
| Overall Study | Switch From Ocrelizumab | Cladribine Tablets: Switch From Oral | 0 | |
| Overall Study | Switch From Ocrelizumab | Cladribine Tablets: Switch From Infusion | 53 | |
| Overall Study | COMPLETED | Cladribine Tablets: Switch From Oral | 116 | |
| Overall Study | COMPLETED | Cladribine Tablets: Switch From Infusion | 92 | |
| Overall Study | NOT COMPLETED | Cladribine Tablets: Switch From Oral | 47 | |
| Overall Study | NOT COMPLETED | Cladribine Tablets: Switch From Infusion | 28 |
Source ClinicalTrials.gov
Adverse events418
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 | Lymphadenopathy | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Oral | 1 | 103 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Infusion | 0 | 85 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Oral | 20 | 103 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Infusion | 4 | 85 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Oral | 1 | 103 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Infusion | 0 | 85 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Oral | 0 | 103 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cladribine Tablets: Switch From Infusion | 1 | 85 | |
| other | Left ventricular dysfunction | Cardiac disorders | Cladribine Tablets: Switch From Oral | 1 | 103 | |
| other | Left ventricular dysfunction | Cardiac disorders | Cladribine Tablets: Switch From Infusion | 0 | 85 |
1 to 10 of 418Source ClinicalTrials.gov
See all 418 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cladribine Tablets: Switch From Oral | 2 | 103 |
| Total, all-cause mortality | Cladribine Tablets: Switch From Infusion | 0 | 85 |
| Total, other adverse events | Cladribine Tablets: Switch From Oral | 65 | 103 |
| Total, other adverse events | Cladribine Tablets: Switch From Infusion | 51 | 85 |
| Total, serious adverse events | Cladribine Tablets: Switch From Oral | 10 | 103 |
| Total, serious adverse events | Cladribine Tablets: Switch From Infusion | 14 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33517769 | DERIVED |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cladribine Tablets: Switch From Oral vs Cladribine Tablets: Switch From Infusion: Number of Participants With At Least One Concomitant Medication | Trial comparisons |
| Cladribine Tablets: Switch From Oral vs Cladribine Tablets: Switch From Infusion: deaths from any cause | Trial comparisons |
| Cladribine Tablets: Switch From Oral vs Cladribine Tablets: Switch From Infusion: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03933202
GET https://conductscience.org/api/trials/v1/NCT03933202/registered?page=2