Multiple SclerosisNCT06121349
WOE of Anti-CD20 Therapies
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- ocrelizumab and ofatumumab
- Type of treatment
- Injection or infusion
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2023to 13 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with MS who are taking ofatumumab or ocrelizumab
Who may be able to join
- OCR sample:
- Self-reported diagnosis of RMS, SPMS or CIS
- ≥21 years old at the time of initial contact
- Under treatment with OCR at the time of initial contact
- Have been on OCR for ≥ 1 year at the time of initial contact (i.e., prevalent users)
- Able to answer the questionnaires in English
Show all 12Show fewer
- OMB sample
- Self-reported diagnosis of RMS, SPMS or CIS
- ≥21 years old at the time of initial contact
- Under treatment with OMB at the time of initial contact
- Have been on OMB for ≥6 months at the time of initial contact (i.e., prevalent users)
- Able to answer the questionnaires in English
Who cannot join
- OCR sample:
- Currently participating in a clinical trial involving MS drugs
- Last Ocrevus infusion was less than 3 months back
- OMB sample:
- Currently participating in a clinical trial involving MS drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
Official title: The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. The current study will explore the wearing-off effect associated with OCR and OMB, using a variety of validated scales assessing MS symptoms (i.e., fatigue, mobility, pain, depression, cognition), as well as some global questions on wearing-off. In addition, impact of worsening of MS symptoms on patients' health-related quality of life (HRQoL) and their work productivity will be assessed using relevant MS-specific validated scales
Read the detailed description
This will be a non-interventional, primary data collection study in patients with MS treated with an established anti-CD20 treatment regimen (OCR or OMB) in the United States. Patients who satisfy the inclusion criteria and consent to participate in the study will be surveyed at four timepoints at the beginning and the end of OCR or OMB treatment cycles according to the following assessment schedule:
- Assessment 1. 0-10 days before 1st dose post-enrollment (index dose)
- Assessment 2: 5-14 days after index dose
- Assessment 3: 0-10 days before 2nd dose post-enrollment (follow-up dose)
- Assessment 4: 5-14 days after follow-up dose dose
- Conditions
- Multiple Sclerosis
- Being tested
- ocrelizumab, ofatumumab
- Keywords
- NIS, Anti-CD20 Therapies, Multiple Sclerosis, OCR, Ocrevus, OMB, KESIMPTA
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocrelizumabDrug
Also called Ocrevus
infusion therapy administered every six months
ofatumumabDrug
Also called KESIMPTA
self-injectable every month
| Study group | Role | What they receive |
|---|---|---|
| OCR | Patients under treatment with Ocrelizumab (OCR) for at least 1 year prior to study start. Receives: Drug: ocrelizumab | |
| OMB | Patients under treatment with ofatumumab (OMB) for at least 6 months prior to study start Receives: Drug: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who experience wearing-off effect
The wearing-off effect questionnaire for this study was modified from a pre-existing tool designed by (Toorop, et al., 2022) such that it is now suitable to assess wearing-off in patients on either infusible or self-injectable disease modifying therapies (DMTs) with different dosing intervals. There is no numeric rating scale (NRS) associated with this endpoint.
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥1 category for PROMIS physical health NRS
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS physical health is measured using the item 3 from the PROMIS Global-10. Scale for PROMIS physical health a is from 1 (worst) - 5 (best).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ 1 category for PROMIS mental health NRS
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS mental health is measured using the item 4 from the PROMIS Global-10. Scale for PROMIS mental health is from 1 (worst) - 5 (best).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ 1 category for PROMIS fatigue NRS
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS fatigue is measured using the item 8r from the PROMIS Global-10. Scale for PROMIS fatigue is from 1 (worst) - 5 (best).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥1 category for PROMIS pain NRS
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS pain is measured using the item 7rc from the PROMIS Global-10. Scale for PROMIS fatigue is from 0 (worst) - 10 (best).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose
Median score change for the physical health, mental health, fatigue and pain domains of PROMIS NRS
PROMIS is a publicly available system of highly reliable, precise measures of patient-reported health status relevant to a variety of chronic conditions including MS.
Mean score change for PROMIS physical health, mental health fatigue and pain NRS to be provided.
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ 1 category for Neuro-QoL fatigue scale
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol fatigue scale is an eight-item short form with a scale ranging from 29.5 (best) - 74.1 (worst).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Median score change for Neuro-QoL fatigue scale
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol fatigue scale is an eight-item short form with a scale ranging from 29.5 (best) - 74.1 (worst).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ Minimal Clinically Important Difference (MCID) for Fatigue Severity Scale (FSS)
The FSS is a publicly available, self-report, nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. Answers are scored on a seven-point scale where 1 corresponds to strongly disagreeing and 7 corresponds to strongly agreeing. Scale for FSS is from 9 (best) - 63 (worst), or 1 (best) - 7 (worst) if the mean of all the scores is reported. The MCID for the mean FSS score is in the 0.5-1.1 range based on (Robinson, et al., 2009)
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Mean score change for Fatigue Severity Scale (FSS)
The FSS is a publicly available, self-report, nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. Answers are scored on a seven-point scale where 1 corresponds to strongly disagreeing and 7 corresponds to strongly agreeing. Scale for FSS is from 9 (best) - 63 (worst), or 1 (best) - 7 (worst) if the mean of all the scores is reported. The MCID for the mean FSS score is in the 0.5-1.1 range based on (Robinson, et al., 2009)
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ significant individual difference (SID) for Neuro-QoL mobility scale
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol mobility scale is an eight-item short form with a scale ranging from 16.5 (worst) - 58.6 (best).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ SID for Neuro-QoL depression scale
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol depression scale is an eight-item short form with a scale ranging from 36.9 (best) - 75.0 (worst).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ SID for Neuro-QoL cognition scale
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol cognition scale is an eight-item short form with a scale ranging from 17.3 (worst) - 64.2 (best).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Mean score change for Neuro-QoL mobility, depression and cognition domains
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations.
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Secondary outcomes (3)
Mean score change for both domains (physical impact and psychological impact) of Multiple Sclerosis Impact Scale (MSIS-29)
The MSIS-29 questionnaire evaluates the influence of MS-related symptoms on physical and psychological functioning in daily life and contains 29 questions, of which 20 address the physical impact component and nine assess the psychological impact. Physical and psychological scale scores are generated by summing individual items and then transformed to a 0 (best) -100 (worst) scale.
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ MCID for the MSIS-29
The MSIS-29 questionnaire evaluates the The MSIS-29 questionnaire evaluates the influence of MS-related symptoms on physical and psychological functioning in daily life and contains 29 questions, of which 20 address the physical impact component and nine assess the psychological impact. Physical and psychological scale scores are generated by summing individual items and then transformed to a 0 (best) -100 (worst) scale. The MCID for the physical impact score (6.8) and psychological impact score (7.4) are based on the work from (Greene, et al., 2023).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Mean score change for each of the 4 domains of the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS)
The Work Productivity and Activity Impairment: MS (WPAI:MS) questionnaire is a well validated instrument measuring the effect of MS on work productivity and regular activities during the past seven days. The questions are computed according to specific calculation rules and have four scores: (1) percentage work time missed due to health (absenteeism); (2) percentage impairment at work due to health (presenteeism); (3) percentage overall work productivity loss due to MS; and (4) percentage daily activity impairment outside of work due to MS. Scale for each of the 4 domains is 0% (best) - 100% (worst).
Measured: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start4 Dec 2023
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121349
- Sponsor's protocol ID
- COMB157AUS22
- Status last verified
- Jul 2025
- First submitted
- 31 Oct 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06121349
- Acronym / sponsor ID
- COMB157AUS22
- Conditions
- Multiple Sclerosis
- Keywords
- NIS, Anti-CD20 Therapies, Multiple Sclerosis, OCR, Ocrevus, OMB, KESIMPTA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2023 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. The current study will explore the wearing-off effect associated with OCR and OMB, using a variety of validated scales assessing MS symptoms (i.e., fatigue, mobility, pain, depression, cognition), as well as some global questions on wearing-off. In addition, impact of worsening of MS symptoms on patients' health-related quality of life (HRQoL) and their work productivity will be assessed using relevant MS-specific validated scales
Detailed description
This will be a non-interventional, primary data collection study in patients with MS treated with an established anti-CD20 treatment regimen (OCR or OMB) in the United States. Patients who satisfy the inclusion criteria and consent to participate in the study will be surveyed at four timepoints at the beginning and the end of OCR or OMB treatment cycles according to the following assessment schedule:
- Assessment 1. 0-10 days before 1st dose post-enrollment (index dose)
- Assessment 2: 5-14 days after index dose
- Assessment 3: 0-10 days before 2nd dose post-enrollment (follow-up dose)
- Assessment 4: 5-14 days after follow-up dose dose
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCR | – | Drug: ocrelizumabPatients under treatment with Ocrelizumab (OCR) for at least 1 year prior to study start. |
| OMB | – | Drug: ofatumumabPatients under treatment with ofatumumab (OMB) for at least 6 months prior to study start |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with MS who are taking ofatumumab or ocrelizumab
Key inclusion criteria (12 listed)
- Self-reported diagnosis of RMS, SPMS or CIS
- ≥21 years old at the time of initial contact
- Under treatment with OCR at the time of initial contact
- Have been on OCR for ≥ 1 year at the time of initial contact (i.e., prevalent users)
- Able to answer the questionnaires in English
Key exclusion criteria (5 listed)
- Currently participating in a clinical trial involving MS drugs
- Last Ocrevus infusion was less than 3 months back
- Currently participating in a clinical trial involving MS drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ocrelizumabAlso: Ocrevusinfusion therapy administered every six months | Drug | OCR |
| ofatumumabAlso: KESIMPTAself-injectable every month | Drug | OMB |
Primary outcome
Proportion of patients who experience wearing-off effect
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
The wearing-off effect questionnaire for this study was modified from a pre-existing tool designed by (Toorop, et al., 2022) such that it is now suitable to assess wearing-off in patients on either infusible or self-injectable disease modifying therapies (DMTs) with different dosing intervals. There is no numeric rating scale (NRS) associated with this endpoint.
Proportion of patients with worsening ≥1 category for PROMIS physical health NRS
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS physical health is measured using the item 3 from the PROMIS Global-10. Scale for PROMIS physical health a is from 1 (worst) - 5 (best).
Proportion of patients with worsening ≥ 1 category for PROMIS mental health NRS
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS mental health is measured using the item 4 from the PROMIS Global-10. Scale for PROMIS mental health is from 1 (worst) - 5 (best).
Proportion of patients with worsening ≥ 1 category for PROMIS fatigue NRS
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS fatigue is measured using the item 8r from the PROMIS Global-10. Scale for PROMIS fatigue is from 1 (worst) - 5 (best).
Proportion of patients with worsening ≥1 category for PROMIS pain NRS
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose
The PROMIS Global-10 is a publicly available global health assessment tool that allows measurements of symptoms, functioning, and healthcare-related quality of life (HRQoL) for a wide variety of chronic diseases and conditions. PROMIS pain is measured using the item 7rc from the PROMIS Global-10. Scale for PROMIS fatigue is from 0 (worst) - 10 (best).
Median score change for the physical health, mental health, fatigue and pain domains of PROMIS NRS
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
PROMIS is a publicly available system of highly reliable, precise measures of patient-reported health status relevant to a variety of chronic conditions including MS. Mean score change for PROMIS physical health, mental health fatigue and pain NRS to be provided.
Proportion of patients with worsening ≥ 1 category for Neuro-QoL fatigue scale
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol fatigue scale is an eight-item short form with a scale ranging from 29.5 (best) - 74.1 (worst).
Median score change for Neuro-QoL fatigue scale
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol fatigue scale is an eight-item short form with a scale ranging from 29.5 (best) - 74.1 (worst).
Proportion of patients with worsening ≥ Minimal Clinically Important Difference (MCID) for Fatigue Severity Scale (FSS)
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
The FSS is a publicly available, self-report, nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. Answers are scored on a seven-point scale where 1 corresponds to strongly disagreeing and 7 corresponds to strongly agreeing. Scale for FSS is from 9 (best) - 63 (worst), or 1 (best) - 7 (worst) if the mean of all the scores is reported. The MCID for the mean FSS score is in the 0.5-1.1 range based on (Robinson, et al., 2009)
Mean score change for Fatigue Severity Scale (FSS)
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
The FSS is a publicly available, self-report, nine-item instrument designed to assess fatigue as a symptom of a variety of different chronic conditions and disorders. Answers are scored on a seven-point scale where 1 corresponds to strongly disagreeing and 7 corresponds to strongly agreeing. Scale for FSS is from 9 (best) - 63 (worst), or 1 (best) - 7 (worst) if the mean of all the scores is reported. The MCID for the mean FSS score is in the 0.5-1.1 range based on (Robinson, et al., 2009)
Proportion of patients with worsening ≥ significant individual difference (SID) for Neuro-QoL mobility scale
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol mobility scale is an eight-item short form with a scale ranging from 16.5 (worst) - 58.6 (best).
Proportion of patients with worsening ≥ SID for Neuro-QoL depression scale
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol depression scale is an eight-item short form with a scale ranging from 36.9 (best) - 75.0 (worst).
Proportion of patients with worsening ≥ SID for Neuro-QoL cognition scale
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations. The Neuro-Qol cognition scale is an eight-item short form with a scale ranging from 17.3 (worst) - 64.2 (best).
Mean score change for Neuro-QoL mobility, depression and cognition domains
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Neuro-QoL is a publicly available set of self-report measures that assesses the HRQoL of adults and children with neurological disorders. Neuro-QoL is comprised of item banks and scales that evaluate symptoms, concerns, and issues that are relevant across disorders along with instruments that assess areas most relevant for specific patient populations.
3 secondary outcomes
Mean score change for both domains (physical impact and psychological impact) of Multiple Sclerosis Impact Scale (MSIS-29)
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Proportion of patients with worsening ≥ MCID for the MSIS-29
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Mean score change for each of the 4 domains of the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS)
Time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Individual participant dataSharing planned: No
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Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who experience wearing-off effect (time frame: Up to 10 days before index dose (first dose) post enrollment, from 5 to 14 days after index dose, up to 10 days before second dose post enrollment, from 5 to 14 days after second dose.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.