WOE of Anti-CD20 Therapies

NCT06121349 | Completed

• 1 other identifier: COMB157AUS22
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Multiple Sclerosis

Keywords

NIS; Anti-CD20 Therapies; Multiple Sclerosis; OCR; Ocrevus; OMB; KESIMPTA

Outcome Measures

Primary Outcomes (14)

• 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.

  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).

  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).

  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).

  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).

  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.

  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).

  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).

  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)

  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)

  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).

  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).

  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).

  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.

  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)

  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

  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)

  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.

Study Arms (2)

OCR

Patients under treatment with Ocrelizumab (OCR) for at least 1 year prior to study start.

Drug: ocrelizumab

OMB

Patients under treatment with ofatumumab (OMB) for at least 6 months prior to study start

Drug: ofatumumab

Interventions

ocrelizumab DRUG

infusion therapy administered every six months

Also known as: Ocrevus

OCR

ofatumumab DRUG

self-injectable every month

Also known as: KESIMPTA

OMB

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with MS who are taking ofatumumab or ocrelizumab

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab; ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: December 4, 2023
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)