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WOE of Anti-CD20 Therapies

The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
CompletedRelapsing and progressiveNCT06121349

We could not find results for this trial

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What it found

No result found

We found no results in the registry or in papers.

This trial finished 16 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Proportion of patients who experience wearing-off effect

    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

    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.

    Quality of life (reported by participants)

  • Proportion of patients with worsening ≥ 1 category for PROMIS mental health NRS

    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.

    Quality of life (reported by participants)

  • Proportion of patients with worsening ≥ 1 category for PROMIS fatigue NRS

    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.

    FatigueQuality of life (reported by participants)

  • Proportion of patients with worsening ≥1 category for PROMIS pain NRS

    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

    FatiguePainQuality of life (reported by participants)

  • Median score change for the physical health, mental health, fatigue and pain domains of PROMIS NRS

    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.

    FatiguePainQuality of life (reported by participants)

  • Proportion of patients with worsening ≥ 1 category for Neuro-QoL fatigue scale

    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.

    FatigueQuality of life (reported by participants)

  • Median score change for Neuro-QoL fatigue scale

    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.

    FatigueQuality of life (reported by participants)

  • Proportion of patients with worsening ≥ Minimal Clinically Important Difference (MCID) for Fatigue Severity Scale (FSS)

    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.

    Fatigue

  • Mean score change for Fatigue Severity Scale (FSS)

    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.

    Fatigue

  • Proportion of patients with worsening ≥ significant individual difference (SID) for Neuro-QoL mobility scale

    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.

    Walking and mobilityQuality of life (reported by participants)

  • Proportion of patients with worsening ≥ SID for Neuro-QoL depression scale

    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.

    Mood and sleepQuality of life (reported by participants)

  • Proportion of patients with worsening ≥ SID for Neuro-QoL cognition scale

    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.

    Thinking and memoryQuality of life (reported by participants)

  • Mean score change for Neuro-QoL mobility, depression and cognition domains

    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.

    Thinking and memoryWalking and mobilityMood and sleepQuality of life (reported by participants)

Other measures (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.

    Quality of life (reported by participants)

  • 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.

    Quality of life (reported by participants)

  • 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.

Who could take part

Relapsing and progressive · 21 to 85

Inclusion Criteria: 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 Exclusion Criteria: 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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

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History

    1. Started

      Dec 2023

    2. Main results due

      Jun 2025

    3. Finished

      Jun 2025

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