Clinical trial NCT06121349: WOE of Anti-CD20 Therapies
Official title: The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: NIS
Anti-CD20 Therapies
Multiple Sclerosis
OCR
Ocrevus
OMB
KESIMPTA
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with MS who are taking ofatumumab or ocrelizumab

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

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

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of patients who experience wearing-off effect
timeFrame: 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.
measure: Proportion of patients with worsening ≥1 category for PROMIS physical health NRS
timeFrame: 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.
measure: Proportion of patients with worsening ≥ 1 category for PROMIS mental health NRS
timeFrame: 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.
measure: Proportion of patients with worsening ≥ 1 category for PROMIS fatigue NRS
timeFrame: 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.
measure: Proportion of patients with worsening ≥1 category for PROMIS pain NRS
timeFrame: 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
measure: Median score change for the physical health, mental health, fatigue and pain domains of PROMIS NRS
timeFrame: 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.
measure: Proportion of patients with worsening ≥ 1 category for Neuro-QoL fatigue scale
timeFrame: 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.
measure: Median score change for Neuro-QoL fatigue scale
timeFrame: 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.
measure: Proportion of patients with worsening ≥ Minimal Clinically Important Difference (MCID) for Fatigue Severity Scale (FSS)
timeFrame: 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.
measure: Mean score change for Fatigue Severity Scale (FSS)
timeFrame: 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.
measure: Proportion of patients with worsening ≥ significant individual difference (SID) for Neuro-QoL mobility scale
timeFrame: 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.
measure: Proportion of patients with worsening ≥ SID for Neuro-QoL depression scale
timeFrame: 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.
measure: Proportion of patients with worsening ≥ SID for Neuro-QoL cognition scale
timeFrame: 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.
measure: Mean score change for Neuro-QoL mobility, depression and cognition domains
timeFrame: 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:
measure: Mean score change for both domains (physical impact and psychological impact) of Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 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.
measure: Proportion of patients with worsening ≥ MCID for the MSIS-29
timeFrame: 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.
measure: Mean score change for each of the 4 domains of the Work Productivity and Activity Impairment Questionnaire for MS (WPAI:MS)
timeFrame: 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.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Investigational site
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: