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NCT06121349 · ClinicalTrials.gov registry record
WOE of Anti-CD20 Therapies
A clinical trial, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- 157
- Enrollment target
NCT06121349: Completed study, sponsored by Novartis Pharmaceuticals.
NCT06121349 is a clinical trial that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 157 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06121349 has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- 157 participants
- Enrollment target
Study 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
Primary Outcome
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.
Interventions
- DRUG ofatumumab
- DRUG ocrelizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2023-12-04 |
| Est. Completion | 2025-06-13 |
What the finished NCT06121349 record still lists
NCT06121349 is an observational study that tracks outcomes without assigning an intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which ofatumumab is the first listed.
NCT06121349 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06121349 about?
NCT06121349 is a clinical study titled "WOE of Anti-CD20 Therapies". 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 explor...
What is the current status of trial NCT06121349?
This trial is currently completed. The enrollment target is 157 participants. The study started on 2023-12-04. Estimated completion is 2025-06-13.
What interventions are being tested in trial NCT06121349?
The interventions under investigation include: ofatumumab (DRUG), ocrelizumab (DRUG).
Who is sponsoring clinical trial NCT06121349?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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