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NCT04486716 · ClinicalTrials.gov registry record · Phase 3

A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
111
Enrollment target

NCT04486716: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.

NCT04486716 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 111 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04486716, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
111 participants
Enrollment target

Study Summary

A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

Primary Outcome

Magnetic Resonance Imaging (MRI) was used to measure presence of new or reduction in number of gadolinium enhancing T1 lesions. Each MRI scan was previewed by a local neuroradiologist. The quality of each scan performed was assessed by a central MRI reading center and evaluated for quality, completeness and adherence to the protocol. A nonresponder imputation (NRI) for missing data approach was applied. NRI assumes that a participant was a treatment failure, i.e. non-responder, if they did not

Interventions

  • DRUG Ofatumumab

Trial Details

FieldValue
Enrollment Target 111 participants
Start Date 2020-10-19
Est. Completion 2024-10-21
Phase Phase 3
Novartis Pharmaceuticals

1,375 total trials

What the finished NCT04486716 record still lists

NCT04486716 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).

The record links to 0 conditions, and to 1 intervention - of which Ofatumumab is the first listed.

NCT04486716 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04486716 about?

NCT04486716 is a clinical study titled "A Single Arm Study Evaluating the Efficacy, Safety and Tolerability of Ofatumumab in Patients With Relapsing Multiple Sclerosis". A single arm study evaluating the continued efficacy, safety and tolerability of ofatumumab in patients with relapsing multiple sclerosis who are transitioning from aCD20 mAb therapy

What is the current status of trial NCT04486716?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 111 participants. The study started on 2020-10-19. Estimated completion is 2024-10-21.

What interventions are being tested in trial NCT04486716?

The interventions under investigation include: Ofatumumab (DRUG).

Who is sponsoring clinical trial NCT04486716?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04486716's enrollment target sits among peer trials

111 1655th of 2000 higher than 344 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04486716, the US trial registry maintained by the National Library of Medicine. NCT04486716 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.