Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-03

Study Completion Date

2019-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A prospective clinical trial with the aim of maintaining drug efficacy of natalizumab while extending dose intervals guided by drug concentrations in patients with relapsing remitting multiple sclerosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple Sclerosis

NCT04225312

Relapsing Remitting Multiple Sclerosis

UNKNOWN PHASE4

B Cell Tailored Ocrelizumab Versus Standard Ocrelizumab in Relapsing Remitting Multiple Sclerosis

NCT05296161

Multiple Sclerosis, Relapsing-Remitting

RECRUITING PHASE4

Clinical Disease Activity With Long Term Natalizumab Treatment

NCT02677077

Relapsing-Remitting Multiple Sclerosis

COMPLETED

Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

NCT01405820

Relapsing-Remitting Multiple Sclerosis

COMPLETED PHASE2

Neurocognitive Changes in Patients With Remitting Relapsing Multiple Sclerosis Treated With Natalizumab

NCT01250678

Multiple Sclerosis Cognitive Impairment

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Our main objective is to prove that extending dose intervals guided by natalizumab serum concentrations, will not result in radiological or clinical disease activity in completely stable RRMS patients treated with natalizumab. Adult patients with RRMS with no evident disease activity during the last 12 months of natalizumab infusions with a minimum treatment of 12 months wil be included. Before subsequent natalizumab infusions, serum concentrations will be evaluated. If the concentration exceeds 15μg/ml the dose interval will be extended with a week to a maximum of eight weeks. Patients will get regular brain MRI scans and clinical follow-up.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

All patients in this study

Patients treated with natalizumab with a minimum of 1 year, without signs of disease activity (relapses, new T2 lesions on MRI) for a minimum of 1 year.

Group Type OTHER

Natalizumab

Intervention Type DRUG

Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Natalizumab

Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Relapsing-remitting multiple sclerosis (RRMS) according to the McDonald criteria, revised by Polman 2010
* Natalizumab treatment for 12 months or longer at inclusion.
* An expanded disability status scale (EDSS) score of 0.0-6.0 at baseline.
* Natalizumab level of ≥15 μg/ml
* Written informed consent.

Exclusion Criteria

* Any MS disease activity (radiologically or clinically) during the last 12 months of natalizumab treatment.
* Unable to undergo frequent MRI.
* The use of other immunomodulatory medication other than natalizumab.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No