Towards Personalized Dosing of Natalizumab in Multiple Sclerosis

NCT03516526 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2019-07-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Natalizumab

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

Sponsors & Collaborators

  • Prothya Biosolutions

    collaborator INDUSTRY
  • Erasmus Medical Center

    collaborator OTHER
  • St. Antonius Hospital

    collaborator OTHER
  • OLVG

    collaborator NETWORK
  • Rijnstate Hospital

    collaborator OTHER
  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Joep Killestein, Dr. · Amsterdam UMC, location VUmc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2019-06-21
Completion
2019-07-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03516526 on ClinicalTrials.gov