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Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab

NCT02881567 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2019-09-27

Study results available
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Summary

The primary objective of the study is to evaluate the effects of treatment with daclizumab on the proportion of participants relapse-free at 6 months in Relapsing-Remitting Multiple Sclerosis (RRMS) participants, who switched from treatment with natalizumab to daclizumab due to safety concerns. The secondary objectives of this study in this study population are to evaluate the effects of daclizumab on the following: 1) Multiple Sclerosis (MS) relapse activity including the annualized relapse rate (ARR) and the proportion of participants experiencing relapses requiring hospitalization and/or steroid treatment; 2) MS-related outcomes measured using magnetic resonance imaging (MRI); 3) Safety and tolerability in participants previously treated with natalizumab.

Conditions

  • Relapsing-Remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

Daclizumab

High yield formulation

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-18
Primary Completion
2018-09-12
Completion
2018-09-12
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Germany
  • Italy
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

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 NCT02881567 on ClinicalTrials.gov