Condition category
Nervous System Diseases
Date applied
26/04/2017
Date assigned
22/05/2017
Last edited
22/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Multiple sclerosis (MS) is a chronic (long-term) inflammatory disease of the central nervous system (brain and/or spinal cord). More than 2 million people are affected worldwide. Most MS patients (90%) suffer from relapsing remitting MS, where they have episodes of new or worsening symptoms (e.g., vision problems, numbness, muscle weakness), known as relapses, which then slowly improve. Relapses are often reversible to begin with, but over time there is a slow deterioration of neurological functions. The aim of this study is to collect further data on the effectiveness and safety of the drug daclizumab, which is used to treat relapsing MS.

Who can participate?
Patients aged 18 and over with relapsing remitting MS who are starting treatment with daclizumab

What does the study involve?
Participants are followed for up to 60 months after starting treatment or until death, withdrawal, or the participants is considered lost to follow up, whichever occurs first. Follow up is planned regardless of whether treatment with daclizumab is stopped, unless informed consent is withdrawn or a participant joins another study. Assessments are completed and data is collected at the start of the study, 3 and 6 months after starting daclizumab treatment, and every 6 months thereafter for up to 60 months. The proportion of patients who still are on treatment with daclizumab, their reasons for stopping treatment, treatment adherence, relapses, progression of disability and side effects are all measured at each visit.

What are the possible benefits and risks of participating?
No benefits or risks are expected.

Where is the study run from?
160 sites, led by Carl Gustav Carus Management GmbH, university hospital, clinic for neurosciences (Germany)

When is the study starting and how long is it expected to run for?
December 2016 to June 2023

Who is funding the study?
Biogen GmbH (Germany)

Who is the main contact?
Dr Nadia Spitznagel
nadia.spitznagel@biogen.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nadia Spitznagel

ORCID ID

Contact details

Carl-Zeiss-Ring 6
85737 Ismaning
85737
Germany
+49 (0)89 99617 337
nadia.spitznagel@biogen.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EUR-ZIN-16-11024

Study information

Scientific title

A Phase 4, 5-year, multicenter, prospective, observational, single-cohort study to document utilization, effectiveness and safety of daclizumab in subjects with relapsing forms of MS in clinical practice in Germany

Acronym

ZEUS

Study hypothesis

To evaluate persistence on treatment with daclizumab in RMS patients starting therapy in clinical practice.
Primary endpoint: proportion of patients who are on treatment with daclizumab at Month 24 after treatment initiation.

Ethics approval

Ethics committee at the Technical University Dresden (Technische Universität Dresden), 15/12/2016, ref: EK 474112016

Study design

Multicenter prospective observational single-cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Relapsing remitting multiple sclerosis (RMS)

Intervention

Non-interventional, observational study; diagnosis and treatment are done only in compliance with clinical routine

This is a multicenter, prospective, observational, single-cohort study to document utilization, effectiveness and safety of daclizumab monotherapy in patients with RMS who have been newly prescribed treatment with daclizumab in a routine clinical practice setting and according to locally approved prescribing information.

Approximately 1,000 subjects will be enrolled over an 18-month period from about 160 sites in Germany and will be followed for up to 60 months since initiation of treatment or until death, withdrawal, or the subject is considered lost to follow up, whichever occurs first. Follow up is planned regardless whether treatment with daclizumab is discontinued, unless informed consent is withdrawn or a subject is enrolled in another investigational trial.

The Prescribing Physicians will participate in the study as Investigators.

Subjects will be enrolled after the decision to treat with daclizumab has been made, or as soon as possible after the start of daclizumab treatment as long as complete demographic and baseline information as requested per study protocol is available; however, before their fourth dose of daclizumab at the latest.

Assessments will be completed and data collected at baseline, 3 and 6 months after initiation of daclizumab treatment and approximately every 6 months thereafter for up to completion of 60 months.

Intervention type

Drug

Phase

Not Applicable

Drug names

Daclizumab

Primary outcome measures

Proportion of patients who are on treatment with daclizumab at Month 24 after treatment initiation (current therapy is documented at each visit: baseline, 3 months, 6 months, and every 6 months until month 60)

Secondary outcome measures

1. Proportion of patients who are on treatment with daclizumab at Month 60 after treatment initiation (current therapy is documented at each visit)
2. Reasons for stopping a therapy with daclizumab (if applicable); therapy is documented at each visit
3. Therapy adherence, self reported by patients in a diary and documented by participating physician at each visit
4. Relapse rates per year and percentage of patients without relapse; time until first relapse; relapses are documented at each visit
5. Progression of disability (24 weeks after start of therapy), measured by EDSS score
6. AEs and SAEs, documented at each visit
7. Complete blood count, lymphocyte sub-populations, measured at each visit
8. Patient reported outcomes:
8.1. Patients’ views regarding consequences of MS, measured using Multiple Sclerosis Impact Scale (MSIS-29)
8.2. Quality of life, measured using EuroQoL-5D (EQ-5D)
8.3. Treatment satisfaction, measured using Treatment Satisfaction Questionnaire for Medication (TSQM 1.4)
8.4. Cognitive functions, measured using the Symbol Digit Modalities Test (SDMT)
Visits take place at baseline, 3 months, 6 months, and every 6 months until month 60

Overall trial start date

15/12/2016

Overall trial end date

15/06/2023

Reason abandoned

Eligibility

Participant inclusion criteria

1. Ability to understand the purpose of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations
2. Start of daclizumab therapy in accordance with local prescribing information; the decision for the daclizumab therapy must be made before study inclusion; patients can be enrolled until before administration of fourth daclizumab dose - provided baseline data are available
3. Aged at least 18 years at time of enrolment; no upper age limit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

1. Missing ability or willingness to give informed consent after information about the study
2. Missing eligibility for participation from physician's point of view
3. Contraindication to treatment with daclizumab or diseases which are contraindicated according to the local prescribing information
4. Concomitant therapy with another disease-modifying MS-therapy
5. Current or planned participation in a clinical interventional study

Recruitment start date

15/12/2016

Recruitment end date

15/06/2018

Locations

Countries of recruitment

Germany

Trial participating centre

Carl Gustav Carus Management GmbH, university hospital, clinic for neurosciences
Fetscherstraße 74
Dresden
01307
Germany

Sponsor information

Organisation

Biogen GmbH

Sponsor details

Carl-Zeiss-Ring 6
Ismaning
85737
Germany
+49 (0)89 99617 0
germany.information@biogen.com

Sponsor type

Industry

Website

https://www.biogen.de

Funders

Funder type

Industry

Funder name

Biogen GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Presentation of study design at DGN and ECTRIMS 2017
2. Presentation of first baseline data at ECTRIMS 2017
3. Planned publications in established journals about one year after trial end date

IPD sharing plan
The data will be held by the sponsor (Biogen Germany) and published in articles, abstracts and publications. Data for individuals will not be available due to data protection reasons.

Intention to publish date

15/06/2024

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes