NCT02657915

Brief Summary

The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
11 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 18, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 10, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2017

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

September 23, 2019

Completed
Last Updated

September 23, 2019

Status Verified

August 1, 2019

Enrollment Period

11 months

First QC Date

December 23, 2015

Results QC Date

May 7, 2019

Last Update Submit

August 16, 2019

Conditions

Acute Optic Neuritis

Keywords

FF-VEPmfVEPHuman anti-LINGO-1BIIB033AON

Outcome Measures

Primary Outcomes (1)

  • FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161)

    A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.

    Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)

Secondary Outcomes (7)

  • Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)

    RENEW Study (NCT01721161) to Day 1 (NCT02657915)

  • Time to Diagnosis of CDMS

    RENEW Study (NCT01721161) to Day 1 (NCT02657915)

  • Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)

    Day 1 (NCT02657915)

  • Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)

    Day 1 (NCT02657915)

  • Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment

    Day 1 (NCT02657915)

  • +2 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

This was a follow-up study, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo.

Drug: Placebo

BIIB033 100mg/Kg

EXPERIMENTAL

This was a follow-up study, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033.

Drug: BIIB033 100mg/Kg

Interventions

PlaceboDRUG

Administered as specified in the treatment arm.

Also known as: Sterile normal saline (0.9% sodium chloride for IV administration)
Placebo
BIIB033 100mg/KgDRUG

Administered as specified in the treatment arm.

BIIB033 100mg/Kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01721161).

You may not qualify if:

  • Not previously enrolled in Study NCT01721161
  • Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of Gd but will otherwise be allowed to participate in the study, including magnetic resonance imaging (MRI) assessments not requiring the use of Gd.
  • Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Research Site

Sydney, New South Wales, Australia

Location

Research Site

Parkville, Victoria, Australia

Location

Research Site

Bruges, Belgium

Location

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Olomouc, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Glostrup Municipality, Denmark

Location

Research Site

Bamberg, Germany

Location

Research Site

Berlin, Germany

Location

Research Site

Dresden, Germany

Location

Research Site

Düsseldorf, Germany

Location

Research Site

Tübingen, Germany

Location

Research Site

Budapest, Hungary

Location

Research Site

Milan, Italy

Location

Research Site

Barcelona, Spain

Location

Research Site

Córdoba, Spain

Location

Research Site

Murcia, Spain

Location

Research Site

Seville, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Solna, Sweden

Location

Research Site

Birmingham, United Kingdom

Location

Research Site

Glasgow, United Kingdom

Location

Research Site

London, United Kingdom

Location

MeSH Terms

Interventions

Sodium ChlorideOrganization and Administrationopicinumab

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHealth Services Administration

Results Point of Contact

Title
Biogen Study Medical Director
Organization
Biogen
clinicaltrials@biogen.com
866-633-4636

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This was a follow-up study with no investigational product; however, the allocation method in RENEW Study (NCT01721161) was randomised-controlled and to maintain the blind from RENEW, the treatment disclosure for RENEW was not shared with study sites or participants until the end of this study.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2015

First Posted

January 18, 2016

Study Start

March 10, 2016

Primary Completion

January 23, 2017

Study Completion

January 23, 2017

Last Updated

September 23, 2019

Results First Posted

September 23, 2019

Record last verified: 2019-08

Locations

CZ(2)CA(1)ES(5)GB(3)DK(1)DE(5)BE(1)HU(1)AU(2)IT(1)SE(1)