A Follow-Up Study to Look at Long-Term Responses in Subjects who previously took part in Study 215ON201

Phase 1

• Conditions: Acute Optic Neuritis; MedDRA version: 18.0 Level: PT Classification code 10030942 Term: Optic neuritis System Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-003618-26-GB
• Lead Sponsor: Biogen Idec Research Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-05
• Study Completion: 2017-01-23
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

1. Must have participated in Study 215ON201 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 215ON201).
2. Ability of the subject to understand the purpose and risks 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Not previously enrolled in Study 215ON201.
2. Inability to comply with study requirements.
3. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrolment.
4. Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of gadolinium (Gd) but will otherwise be allowed to participate in the study, including MRI assessments not requiring the use of Gd.
5. Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study 215ON201 2 years (+ 4 months) after the last study visit.;Secondary Objective: The secondary objective is to assess clinical progression and severity of CNS demyelinating disease in subjects who were enrolled in Study 215ON201 2 years (+ 4 months) after the last study visit.;Primary end point(s): The primary endpoint is the change in FF-VEP latency of the affected eye as compared to the baseline of the fellow eye at 2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201.;Timepoint(s) of evaluation of this end point: 2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - Evaluate incidence of CDMS and time to diagnosis of CDMS.<br> - Evaluate severity of CNS demyelinating disease with Expanded Disability Status Scale (EDSS) and multiple sclerosis functional composite (MSFC).<br> - Evaluate change in disease activity from baseline with brain MRI with and without gadolinium (Gd). MRI analysis will include the number of Gd-enhanced lesions and the volume of T2 lesions.<br> ;Timepoint(s) of evaluation of this end point: 2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201.