NCT01337427

Brief Summary

This research sub-study is being completed as a part of the Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis (Protocol #: NA\_00028117). This substudy is being done to understand the efficacy of BIIB017 by measuring the nerve fiber thickness in the eye.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2010

Typical duration for phase_3

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

September 15, 2014

Status Verified

September 1, 2014

Enrollment Period

3 years

First QC Date

April 7, 2011

Last Update Submit

September 12, 2014

Conditions

Relapsing Remitting Multiple Sclerosis

Keywords

multiple sclerosisrelapsingMSinjectablesubcutaneousSCPEGylatedinterferonPEGOCTOptical Coherence Tomography

Outcome Measures

Primary Outcomes (2)

  • To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 12 in the BIIB-17 vs. placebo arms.

    1 year

  • To determine the proportion of patients with RNFL decrease of 5 microns or more from baseline to month 24 in the BIIB-17 vs. placebo arms.

    2 years

Secondary Outcomes (11)

  • Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 12 in the BIIB-17 vs. placebo arms.

    baseline and 1 year

  • Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population.

    baseline and 3 months

  • Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population.

    3 months and 1 year

  • Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population.

    baseline and 1 year

  • Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population.

    baseline and 1 year

  • +6 more secondary outcomes

Study Arms (3)

Placebo for 48 weeks, BIIB017 for 48 weeks

PLACEBO COMPARATOR

Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.

Drug: BIIB017

BIIB017 every 2 weeks for 96 weeks

EXPERIMENTAL

125 mcg BIIB017 SC every 2 weeks for 96 weeks.

Drug: BIIB017

BIIB017 every 4 weeks for 96 weeks

EXPERIMENTAL

125 mcg BIIB017 SC every 4 weeks for 96 weeks.

Drug: BIIB017

Interventions

BIIB017DRUG

BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.

Also known as: PEGylated Interferon beta-1a, PEG IFN β-1a
BIIB017 every 2 weeks for 96 weeksBIIB017 every 4 weeks for 96 weeksPlacebo for 48 weeks, BIIB017 for 48 weeks

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • A participant in the ADVANCE study aged 18 to 55 years old, inclusive, at the time of informed consent

You may not qualify if:

  • As per the ADVANCE main study
  • History of intraocular surgery, retinal disease, glaucoma, or diabetes
  • Refractive errors of more than ±6.0 diopters
  • Inability to tolerate OCT procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisRecurrence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Calabresi, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2011

First Posted

April 18, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 15, 2014

Record last verified: 2014-09