Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis

Johns Hopkins University

Status and phase: Withdrawn; Phase 3

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: BIIB017

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01337427

NA_00028117

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 3 patient groups, including a placebo group

Placebo for 48 weeks, BIIB017 for 48 weeks

Placebo Comparator group

Description:

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

Treatment:

Drug: BIIB017

BIIB017 every 2 weeks for 96 weeks

Experimental group

Description:

125 mcg BIIB017 SC every 2 weeks for 96 weeks.

Treatment:

Drug: BIIB017

BIIB017 every 4 weeks for 96 weeks

Experimental group

Description:

125 mcg BIIB017 SC every 4 weeks for 96 weeks.

Treatment:

Drug: BIIB017