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

This study has been withdrawn prior to enrollment.
(The study was not feasible to conduct in the US and abroad.)
Sponsor:
Collaborator:
Biogen Idec
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01337427
First received: April 7, 2011
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis
Drug: BIIB017
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography (OCT) in a 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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • Analysis of decrease between baseline scans and 3 month scan (to examine for pseudoatrophy) in this study population. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (12 months) in this study population. [ Time Frame: 3 months and 1 year ] [ Designated as safety issue: No ]
  • Analysis of macular volume decreases from baseline or 3 months to follow up scans at 12 months in this study population. [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 12 months in this study population. [ Time Frame: baseline and 1 year ] [ Designated as safety issue: No ]
  • Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Analysis of proportion of patients with a decrease of >10 percent of baseline value in any RNFL quadrant from baseline to month 24 in the BIIB-17 vs. placebo arms. [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
  • Analysis of decrease between 3 month scans (mean and/or quadrant) and follow up scans (24 months) in this study population. [ Time Frame: 3 months and 2 years ] [ Designated as safety issue: No ]
  • Analysis of macular volume decreases from baseline or 3 months to follow up scans at 24 months in this study population. [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
  • Analysis of retinal nuclear layer decreases from baseline or 3 months to follow up scan at 24 months in this study population. [ Time Frame: baseline and 2 years ] [ Designated as safety issue: No ]
  • Analysis of the above OCT parameters in patients with optic neuritis or history of optic neuritis. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: August 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo for 48 weeks, BIIB017 for 48 weeks
Placebo every 2 weeks for 48 weeks followed by 125 mcg BIIB017 SC every 2 or 4 weeks for 48 weeks.
Drug: BIIB017
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.
Other Names:
  • PEGylated Interferon beta-1a
  • PEG IFN β-1a
Experimental: BIIB017 every 2 weeks for 96 weeks
125 mcg BIIB017 SC every 2 weeks for 96 weeks.
Drug: BIIB017
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.
Other Names:
  • PEGylated Interferon beta-1a
  • PEG IFN β-1a
Experimental: BIIB017 every 4 weeks for 96 weeks
125 mcg BIIB017 SC every 4 weeks for 96 weeks.
Drug: BIIB017
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.
Other Names:
  • PEGylated Interferon beta-1a
  • PEG IFN β-1a

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337427

Sponsors and Collaborators
Johns Hopkins University
Biogen Idec
Investigators
Principal Investigator: Peter Calabresi, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Peter Calabresi, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01337427     History of Changes
Other Study ID Numbers: NA_00028117
Study First Received: April 7, 2011
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
multiple sclerosis
relapsing
MS
injectable
subcutaneous
SC
PEGylated
interferon
PEG
OCT
Optical Coherence Tomography

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon beta 1a
Interferons
Interferon-beta
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014