A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a (PRTOECT)

Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).

Study Overview

• Status: Withdrawn
• Conditions: Relapsing-Remitting Multiple Sclerosis
• Intervention / Treatment: Drug: TYSABRI and AVONEX

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of RRMS.
• Patients with unilateral AON consistent with Multiple Sclerosis (MS).
• Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset.
• Age 18-55 years.
• Expanded Disability Status Scale (EDSS) 0 to 5.0.
• Understand and sign informed consent.

Exclusion Criteria:

• History or presence of progressive multifocal leukoencephalopathy (PML).
• Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS).
• Immune-compromised in the judgment of the Investigator.
• History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study.
• Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc).
• Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago.
• Previous treatment with > 1 Disease Modifying Therapy (DMT).
• Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy.
• Previous treatment with TYSABRI®
• Women who are not postmenopausal, surgically sterile, or willing to practice contraception.
• Women pregnant, breast feeding, or planning to become pregnant.
• Involved with other study protocol simultaneously without prior approval.
• Determined not suitable for study participation by Investigator and/or Sponsor.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: TYSABRI	Drug: TYSABRI and AVONEX; TYSABRI and AVONEX treatment per package insert.
No Intervention: AVONEX	Drug: TYSABRI and AVONEX; TYSABRI and AVONEX treatment per package insert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.	Between week 4 and weeks 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.	Between week 4 and weeks 36

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Anticipated): August 1, 2009
• Study Completion (Anticipated): June 1, 2010

Study Registration Dates

• First Submitted: October 7, 2008
• First Submitted That Met QC Criteria: October 9, 2008
• First Posted (Estimate): October 10, 2008

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 29, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Natalizumab
• Other Study ID Numbers: US 010-07-NAT