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

Phase 4

Withdrawn

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: TYSABRI and AVONEX

• Registration Number: NCT00771043
• Lead Sponsor: Biogen

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-10-07
• Study First Submitted QC: 2008-10-09
• Study First Posted: 2008-10-10
• Study Start: 2008-11-01
• Primary Completion: 2009-08-01
• Study Completion: 2010-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TYSABRI	TYSABRI and AVONEX	-
AVONEX	TYSABRI and AVONEX	-

Primary Outcome Measures

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

Secondary Outcome Measures

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