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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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing-Remitting Multiple Sclerosis

Intervention: TYSABRI and AVONEX (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: Biogen


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).

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.

Secondary outcome: Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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


- 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.

Locations and Contacts

Additional Information

Starting date: November 2008
Last updated: July 29, 2009

Page last updated: August 23, 2015

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