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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 (PRTOECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00771043
Recruitment Status : Withdrawn (Sponsor decision to withdraw study at this time.)
First Posted : October 10, 2008
Last Update Posted : July 30, 2009
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Relapsing-Remitting Multiple Sclerosis Drug: TYSABRI and AVONEX Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
Study Start Date : November 2008
Estimated Primary Completion Date : August 2009
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups. [ Time Frame: Between week 4 and weeks 36 ]

Secondary Outcome Measures :
  1. Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups. [ Time Frame: Between week 4 and weeks 36 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Responsible Party: Richard Kim, MD, Biogen Idec Identifier: NCT00771043    
Other Study ID Numbers: US 010-07-NAT
First Posted: October 10, 2008    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs