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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)

This study has been withdrawn prior to enrollment.
(Sponsor decision to withdraw study at this time.)
Information provided by:
Biogen Identifier:
First received: October 7, 2008
Last updated: July 29, 2009
Last verified: July 2009
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 Intervention Phase
Relapsing-Remitting Multiple Sclerosis Drug: TYSABRI and AVONEX Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Biogen:

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

Estimated Enrollment: 50
Study Start Date: November 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.
  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.

No Contacts or Locations Provided
  More Information

Responsible Party: Richard Kim, MD, Biogen Idec Identifier: NCT00771043     History of Changes
Other Study ID Numbers: US 010-07-NAT
Study First Received: October 7, 2008
Last Updated: July 29, 2009

Additional relevant MeSH terms:
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
Interferon beta-1a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic processed this record on August 18, 2017