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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This study has been withdrawn prior to recruitment.
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov Identifier: NCT00771043
  Purpose

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 IV

MedlinePlus related topics: Multiple Sclerosis
Drug Information available for: Natalizumab Interferons Interferon beta Interferon-beta Interferon beta 1a
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment
Official Title: Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Further study details as provided by Biogen Idec:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
TYSABRI: No Intervention Drug: TYSABRI and AVONEX
TYSABRI and AVONEX treatment per package insert.
AVONEX: No Intervention Drug: TYSABRI and AVONEX
TYSABRI and AVONEX treatment per package insert.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00771043

Locations
United States, California
Research Site
Los Angeles, California, United States, 90033
United States, Connecticut
Research Site
New Haven, Connecticut, United States, O6510
United States, Maryland
Research Site
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Research Site
Boston, Massachusetts, United States, 02215
United States, Michigan
Research Site
East Lansing, Michigan, United States, 48824
United States, Mississippi
Research Site
Jackson, Mississippi, United States, 39216
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19104
Research Site
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Research Site
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Biogen Idec
  More Information

Responsible Party: Biogen Idec ( Richard Kim, MD )
Study ID Numbers: US 010-07-NAT
Study First Received: October 7, 2008
Last Updated: January 5, 2009
ClinicalTrials.gov Identifier: NCT00771043  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon beta 1a
Interferon-beta
Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:
Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Adjuvants, Immunologic
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009