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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This study has been withdrawn prior to enrollment.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.)
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00771043
First received: October 7, 2008
Last updated: July 29, 2009
Last verified: July 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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
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.

  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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Richard Kim, MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00771043     History of Changes
Other Study ID Numbers: US 010-07-NAT
Study First Received: October 7, 2008
Last Updated: July 29, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Interferon-beta
 Interferons
Interferon beta 1a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on May 21, 2013