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PRTOECT: 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

Sponsor
Biogen (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00771043
Collaborator
(none)
50
Enrollment
2
Arms
19
Duration (Months)

Study Details

Study Description

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
  • Drug: TYSABRI and AVONEX
 Phase 4

Study Design

Study Type:
Interventional
Anticipated 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 :
Nov 1, 2008
Anticipated Primary Completion Date :
Aug 1, 2009
Anticipated Study Completion Date :
Jun 1, 2010

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
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

Locations

No locations specified.

Sponsors and Collaborators

  • Biogen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00771043
Other Study ID Numbers:
  • US 010-07-NAT
First Posted:
Oct 10, 2008
Last Update Posted:
Jul 30, 2009
Last Verified:
Jul 1, 2009
Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Natalizumab

Study Results

No Results Posted as of Jul 30, 2009