Back to resultsA 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)
Primary Purpose
Relapsing-Remitting Multiple Sclerosis
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
TYSABRI and AVONEX
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
No Intervention
Arm Label
TYSABRI
AVONEX
Arm Description
Outcomes
Primary Outcome Measures
Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups.
Secondary Outcome Measures
Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00771043
Brief Title
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
Acronym
PRTOECT
Official Title
Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision to withdraw study at this time.
Study Start Date
November 2008 (undefined)
Primary Completion Date
August 2009 (Anticipated)
Study Completion Date
June 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TYSABRI
Arm Type
No Intervention
Arm Title
AVONEX
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
TYSABRI and AVONEX
Intervention Description
TYSABRI and AVONEX treatment per package insert.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups.
Time Frame
Between week 4 and weeks 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
12. IPD Sharing Statement
Learn more about this trial
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
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