Status:
WITHDRAWN
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
Lead Sponsor:
Biogen
Conditions:
Relapsing-remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00771043
Start Date
November 1 2008
End Date
June 1 2010
Last Update
June 3 2024
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