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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Keep this study
Lead
Biogen
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
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.
Clareo Health | 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
