drugset / Trial / NCT00771043

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

NCT00771043

Phase 4 Withdrawn Biogen
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2008-11-01
Primary completion
2009-08-01
Completion
2010-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon beta-1a Protein / enzyme biologic
Subject natalizumab Monoclonal antibody