Clinical Disease Activity With Long Term Natalizumab Treatment

Launched by BIOGEN · Feb 4, 2016

Keywords

ClinConnect Summary

Natalizumab will not be provided to participants by Biogen as a part of this study. Participants will remain on natalizumab therapy as prescribed by their physician.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • Diagnosis of RRMS.
• • Continuous treatment with natalizumab of ≥24 months. In case of a treatment interruption from natalizumab ≥60 days after a total treatment period of ≥24 months, only the treatment prior to the interruption will be analyzed. Any data after this treatment interruption (even if the patient restarts natalizumab) will not be analyzed/collected.
• • ≥1 MRI scan of sufficient quality for reliable measurement.
• • Baseline MRI scan ≤6 month prior to natalizumab treatment acquired.
• • ≥1 MRI scan of sufficient quality for reliable measurement taken while on natalizumab treatment for ≥6 months.
• • EDSS ≤ 6.5.
• Key Exclusion Criteria:
• • Anti-natalizumab antibody detection.
• • Prior treatment with alemtuzumab.
• • Prior treatment with mitoxantrone within 12 months of the first infusion of natalizumab.
• • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.