Clinical Disease Activity With Long Term Natalizumab Treatment

• Status: Completed
• Trial end date: 2016-08-18
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to retrospectively investigate the proportion of participants free of new or enlarging fluid-attenuated inversion recovery (FLAIR) lesions over time in approximately 300 Relapsing-Remitting Multiple Sclerosis (RRMS) participants with regular MRI follow-up, who have received natalizumab ≥24 month from two different observational cohorts: 1) approximately 230 participants from the Czech Republic; and 2) approximately 70 participants from Belgium. The secondary objectives of this study are as follows: Brain volume change by various measures; Changes in the number and volume of magnetic resonance imaging (MRI) lesions; No evidence of disease activity (NEDA) with and without brain volume change.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biogen
• Treatments: Natalizumab

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.