Clinical Disease Activity With Long Term Natalizumab Treatment

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02677077
• Date of registration: 03/12/2015
• Prospective Registration: Yes
• Primary sponsor: Biogen
• Public title: Clinical Disease Activity With Long Term Natalizumab Treatment
• Scientific title: MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab
• Date of first enrolment: December 31, 2015
• Target sample size: 277
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02677077
• Study type: Observational

Countries of recruitment

Belgium, Czech Republic, Czechia

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Relapsing-Remitting Multiple Sclerosis

Intervention(s)

Drug: natalizumab

Primary Outcome(s)

Change over time in the number of participants free of new or enlarging FLAIR lesions [Time Frame: Treatment years 3 and 4]

Secondary Outcome(s)

Number of participants with brain volume loss =0.2% and =0.4% [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Number of total participants and 4-year completers with NEDA as measured by clinical measures [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy) [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Annualized brain volume change rate as assessed by percent brain volume change [PBVC] [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Cumulative number of new =6-month confirmed T1-hypointense lesions [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Cumulative percent change in T1-hypointense and FLAIR lesion volume [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Cumulative number of =6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Number of total participants and 4-year completers with NEDA as measured by radiological measures [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF] [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Annualized T1-hypointense and FLAIR lesion volume change [Time Frame: Post long term treatment with natalizumab (>2 years) through Year 4]

Secondary ID(s)

BEL-TYS-14-10727

Source(s) of Monetary Support

Please refer to primary and secondary sponsors