Clinical Disease Activity With Long Term Natalizumab Treatment

Relapsing-Remitting Multiple Sclerosis Clinical Trial

Official title:

MRI and Clinical Disease Activity in Patients Treated Long Term With Natalizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677077
• Other study ID #: BEL-TYS-14-10727
• Status: Completed
• Start date: December 31, 2015
• Est. completion date: August 18, 2016

Study information

• Verified date: December 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: August 18, 2016
• Est. primary completion date: August 18, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis

Intervention

Drug:
• natalizumab
Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic

Locations

Country	Name	City	State
Belgium	Research Site 1	Brussels
Belgium	Research Site 2	Brussels
Belgium	Research Site	Overpelt
Czechia	Research Site	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Belgium,  Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change over time in the number of participants free of new or enlarging FLAIR lesions	Lesions that are =5 mm per scan (slice thickness 3 mm) as assessed by semiautomatic lesion count (by the Icometrix algorithm).	Treatment years 3 and 4
Secondary	Annualized brain volume change rate as assessed by % change in brain parenchymal fraction [BPF]		Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Annualized brain volume change rate as assessed by percent brain volume change [PBVC]		Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Annualized brain volume change rate as assessed by white matter [WM] and gray matter [GM] atrophy)		Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Cumulative number of new =6-month confirmed T1-hypointense lesions		Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Annualized T1-hypointense and FLAIR lesion volume change		Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Cumulative percent change in T1-hypointense and FLAIR lesion volume		Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Cumulative number of =6-month-confirmed T1-hypointense lesions arising from new on- treatment Gadolinium (Gd+)-enhancing lesions	No relapse and no =6-month confirmed Expanded Disability Status Scale (EDSS) progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions	Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Number of total participants and 4-year completers with NEDA as measured by clinical measures	No relapse and no =6-month confirmed EDSS progression and no new or enlarging FLAIR lesions and no new Gd+-enhancing lesions, brain volume change rate as assessed by PBVC	Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Number of total participants and 4-year completers with NEDA as measured by radiological measures	No new or enlarging FLAIR lesions and no new Gd+-enhancing lesions	Post long term treatment with natalizumab (>2 years) through Year 4
Secondary	Number of participants with brain volume loss =0.2% and =0.4%		Post long term treatment with natalizumab (>2 years) through Year 4