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NCT Number: NCT04580381

Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort

Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.

One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.

The objective of this study is to assess the efficacy in term of ARR and safety.

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Key information

Conditions

Multiple Sclerosis, Relapsing-Remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, CHU Bobigny-Avicenne, Bobigny, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients receiving at least 11 infusions of natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing

Exclusion criteria

  • Patients for whom the NTZ infusion history and/or MRI and clinical history is not available.
  • Patients with dosing gap defined as >=12 weeks between any two doses.
  • Patients with over dose defined as <3 weeks between any two doses.
  • Pregnancy during the follow-up period

Treatment and study plan

Natalizumab Injection [Tysabri]

Drug

Natalizumab infusion interval according to local practice defining the patient's group

Primary outcomes

  1. Annualized Relapse Ratio

    Time frame: baseline to 12 month follow-up

    relapse rate per patient per year

Secondary outcomes

  1. Disability progression

    Time frame: baseline to 12 month follow-up

    Increase in EDSS score during the follow-up period

  2. NEDA-3 achievement

    Time frame: baseline to 12 month follow-up

    Estimation of the proportion of patients achieving NEDA-3 criteria at the end of the follow-up period

  3. Radiological activity

    Time frame: baseline to 12 month follow-up

    Detection of increase MRI activity defined as new or enlarged T2 lesions and/or new gadolinium enhancing lesions

Other outcomes

  1. Safety outcome

    Time frame: baseline to 12 month follow-up

    Description of PML cases and variations in anti-JCV antibody status when available

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Collaborators

  • Biogen

Registry information

Official study title

Real World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French Cohort

Acronym: RELEVANT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2020
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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