Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients

Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004819-12-IT

Enrollment

300

Registered

2022-01-20

Start date

2018-01-10

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing-Remitting multiple sclerosis (RR-MS), MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders

Interventions

Trade Name: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML Product Name: Interferone Beta-1B Product Code: [032166011] Pharmaceutical Form: Powder and solvent for solution for injection INN or

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - patients with relapsing remitting multiple sclerosis - males and females patients - free from attacks and MRI active lesions in the last 4 years - patients who require the discontinuation of DMT - age between 18-55 years - EDSS =65 years) yes F.1.3.1 Number of subjects for this age range 70

Exclusion criteria

Exclusion criteria: - previous use of immunosuppressive treatments - previous use of any experimental disease modifying treatments - clinically relevant systemic diseases - pregnancy For IFNß-treated group: - history of hypersensitivity to natural or recombinant interferon, human albumin, or any other component of the IFNß formulation - history of depression and/or suicidal ideation - active liver disease For GA-treated group: - history of hypersensitivity to GA or mannitol.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the risk of reactivation of the disease after first-line DMT discontinuation, in MS patients with prolonged and full-responsive treatment.;Secondary Objective: The secondary objective is to identify the predictive factors of disease reactivation after DMTs discontinuation: - demographic and clinical variables (age, sex, disease and treatment duration, index of progression, EDSS, relapse annualized rate 1 and 2 years before starting DMT, interval between first and second attack, relapse rate in first 2 years of disease – where applicable-); - laboratory findings (presence or absence of Oligoclonal Bands in the CSF, Vitamin D level at randomization); - brain MRI variables (T2 hyperintense, T1 hypointense and Gd-enhancing lesion volumes at baseline, at disease onset, at treatment onset); - multimodal evoked potential abnormalities at randomisation (motor, sensory, acoustic, visual).;Primary end point(s): Proportion of patients free from disease activity at two years, defined as the combination of freeedom from attacks and < 2 cumulative brain MRI active lesions (combination of gadolinium enhancing lesions and new T2 lesions).;Timepoint(s) of evaluation of this end point: 2 years	—

Measure

Time frame

Main Objective: To evaluate the risk of reactivation of the disease after first-line DMT discontinuation, in MS patients with prolonged and full-responsive treatment.;Secondary Objective: The secondary objective is to identify the predictive factors of disease reactivation after DMTs discontinuation: - demographic and clinical variables (age, sex, disease and treatment duration, index of progression, EDSS, relapse annualized rate 1 and 2 years before starting DMT, interval between first and second attack, relapse rate in first 2 years of disease – where applicable-); - laboratory findings (presence or absence of Oligoclonal Bands in the CSF, Vitamin D level at randomization); - brain MRI variables (T2 hyperintense, T1 hypointense and Gd-enhancing lesion volumes at baseline, at disease onset, at treatment onset); - multimodal evoked potential abnormalities at randomisation (motor, sensory, acoustic, visual).;Primary end point(s): Proportion of patients free from disease activity at two years, defined as the combination of freeedom from attacks and < 2 cumulative brain MRI active lesions (combination of gadolinium enhancing lesions and new T2 lesions).;Timepoint(s) of evaluation of this end point: 2 years

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Secondary

Measure	Time frame
Secondary end point(s): Proportion of relapse-free patients; Proportion of NEDA patients (absence of relapses, 12 week Confirmed Disability Progression, T1 Gd-enhancing lesion or new/enlarging T2 lesion); Time to disease reactivation (clinical or MRI); Time to first relapse; Proportion of patients free of MRI active lesions; Proportion of patients with Sustained Disability Progression; Comparison of frequency and degree of neurophysiological abnormalities during the study; Comparison of fatigue, depression, QoL, anxiety and depression scales, between the two groups;Timepoint(s) of evaluation of this end point: 2 years; 12 weeks; 2 years; 2 years; 2 years; 2 years; 2 years; 2 years	—

Measure

Time frame

Secondary end point(s): Proportion of relapse-free patients; Proportion of NEDA patients (absence of relapses, 12 week Confirmed Disability Progression, T1 Gd-enhancing lesion or new/enlarging T2 lesion); Time to disease reactivation (clinical or MRI); Time to first relapse; Proportion of patients free of MRI active lesions; Proportion of patients with Sustained Disability Progression; Comparison of frequency and degree of neurophysiological abnormalities during the study; Comparison of fatigue, depression, QoL, anxiety and depression scales, between the two groups;Timepoint(s) of evaluation of this end point: 2 years; 12 weeks; 2 years; 2 years; 2 years; 2 years; 2 years; 2 years

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Countries

Italy

Contacts

Public ContactDirezione Scientifica

Phidealive S.r.l.

m.salomone@phidealive.com0236580933

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026