MSFrontier

Full Responders

Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial.
Stopped earlyPhase 4Relapsing MS2016-004819-12

What it found

Stopped early

The trial ended early for another reason (see below).

What was tested

Treatment tested

  • INTERFERONE BETA 1B
  • INTERFERON BETA - 1A
  • GLATIRAMER ACETATO
  • Interferon beta-1a

    Interferon alpha/beta receptor agonist

What it measured

Main measures

  • 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).

    RelapsesMRI lesions

Other measures (1)

  • 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

    Disability progressionRelapsesMRI lesionsFatigueNerve conduction testsMood and sleepQuality of life (reported by participants)

Who could take part

Relapsing MS

Inclusion: - patients with relapsing remitting multiple sclerosis Exclusion: - previous use of immunosuppressive treatments

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To evaluate the risk of reactivation of the disease after first-line DMT discontinuation, in MS patients with prolonged and full-responsive treatment.

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History

    1. Started

      Jan 2022

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