CompletedRelapsing MSNCT02247310

What it found

No result found

We found no results in the registry or in papers.

This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

  • Adherence to therapy at the final visit.

    Up to 24 weeks

    Quality of life (reported by participants)

Other measures (9)

  • Satisfaction with and evaluation of the BETACONNECT auto-injector

    At baseline,4 weeks,12 weeks and 24 weeks

    Quality of life (reported by participants)
  • Injection site pain and prophylactic analgesic use

    At baseline,4 weeks,12 weeks and 24 weeks

    PainSafety
  • Health related quality of life

    At baseline,12 weeks and 24 weeks

    Quality of life (reported by participants)
  • Anxiety

    At baseline,12 weeks and 24 weeks

    Mood and sleep
  • Depression

    At baseline,12 weeks and 24 weeks

    Mood and sleep
  • Fatigue

    At baseline,12 weeks and 24 weeks

    Thinking and memoryFatigue
  • Cognition

    At baseline,12 weeks and 24 weeks

    Thinking and memory
  • Local skin reactions

    At baseline,4 weeks,12 weeks and 24 weeks

  • Injection-related specifics

    At 4 weeks,12 weeks and 24 weeks

Who could take part

Relapsing MS

Inclusion Criteria: * Patients with the diagnosis of relapsing remitting multiple sclerosis or a clinically isolated syndrome. * Patients must be on treatment with Betaferon or the decision to treat a patient with Betaferon has been made by the attending physician. * Patient and attending physicians must have agreed on the usage of the BETACONNECT auto-injector device. * Written informed consent must be obtained. Exclusion Criteria: * Patients receiving any other disease modifying drug. * Contraindications of Betaferon described in the Summary of Product Characteristics.

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

About this trial

In the sponsor's words

Considering the significance of an early and consequent Multiple Sclerosis (MS) treatment as well as the challenge to achieve high adherence to treatment, evaluating the benefits of any new measure to improve adherence is important. The data storage capabilities of the BETACONNECT device, including the automated recording of injections, will facilitate the collection of reliable data on patient's injection behavior and adherence, which should be unaffected by recall bias or reporting bias. To better understand the utilities of the new BETACONNECT device and characterize its contribution to adherence, we plan to prospectively follow-up MS patients using this device for 24 weeks. The study will take place in a real-life setting in Neurology centers across Europe.

Papers

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    Related trials

    History

      1. Started

        Oct 2014

      2. Main results due

        Jul 2016

      3. Finished

        Nov 2016

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