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PLATINUM

Multicenter Interventional Phase IV Study for the Assessment of the Effects on Patient's Satisfaction of Plegridy (Pre-filled Pen) in Subjects With Relapsing-remitting Multiple Sclerosis Unsatisfied With Other Injectable Subcutaneous Interferons (PLATINUM)
CompletedPhase 4Relapsing MSNCT025870652015-002201-11

What it found

Missed its main goal

The main measure did not show a significant benefit.

MeasureEstimate95% CIp
Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12Spearman's correlation coefficient -0.85-3.72–2.020.56

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

Results by group

Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12

Baseline, Week 12

GroupValueIntervalNumber analysed
Peg-interferon Beta-1a 125 μg38.5 score on a scale13.9 (Standard Deviation)193
Peg-interferon Beta-1a 125 μg38.5 score on a scale23.3 (Standard Deviation)193

Peg-interferon Beta-1a 125 μg

38.5

Peg-interferon Beta-1a 125 μg

38.5

p = 0.56; Spearman's correlation coefficient -0.85 (95% CI -3.72–2.02)

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Peg-interferon Beta-1a 125 μg1930 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12

    Baseline, Week 12

    Quality of life (reported by participants)Safety

  • Changes from baseline in the score of convenience satisfaction domain of TSQM-9 at 12 weeks

    Quality of life (reported by participants)

Other measures (11)

  • Change From Baseline in the Score of All Domains of TSQM-9 at Week 24

    Baseline, Week 24

    Quality of life (reported by participants)Safety

  • Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24

    Baseline, Weeks 12 and 24

    Quality of life (reported by participants)

  • Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24

    Baseline, Weeks 12 and 24

    Fatigue

  • Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24

    Baseline, Weeks 12 and 24

    Quality of life (reported by participants)Immune responseSafety

  • Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24

    Baseline, Weeks 12 and 24

    Bladder, bowel and sexual functionQuality of life (reported by participants)

  • Change From Baseline in Annualized Relapse Rate (ARR) at Week 24

    Baseline, Week 24

    Relapses

  • Percent Change in Relapse-Free Participants at Week 24

    Baseline, Week 24

    Relapses

  • Number of Participants With Adverse Events (AE)

    Baseline up to Week 24

    Safety

  • Number of Participants With AE Stratified by Severity

    Baseline up to Week 24

  • Number of Participants With Clinical Abnormal Laboratory Values

    Baseline up to Week 24

Who could take part

Relapsing MS · 18 to 65

Key Inclusion Criteria: * Subjects diagnosed with Relapsing Remitting MS according to 2010 McDonald criteria. * Subjects with EDSS score between 0.0 and 5.0 at baseline. Key Exclusion Criteria: * Pregnancy or breast-feeding. * Have any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

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

About this trial

In the sponsor's words

The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants' satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants' adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on participants' injection-system satisfaction; Evaluate the relationship between participants' satisfaction and adherence; Evaluate the relationship between participants' satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate the treatment safety and tolerability.

Papers

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    History

      1. Started

        Feb 2016

      2. Main results due

        Oct 2017

      3. Finished

        Dec 2017

      4. Results posted

        Jan 2020

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