Phase 4
N=193
Plegridy Satisfaction Study in Participants
Relapsing-Remitting Multiple Sclerosis (RRMS)
Bottom Line
View on ClinicalTrials.gov: NCT02587065 ↗Enrolled (actual)
193
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 — 38.5; 38.5 score on a scale — p=0.56
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- peginterferon beta-1a (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Convenience Satisfaction Score of Treatment Satisfaction Questionnaire to Medication (TSQM-9) at Week 12 |
38.5; 38.5 | 0.56 |
| SECONDARY Change From Baseline in the Score of All Domains of TSQM-9 at Week 24 |
38.5; 41.9; 47.0; 21.2; 41.4; 27.9 | — |
| SECONDARY Change From Baseline in Number of Participants With Adherence to Study Treatment at Weeks 12 and 24 |
113; 65; 53 | — |
| SECONDARY Change From Baseline in Fatigue Status Scale (FSS) Score at Weeks 12 and 24 |
40.1; -4.6; -3.8 | — |
| SECONDARY Change From Baseline in Adapted Sclerosis Treatment Concerns Questionnaire (MSTCQ) Score at Weeks 12 and 24 |
71.9; -16.8; -19.4 | — |
| SECONDARY Change From Baseline in Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Week 12 and 24 |
67.8; 4.6; 5.0 | — |
| SECONDARY Change From Baseline in Annualized Relapse Rate (ARR) at Week 24 |
0.15; -0.03 | — |
| SECONDARY Percent Change in Relapse-Free Participants at Week 24 |
-7.94 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
82 | — |
| SECONDARY Number of Participants With AE Stratified by Severity |
55; 27 | — |
| SECONDARY Number of Participants With Clinical Abnormal Laboratory Values |
4; 3; 3 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02587065). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.