Clinical Trials

Evaluating satisfaction and quality of life who have switched to low frequency injectable therapy

Type of Study/Intervention

Drug

Recruitment Status

Recruiting

Form of MS

Relapsing Remitting

Brief summary

The aim of this study is to help inform therapeutic decisions by evaluating the impact on treatment satisfaction and quality of life when patients start on the low-frequency injectable PLEGRIDY after switching from another injectable therapy. The results may influence patient preferences when the decision is made to switch therapies. This is an open-label, single arm, non-interventional phase 4 study.

Primary Objective:  The primary objective of the study is to investigate the treatment satisfaction levels of patients switching to PLEGRIDY as recorded through patient-reported outcomes (PROs) in patients with RRMS.

Additional Objectives: To understand the parameters that are most affected in the switch period to PLEGRIDY, from the perspective of PRO quality of life (QoL) measures. Specifically, the physical versus mental component scores.

Primary Endpoint: Change in convenience score from the Treatment Satisfaction Questionnaire for Medication (TSQM) from baseline to Week 24.

Additional Endpoints – Change from baseline to Week 24 in:
·         Effectiveness score from the TSQM
·         Overall score from the TSQM
·         The psychological impact score from  the MSIS-29
·         Cognitive impairment using the Multiple Sclerosis Neuropsychological Screening Questionnaire (MSNQ)
·         Beck Depression Inventory-Fast screen (BDI FS)

Study Population:
This study will be conducted in patients with RRMS, aged 18-65 years, who are switching from another injectable disease modifying therapy (DMT) to PLEGRIDY. Patients must have EDSS between 0 and 5.5 on their current therapy before switching to PLEGRIDY.

Inclusion Criteria:

·         Ability to understand the purpose and risks of the study and provide signed and dated informed consent and
authorization to use protected health information (PHI) in accordance with national and local privacy regulations
·         Diagnosis of RRMS
·         Currently taking an injectable interferon (interferon-β 1a or interferon-β 1b) or glatiramer acetate for RRMS
·         Qualify for PBS criteria for PLEGRIDY
·         EDSS ranging from 0 to 5.5
·         Age 18-65 years
·         Own and agree to use a smart device to complete the study questionnaires

Exclusion Criteria:

Candidates will be excluded from study entry if any of the following exclusion criteria exist.
·         Unable or unwilling to provide informed consent
·         Other forms of MS
·         EDSS >5.5
·         Currently being treated with, fingolimod, teriflunomide dimethyl fumarate, natalizumab or alemtuzumab.

Anticipated start date

Currently running

Recruitment status

Recruiting

Recruitment contacts

Study Medical Representative: Dr David Ali

Contact number +61 427 174 702

Region

NSW/SA/VIC/QLD/WA/TAS

 

 

 

Trial number

AUS-PEG-15-10872

 Ethics Approval

Yes

Last updated

16/03/17

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