MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02949908
• Date of registration: 17/10/2016
• Prospective Registration: Yes
• Primary sponsor: Merck KGaA, Darmstadt, Germany
• Public title: MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS) MESTRE-MS
• Scientific title: A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line Treatment
• Date of first enrolment: February 9, 2017
• Target sample size: 2
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02949908
• Study type: Observational

Countries of recruitment

Germany

Contacts

• Name: Medical Responsible
• Affiliation: Merck B.V., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, 18 to 65 years of age (both inclusive), at the time of informed
consent

- Participants diagnosed with RRMS according to McDonald criteria 2010

- Participants have discontinued treatment with dimethyl fumarate (Tecfidera),
teriflunomide (Aubagio), glatiramer acetate (Copaxone®), intramuscular IFNß-1a
(Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNß-1b (Betaferon®) or
fingolimod (Gilenya®) within 6 months prior to Visit 1

- Currently treated with Rebif using RebiSmart 2.0, for a maximum of 6 months prior
to Visit 1

- Participants have a score on the Expanded Disability Status Scale (EDSS) between
0 to 5.0 inclusive

- Participants willing and able to give informed consent.

Exclusion Criteria:

- Participants have known planned surgical procedures at the time of the informed
consent that will prevent adherence to treatment with Rebif through RebiSmart 2.0

- Participants diagnosed with primary progressive, secondary progressive, or progressive
relapsing MS

- pregnant or lactating, or planning to become pregnant subjects

- In the opinion of the Investigator has significant renal or hepatic impairment or
other significant disease (e.g., cognitive or visual impairment) that would compromise
adherence and completion of the study

- Reports any reason that he/she cannot complete the 1 year study

- Participants have a history of hypersensitivity to natural or recombinant interferon,
or any other component of the formulation

- Participants who contraindicated for the treatment with subcutaneous IFNß-1a therapy
as per summary of product characteristics or currently approved specific country
product information

- Participants have any other factor that in the opinion of the Investigator would make
the subject unsuitable for participation in this study

- Participants have significant psychiatric symptoms that, in the opinion of the
Investigator, would impact patient ability to comply with treatment recommendations.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Rebif

Primary Outcome(s)

Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) [Time Frame: Month 6]

Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) [Time Frame: Month 12]

Secondary Outcome(s)

Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation [Time Frame: up to 12 months]

Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation [Time Frame: up to 12 months]

Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence [Time Frame: up to 12 months]

Number of Participants With Adherence to Treatment [Time Frame: Month 6 and Month 12]

Annualized Relapse Rate (ARR) [Time Frame: Month 12]

Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12 [Time Frame: Baseline, Month 6, Month 12]

Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence [Time Frame: up to 12 months]

Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation [Time Frame: up to 12 months]

Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation [Time Frame: Baseline]

Change From Baseline in Annualized Relapse Rate (ARR) at Month 12 [Time Frame: Baseline, Month 12]

Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence [Time Frame: up to 12 months]

Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR) [Time Frame: up to 12 months]

Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence [Time Frame: up to 12 months]

Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR) [Time Frame: up to 12 months]

Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12 [Time Frame: Month 6, Month 12]

Secondary ID(s)

EMR200136_597

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merck B.V., Netherlands

Results

• Results available: Yes
• Date Posted: 18/01/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02949908