Clinical trial NCT02949908: MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)
Official 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis
Rebif
Treatment Satisfaction Questionnaire for Medication Version II
Multiple Sclerosis International Quality of Life Questionnaire
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck B.V., Netherlands
First posted: 2016-10-31
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: RRMS participants who have discontinued their initial MS treatment and for whom MS treatment will be required according to the decision of the Health Care Professional and participant.

Brief summary: This is a prospective, multicenter, open label, uncontrolled, non-interventional, single arm study to measure treatment satisfaction of relapsing remitting MS (RRMS) participants on Rebif after discontinuing initial first-line treatment.


Eligibility 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 IFNβ-1a (Avonex®), pegylated interferon (Plegridy®), subcutaneous IFNβ-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 IFNβ-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.

Primary outcomes:
measure: Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
timeFrame: Month 6
measure: Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)
timeFrame: Month 12
Secondary outcomes:
measure: Annualized Relapse Rate (ARR)
timeFrame: Month 12
measure: Number of Participants With Adherence to Treatment
timeFrame: Month 6 and Month 12
measure: Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12
timeFrame: Month 6, Month 12
measure: Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation
timeFrame: Baseline
measure: Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)
timeFrame: up to 12 months
measure: Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Adherence
timeFrame: up to 12 months
measure: Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Reason for Discontinuation
timeFrame: up to 12 months
measure: Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Annualized Relapse Rate (ARR)
timeFrame: up to 12 months
measure: Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Adherence
timeFrame: up to 12 months
measure: Correlation Between Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) and Reason for Discontinuation
timeFrame: up to 12 months
measure: Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Adherence
timeFrame: up to 12 months
measure: Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscales and Reasons for Discontinuation
timeFrame: up to 12 months
measure: Change From Baseline in Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) Subscale Score at Month 6 and Month 12
timeFrame: Baseline, Month 6, Month 12
measure: Change From Baseline in Annualized Relapse Rate (ARR) at Month 12
timeFrame: Baseline, Month 12
measure: Correlation Between Annualized Relapse Rate (ARR) and Treatment Adherence
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Darmstadt
country: Germany
facility: Please Contact the Merck KGaA Communication Center
Study officials:
affiliation: Merck B.V., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: