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

NCT02949908 | Terminated Results DMC

• 1 other identifier: EMR200136_597
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Relapsing Remitting Multiple Sclerosis; Rebif; Treatment Satisfaction Questionnaire for Medication Version II; Multiple Sclerosis International Quality of Life Questionnaire

Outcome Measures

Primary Outcomes (2)

• Treatment Satisfaction Score Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)

  TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.

  Month 6

• Treatment Satisfaction Determined With Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II)

  TSQM v II is designed as a general measure of treatment satisfaction with medication, suitable for use across a wide variety of medication types and illness conditions. It consists 11 question items. Participants were asked to assess their level of satisfaction taking all things into account. Participants were to respond about their satisfaction or dissatisfaction with medication they are taking on a scale ranging from 1 to 7, where 1= Extremely Dissatisfied, 2=Very Dissatisfied, 3=Dissatisfied, 4=Somewhat Satisfied, 5=Satisfied, 6=Very Satisfied, 7=Extremely Satisfied.

  Month 12

Secondary Outcomes (15)

• Annualized Relapse Rate (ARR)

  Month 12

• Number of Participants With Adherence to Treatment

  Month 6 and Month 12

• Multiple Sclerosis International Quality of Life Questionnaire (MusiQoL) Score at Month 6 and 12

  Month 6, Month 12

• Number of Participants Discontinued From Initial MS Treatment (Oral or Injectable) by Reason for Discontinuation

  Baseline

• Correlation Between Treatment Satisfaction Questionnaire for Medication Version II (TSQM v II) and Annualized Relapse Rate (ARR)

  up to 12 months

Study Arms (1)

Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)

Drug: Rebif

Interventions

Rebif DRUG

Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.

Also known as: IFNβ-1b

Rebif in Relapsing-Remitting Multiple Sclerosis (RRMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck B.V., Netherlands: collaborator

Study Sites (1)

Please Contact the Merck KGaA Communication Center

Darmstadt, 64293, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Interventions

Interferon beta-1a

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Interferon-beta; Interferon Type I; Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

The study was prematurely terminated due to low recruitment (only 2 participants were enrolled). Therefore, no statistical analysis was performed on the limited data which was collected during the study.

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Healthcare, a business of Merck KGaA, Darmstadt, Germany

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck B.V., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 31, 2016
• Study Start: February 9, 2017
• Primary Completion: August 25, 2017
• Study Completion: August 25, 2017
• Last Updated: January 18, 2019
• Results First Posted: January 18, 2019

Record last verified: 2018-07

Locations

DE (1)