Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)

NCT02394782 | Terminated

• 1 other identifier: EMR200136-591
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.

Conditions

Multiple Sclerosis, Relapsing-remitting

Keywords

Multiple sclerosis, relapsing-remitting; Rebif; Interferon beta-1a; RebiSmart®2.0; MSdialog™

Outcome Measures

Primary Outcomes (1)

• Percentage of Relapse-free Subjects

  Relapse is defined as an increase of 2 points in at least one functional system of the expanded disability status scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, lasting for at least 24 hours and to have been preceded by at least 30 days of clinical stability or improvement.

  Up to 24 months

Secondary Outcomes (2)

• Annualized Relapse Rate

  Months 12 and 24

• Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™

  Up to 24 months

Study Arms (1)

Relapsing-remitting Multiple Sclerosis

Device: RebiSmart®2.0; Device: MSdialog™

Interventions

RebiSmart®2.0 DEVICE

Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.

Relapsing-remitting Multiple Sclerosis

MSdialog™ DEVICE

Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.

Relapsing-remitting Multiple Sclerosis

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

Participating sites will identify and recruit eligible subjects using appropriate recruitment strategies in accordance with any local approvals/regulations for observational studies e.g. via clinics, referrals, advertisements, patient databases etc.

You may qualify if:

• Diagnosed with RRMS according to McDonald criteria 2010
• Relapse free within 30 days before Baseline data collection
• Treatment with Rebif for 6 months or more prior to informed consent
• Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent)
• Females of childbearing potential must be willing to use appropriate contraception for the duration of the study
• EDSS score less than (\<) 6
• Written informed consent obtained prior to any protocol-required data collection

You may not qualify if:

• Participation in other studies within 30 days before Baseline
• Female who is pregnant or breast feeding
• Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice)
• Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC)
• Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to informed consent

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead

Study Sites (1)

Please contact the Merck KGaA Communication Center

Darmstadt, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

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

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2015
• First Posted: March 20, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 25, 2016

Record last verified: 2016-04

Locations

DE (1)