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

Multiple Sclerosis, Relapsing-remitting Clinical Trial

— ADHERQOL  

Official title:

A Prospective, Observational, International, Multi-center Study to Measure the Relationship Between Relapse and Adherence in Relapsing-Remitting Multiple Sclerosis (RRMS) Patients Treated With Rebismart®2.0 + MSdialog™, Assessing Quality of Life (ADHERQOL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02394782
• Other study ID #: EMR200136-591
• Status: Terminated
• Phase: N/A
• First received: March 16, 2015
• Last updated: April 22, 2016
• Start date: February 2015
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationAustralia: Human Research Ethics CommitteeAustria: Austrian Federal Office for Safety in Health CareBelgium: Ethics CommitteeCanada: Ethics Review CommitteeDenmark: Danish Health and Medicines AuthorityFinland: Finnish Medicines AgencyFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: The Commission nationale de l’informatique et des libertésGermany: Ethics CommissionItaly: Ethics CommitteeItaly: The Italian Medicines AgencyPortugal: Data Protection AgencyPortugal: Ethics Committee for Clinical ResearchSpain: Agencia Española de Medicamentos y Productos SanitariosSpain: Ethics CommitteeSweden: Central Ethical Review BoardSwitzerland: EthikkommissionNetherlands: Drugs Advertising Code FoundationUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Germany	Please contact the Merck KGaA Communication Center	Darmstadt

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Annualized Relapse Rate	Annualized relapse rate is calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.	Months 12 and 24	No
Secondary	Multiple Sclerosis International Quality of Life (MusiQoL) and Multiple Sclerosis Quality of Life Inventory (MSQLI) Subscale Scores for MSdialog™	Normalized scores are calculated in the range of 0 - 100; where 0 = the worst QoL status and 100 = the best QoL status (as self-assessed by the subject).	Up to 24 months	No