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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02394782
Other study ID # EMR200136-591
Secondary ID
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


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
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