Clinical trial NCT01128075: Treatment Adherence When Using RebiSmart™ in Relapsing Multiple Sclerosis Subjects
Official title: Multi-center, Two-arm Non-comparative, Observational, 96-week Phase IV Study to Evaluate Treatment Adherence When Using RebiSmart™ for Self-injection of Rebif® in Multi-dose Cartridges in Subjects With Relapsing Multiple Sclerosis (RMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
MS
Keywords: RebiSmart
Rebif
Adherence
Multidose
Relapsing Multiple Sclerosis
RMS
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: EMD Inc., Canada
First posted: 2010-05-21
Enrollment: 198
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: Community and Academic MS clinics

Brief summary: This is a multi-center, two-arm non-comparative, observational, 96 week Phase IV study to evaluate treatment adherence when using RebiSmart™ for self-injection of Rebif® in subjects with relapsing multiple sclerosis (RMS).

Subjects who have a confirmed diagnosis of RMS using McDonald Criteria and meet the eligibility criteria during a screening period of up to 28 days will be provided with an electronic self-injection device (RebiSmart™) to inject Rebif® for 96 weeks.

The main purpose of this study is to evaluate treatment adherence for subjects with RMS over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.


Eligibility criteria: Inclusion Criteria:

* Males and females between 18 and 65 years of age.
* Have RMS according to the revised McDonald Criteria.
* Subject is eligible for Rebif® therapy according to indications and clinical use in the Rebif® Product Monograph.
* Be willing and able to comply with the protocol requirements for the duration of the study.
* Have given written informed consent prior to entering the screening period.
* Must register with the Rebif® Multiple Support Program.
* Subjects previously on disease modifying drugs (DMDs) must be stable and not be experiencing any side effects related to the previous DMDs at the time of enrollment into the study, in the opinion of the investigator. Rebif® will be prescribed as per Product Monograph and a washout period will be left at the discretion of the investigator.

Exclusion Criteria:

* Have any disease other than MS that could better explain his/her signs and symptoms.
* Receive any other injectable medications on a regular basis during the week prior to the screening period or throughout the duration of the study. The administration of a single injection for treatment or prophylaxis of a condition unrelated to the subject's MS (e.g.,influenza or pneumococcus vaccination) will be acceptable.
* Are contraindicated for the use of Rebif® according to the Rebif® Product Monograph.
* Have a diagnosis of clinically isolated syndrome (CIS).
* Participation in any other investigational trial prior to 30 days of Study Day 1.
* Any visual or physical impairment that precludes the subject from self-injecting the treatment using RebiSmart™
* Have received previous treatment with Rebif within 5 years prior to screening.
* Subjects have any medical, psychiatric or other conditions that compromise his/her ability to understand the subject information, to give informed consent, to comply with the study protocol or to complete the study questionnaires.

Primary outcomes:
measure: Treatment adherence for RMS subjects over 24 weeks of treatment when using RebiSmart™ for self-injection of Rebif® in a multi-dose cartridge.
timeFrame: 24 weeks
Secondary outcomes:
measure: Long-term adherence in subjects with RMS over 96 weeks of treatment using RebiSmart for self-injection of Rebif® in multi-dose cartridge.
timeFrame: 96 weeks
measure: Treatment persistence by measuring treatment discontinuations
timeFrame: 96 weeks
measure: Treatment compliance
timeFrame: 96 weeks
measure: Comparison of subject treatment adherence between categories of cognitive function
timeFrame: 96 weeks
measure: Longitudinal changes in anxiety symptoms
timeFrame: 96 weeks
measure: Qualitative assessment of subjects' experience with RebiSmart
timeFrame: 96 weeks
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
Study officials:
affiliation: EMD Serono, a division of EMD Inc., Canada
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Devonshire VA, Feinstein A, Moriarty P. Adherence to interferon beta-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study. BMC Res Notes. 2016 Mar 8;9:148. doi: 10.1186/s13104-016-1948-z.