The Multicenter, Open-label, Single-use Autoinjector Convenience Study

This study has been completed.

Sponsor:

Information provided by:

EMD Serono

ClinicalTrials.gov Identifier:

NCT00958009

First received: August 12, 2009

Last updated: August 2, 2013

Last verified: August 2013

History of Changes

Results First Received: December 1, 2010

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment; Masking: Open Label
Condition:	Multiple Sclerosis
Intervention:	Device: Rebidose®

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
109 subjects were recruited from 12 US clinics in the US during the trial period Oct 2009 to April 2010.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who signed informed consent and satisfied the eligibility critera at screening returned to the clinic on study day 1 to begin treatment. All subjects participating in the trial received Rebif 44 mcg subcutaneious (sc, three times per week (tiw) using the single-use autoinjector (SA).

Reporting Groups

	Description
RMS Subject Disposition	Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication

Participant Flow: Overall Study

	RMS Subject Disposition
STARTED	109
COMPLETED	107
NOT COMPLETED	2
Adverse Event	1
Subject found device difficult to use	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
RMS Subject Disposition	Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication

Baseline Measures

	RMS Subject Disposition
Overall Participants Analyzed [Units: Participants]	109

Age [Units: Participants]
<=18 years	0
Between 18 and 65 years	109
>=65 years	0

Age [Units: Years] Mean (Standard Deviation)	46.0 (9.32)

Gender [Units: Participants]
Female	76
Male	33

Region of Enrollment [Units: Participants]
United States	109

Outcome Measures

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1. Primary:

Proportion of Relapsing Multiple Sclerosis (RMS) Subjects Rating the Single-use Autoinjector as 'Easy to Use' or 'Very Easy to Use' for Self-injection in a User Trial Questionnaire [ Time Frame: at 12 weeks ]

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2. Secondary:

Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes. [ Time Frame: at 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Neither Institution nor any Principal Investigators shall publish or present any results from such Study to any third parties until: (i) EMD Serono publishes the results from all sites participating in such Study; (ii) Institution receives notification from EMD Serono that publication of the multi-site results is no longer planned; or (iii) twenty-four (24) months following the completion of the multi-site study at all sites, whichever occurs first.

Results Point of Contact:

Name/Title: Fernando Dangond, MD
Organization: EMD Serono, Inc.
phone: 781-681-2348
e-mail: Fernando.dangond@emdserono.com

Responsible Party:	Fernando Dangond, , Senior Director, Medical Affairs Neurology, EMD Serono, Inc.
ClinicalTrials.gov Identifier:	NCT00958009 History of Changes
Other Study ID Numbers:	29651
Study First Received:	August 12, 2009
Results First Received:	December 1, 2010
Last Updated:	August 2, 2013

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