The Multicenter, Open-label, Single-use Autoinjector Convenience Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00958009 |
Recruitment Status :
Completed
First Posted : August 13, 2009
Results First Posted : December 30, 2010
Last Update Posted : August 7, 2013
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Sponsor:
EMD Serono
Information provided by:
EMD Serono
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label) |
Condition |
Multiple Sclerosis |
Intervention |
Device: Rebidose® |
Enrollment | 109 |
Participant Flow
Recruitment Details | 109 subjects were recruited from 12 US clinics in the US during the trial period Oct 2009 to April 2010. |
Pre-assignment Details | 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). |
Arm/Group Title | RMS Subject Disposition |
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Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication |
Period Title: Overall Study | |
Started | 109 |
Completed | 107 |
Not Completed | 2 |
Reason Not Completed | |
Adverse Event | 1 |
Subject found device difficult to use | 1 |
Baseline Characteristics
Arm/Group Title | RMS Subject Disposition | |
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Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication | |
Overall Number of Baseline Participants | 109 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 109 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
109 100.0%
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>=65 years |
0 0.0%
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 109 participants | |
46.0 (9.32) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 109 participants | |
Female |
76 69.7%
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Male |
33 30.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 109 participants |
109 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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.
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 |
EMail: | Fernando.dangond@emdserono.com |
Responsible Party: | Fernando Dangond, , Senior Director, Medical Affairs Neurology, EMD Serono, Inc. |
ClinicalTrials.gov Identifier: | NCT00958009 |
Other Study ID Numbers: |
29651 |
First Submitted: | August 12, 2009 |
First Posted: | August 13, 2009 |
Results First Submitted: | December 1, 2010 |
Results First Posted: | December 30, 2010 |
Last Update Posted: | August 7, 2013 |