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

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
Sponsor:
Information provided by:
EMD Serono

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Multiple Sclerosis
Intervention Device: Rebidose®
Enrollment 109
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
Hide Arm/Group Description 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
Arm/Group Title RMS Subject Disposition
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
<=18 years
0
   0.0%
Between 18 and 65 years
109
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants
46.0  (9.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants
Female
76
  69.7%
Male
33
  30.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 109 participants
109
1.Primary Outcome
Title 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
Hide Description Data from the User Trial Questionnaire, Question 14 (Overall, how do you rate your experience with using the injection device?) Mean and confidence interval refer to proportion of subjects responding positively to question. Missing values were replaced with worst case response.
Time Frame at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the all enrolled analysis set who received at least one dose of investigational medicinal product (IMP) were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.
Arm/Group Title RMS Subject Disposition
Hide Arm/Group Description:
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 Participants Analyzed 109
Mean (95% Confidence Interval)
Unit of Measure: Proportion of subjects
0.86
(0.80 to 0.93)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection RMS Subject Disposition
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter mean positive response
Estimated Value 0.86
Confidence Interval (2-Sided) 95%
0.80 to 0.93
Estimation Comments Confidence Interval calculated from normal approximation to the binomial. The primary objective was met if the lower bound of the 95% confidence interval is >0.50.
2.Secondary Outcome
Title Multiple Secondary Endpoints Were Assessed, Based on Questions From the User Trial Questionnaire Related to the Single-use Autoinjector Device Use-related Outcomes.
Hide Description The User Trial Questionnaire was used to assess the ease of use, functional reliability, overall satisfaction with device attributes, convenience, safety and portability of the device. Mean and confidence intervals refer to proportion of subjects responding positively to question. Secondary endpoints presented for decriptive purposes only thus no statistical analysis performed.
Time Frame at 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in the all enrolled analysis set who received at least one dose of IMP were included in the ITT analysis set. This analysis set was used to analyze the primary and secondary variables and all safety data.
Arm/Group Title RMS Subject Disposition
Hide Arm/Group Description:
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 Participants Analyzed 109
Mean (95% Confidence Interval)
Unit of Measure: Proportion of subjects
Device makes injections simple
0.83
(0.77 to 0.90)
Allows easy access to skin injection sites
0.78
(0.70 to 0.86)
Helps me self-administer injections
0.83
(0.75 to 0.90)
Ease of pushing device against skin
0.76
(0.68 to 0.84)
Ease of holding device during injection
0.77
(0.69 to 0.85)
Able to often or always administer full injection
0.96
(0.93 to 1.00)
Satisfaction with size of device
0.61
(0.51 to 0.70)
Satisfaction with ease of removing cap from device
0.87
(0.81 to 0.93)
Satisfaction with ease of activating button
0.78
(0.70 to 0.86)
Satisfaction with time to inject medicine
0.83
(0.75 to 0.90)
Satisfaction with ability to see post injection
0.81
(0.73 to 0.88)
Rate convenience of device
0.74
(0.66 to 0.83)
Rate how reliable injection device was
0.79
(0.71 to 0.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RMS Subject Disposition
Hide Arm/Group Description Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
All-Cause Mortality
RMS Subject Disposition
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
RMS Subject Disposition
Affected / at Risk (%) # Events
Total   4/109 (3.67%)    
Cardiac disorders   
Angina pectoris  1  1/109 (0.92%)  1
Gastrointestinal disorders   
Pancreatitis acute  1  1/109 (0.92%)  1
General disorders   
Chest Pain  1  1/109 (0.92%)  1
Nervous system disorders   
Convulsion  1  1/109 (0.92%)  1
Vascular disorders   
Hypertension  1  1/109 (0.92%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RMS Subject Disposition
Affected / at Risk (%) # Events
Total   83/109 (76.15%)    
General disorders   
Influenza like illness  1  26/109 (23.85%)  26
Injection site erythema  1  39/109 (35.78%)  39
Injection site haematoma  1  13/109 (11.93%)  13
Injection site pain  1  27/109 (24.77%)  27
Injection site swelling  1  8/109 (7.34%)  8
Infections and infestations   
Upper respiratory tract infection  1  6/109 (5.50%)  6
Nervous system disorders   
Headache  1  7/109 (6.42%)  7
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDra 13.0
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.
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
Layout table for Results Point of Contact information
Name/Title: Fernando Dangond, MD
Organization: EMD Serono, Inc.
Phone: 781-681-2348
EMail: Fernando.dangond@emdserono.com
Layout table for additonal information
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