Ignite Creation Date:
2024-05-05 @ 7:46 PM
Last Modification Date:
2024-10-26 @ 9:53 AM
Study NCT ID:
NCT00735007
Status:
COMPLETED
Last Update Posted:
2013-11-14
First Post:
2008-08-12
Brief Title:
12-week Study to Evaluate RebiSmart Suitability for Self Injection in Relapsing Multiple Sclerosis
Sponsor:
EMD Serono
Organization:
EMD Serono
Study Overview
Official Title:
International Multicenter Single-arm Open-label 12-week Phase IIIb Study to Evaluate RebiSmart Suitability for Self Injection of Rebif New Formulation RNF in Multidose Cartridges in Patients With Relapsing Form of Multiple Sclerosis RMS
Status:
COMPLETED
Status Verified Date:
2013-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Electronic Device - The RebiSmart is an electronic injection device that is being studied for the delivery of Merck Seronos Rebif New Formulation The RebiSmart device is a stand-alone hand-held device with internal power supply It is used for subcutaneous under the skin injections with single-use sterile disposable needles The device will be kept in a storage box and placed in the refrigerator after each use
The key features of the RebiSmart are as follows
Battery powered electromechanical automatic injector
Automatic needle attachment and detachment
Hidden needle before and after injection
Injection can only be initiated by pressing the injection button when in contact with the skin
Automatic needle insertion and injection of the preset dose into the subcutaneous under the skin tissue
Adjustable injection comfort parameters Injection depth needle insertion speed medication injection speed and time that the needle remains in the skin
Cartridges with 3 doses of Rebif New Formulation and
Several other electronic functions including history date and time of cartridge changes and injections
The Study Drug - Rebif New Formulation RNF Rebif is a medicine that is part of a family of proteins called interferon beta-1a IFN-β-1a molecules that play an important role in the immune system and help limit the damage that occurs with multiple sclerosis MS The interferon in Rebif is like your bodys own natural human interferon but is made outside the body by a process called recombinant DNA technology Merck Serono International SA the maker of Rebif has recently updated the method to make Rebif and it is referred to as Rebif New Formulation RNF
For the purpose of this study the form of Rebif New Formulation RNF will differ slightly from the one you currently receive RNF will be supplied in pre-filled cartridges containing three doses of 44mcg 05 ml IFN-β-1a This is the amount required for you to administer during the course of one full week of treatment The dosage of RNF 44mcg is injected under the skin three times per week The RebiSmart device will be provided for the administration of RNF RNF should be administered if possible at the same time preferably in the late afternoon or evening on the same three days eg Monday Wednesday and Friday with at least 48 hours break between each administration You will be asked to record the time and date of each injection in the diary cards provided You will be taught how to properly use the device to inject the medication You will also be reminded to rotate injection sites and advised on the importance of avoiding already inflamed areas for future injections
The goals of this research trial are
To evaluate if the electronic device can be used if it is suitable by MS patients performing self-injections of Rebif New Formulation
To determine MS patients overall satisfaction of the new RebiSmart device by determining their ease in using it how often side effects happen flu-like symptoms injection site reactions and any other overall injection issues that they may experience while on the trial This will be done by completion of the Patient User Trial Questionnaire and the Multiple Sclerosis Treatment Concern Questionnaire MSTCQ
To evaluate specific features of the RebiSmart device from the answers MS patients provide in the User Trial Questionnaire The MS patient and the person who will trains them on the proper use of the device will complete this questionnaire
The key features of the RebiSmart are as follows
Battery powered electromechanical automatic injector
Automatic needle attachment and detachment
Hidden needle before and after injection
Injection can only be initiated by pressing the injection button when in contact with the skin
Automatic needle insertion and injection of the preset dose into the subcutaneous under the skin tissue
Adjustable injection comfort parameters Injection depth needle insertion speed medication injection speed and time that the needle remains in the skin
Cartridges with 3 doses of Rebif New Formulation and
Several other electronic functions including history date and time of cartridge changes and injections
The Study Drug - Rebif New Formulation RNF Rebif is a medicine that is part of a family of proteins called interferon beta-1a IFN-β-1a molecules that play an important role in the immune system and help limit the damage that occurs with multiple sclerosis MS The interferon in Rebif is like your bodys own natural human interferon but is made outside the body by a process called recombinant DNA technology Merck Serono International SA the maker of Rebif has recently updated the method to make Rebif and it is referred to as Rebif New Formulation RNF
For the purpose of this study the form of Rebif New Formulation RNF will differ slightly from the one you currently receive RNF will be supplied in pre-filled cartridges containing three doses of 44mcg 05 ml IFN-β-1a This is the amount required for you to administer during the course of one full week of treatment The dosage of RNF 44mcg is injected under the skin three times per week The RebiSmart device will be provided for the administration of RNF RNF should be administered if possible at the same time preferably in the late afternoon or evening on the same three days eg Monday Wednesday and Friday with at least 48 hours break between each administration You will be asked to record the time and date of each injection in the diary cards provided You will be taught how to properly use the device to inject the medication You will also be reminded to rotate injection sites and advised on the importance of avoiding already inflamed areas for future injections
The goals of this research trial are
To evaluate if the electronic device can be used if it is suitable by MS patients performing self-injections of Rebif New Formulation
To determine MS patients overall satisfaction of the new RebiSmart device by determining their ease in using it how often side effects happen flu-like symptoms injection site reactions and any other overall injection issues that they may experience while on the trial This will be done by completion of the Patient User Trial Questionnaire and the Multiple Sclerosis Treatment Concern Questionnaire MSTCQ
To evaluate specific features of the RebiSmart device from the answers MS patients provide in the User Trial Questionnaire The MS patient and the person who will trains them on the proper use of the device will complete this questionnaire
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None