12-week Study to Evaluate RebiSmart™ Suitability for Self... | NCT00735007

NCT00735007

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Brief Summary

The Electronic Device - The RebiSmart™ is an electronic injection device that is being studied for the delivery of Merck Serono's 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 body's own natural human interferon, but is made outside the body by a process called "recombinant DNA technology". Merck Serono International S.A. (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 / 0.5 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 (e.g. 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.

Label	Type	Description	Intervention Names
1	Experimental		Drug: Rebif® New Formulation (RNF) using RebiSmartTM

Name	Type	Description	Arm Group Labels	Other Names
Rebif® New Formulation (RNF) using RebiSmartTM	Drug	RNF 44 mg, 3 times a week by subcutaneous injection.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).	RebiSmart was evaluated as "very suitable or suitable"; "a little suitable"; or "not suitable at all" for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer.	End of 12 week treatment period

Secondary Outcomes

Measure	Description	Time Frame
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4	Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.	at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females between 18 and 65 years of age, inclusive
Female subjects must be neither pregnant nor breast-feeding and must lack child-bearing potential, as defined by either:
- Post-menopausal or surgically sterile, or
- Using a highly effective method of contraception for the duration of the study. This is defined as a method that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, and includes for instance implants, injectables, combined oral contraceptives, intra-uterine device (IUD)s, sexual abstinence or vasectomised partner.
Have RMS according to the revised McDonald Criteria 2005
Have disease duration for at least 3 months
Are currently receiving RNF 44 mcg sc by Rebiject IITM (RII) tiw and have been consistently on therapy for a minimum of 6 weeks prior to Screening

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 patient's MS or the patient's RNF therapy (e.g., influenza or pneumococcus vaccination) will be acceptable
Receive any MS therapy other than Rebif / RNF (e.g., other disease-modifying drug [DMD]s: immunomodulatory , immunosuppressive agents or combination therapy) within 12 months prior to study enrolment or at any time during the study
Receive oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 30 days prior to SD1
Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 3 x upper limit of normal (ULN), or alkaline phosphatase > 2 x ULN, or total bilirubin > 2 x ULN if associated with any elevation of ALT or alkaline phosphatase
Have inadequate bone marrow reserve, defined as a white blood cell count less than 0.5 x lower limit of normal
Have moderate to severe renal impairment
History of any chronic pain syndrome
Any visual or physical impairment that precludes the subject self-injecting the treatment using the RebiSmartä

Name	Affiliation	Role
Elisabetta Verdun di Cantogno, MD	Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
US Local Medical Information		Rockland	Massachusetts	02370	United States
Canada, Local Medical Information

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20433746	Derived	Devonshire V, Arbizu T, Borre B, Lang M, Lugaresi A, Singer B, Verdun di Cantogno E, Cornelisse P. Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study. BMC Neurol. 2010 Apr 30;10:28. doi: 10.1186/1471-2377-10-28.

ID	Title	Description
FG000	RebiSmart for Self-injection	Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.

Baseline Characteristics Module

ID	Title	Description
BG000	RebiSmart for Self-injection	Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).

RebiSmart was evaluated as "very suitable or suitable"; "a little suitable"; or "not suitable at all" for self-injecting RNF. The Patient User Trial Questionnaire (UTQ) provides confidence in the ability to evaluate the suitability of the device and ease of understanding the different features of the RebiSmart during the training session and the overall subject impression of the injection administration. Subjects completed the Patient UTQ at Study Day1, Week4, and Week12. The Trainer User UTQ provides confidence in the ability to evaluate the suitability of the RebiSmart by the trainer.

4 subjects with missing values

Posted

Number

participants

End of 12 week treatment period

ID	Title	Description
OG000	RebiSmart for Self-injection	Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	RebiSmart for Self-injection	Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases