NCT00735007

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)

Completed Phase 3 Results posted Last updated 21 October 2013

What this trial tests

Phase 3 trial testing Rebif® New Formulation (RNF) using RebiSmartTM in Multiple Sclerosis in 106 participants. Completed.

Timeline

1 July 2008

Primary endpoint
1 January 2009

Quick facts

Lead sponsor	EMD Serono
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	106
Start date	1 July 2008
Primary completion	1 January 2009
Sites	6 locations across United States, Canada, Germany, Italy, Spain, Sweden

Drugs / interventions tested

• Rebif® New Formulation (RNF) using RebiSmartTM — full drug profile →

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

EMD Serono — full company profile →

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).
  Time frame: End of 12 week treatment period
  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 administ

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Devonshire V, Arbizu T, Borre B, Lang M, et al · · 2010 · cited 43× · PMID 20433746 · DOI 10.1186/1471-2377-10-28