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NCT00735007 · ClinicalTrials.gov registry record · Phase 3
12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.
A Phase 3 study, sponsored by EMD Serono.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT00735007 is a Phase 3 study that has completed, run by EMD Serono. The registered enrollment target is 106 participants.
The verdict
NCT00735007, a Phase 3 study, has completed, sponsored by EMD Serono.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study 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
Interventions
- DRUG Rebif® New Formulation (RNF) using RebiSmartTM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2008-07 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00735007
The ClinicalTrials.gov registry entry for NCT00735007 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EMD Serono, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rebif® New Formulation (RNF) using RebiSmartTM is the first listed.
NCT00735007 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00735007 about?
NCT00735007 is a clinical study titled "12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.". 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 s...
What is the current status of trial NCT00735007?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2008-07.
What interventions are being tested in trial NCT00735007?
The interventions under investigation include: Rebif® New Formulation (RNF) using RebiSmartTM (DRUG).
Who is sponsoring clinical trial NCT00735007?
This trial is sponsored by EMD Serono, which has 71 total clinical trials registered on ClinicalTrials.gov.
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