Multiple SclerosisPhase 3NCT00735007
12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.
A Phase 3 study testing Rebif® New Formulation (RNF) using RebiSmartTM in people with Multiple Sclerosis, run by EMD Serono at 6 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Rebif® New Formulation (RNF) using RebiSmartTM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Jul 2008to Jan 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United States1 site
US Local Medical Information
Rockland, Massachusetts, 02370
Canada1 site
Canada, Local Medical Information
Ontario, British Columbia, Quebec
About this study
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)
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:
Read more
- 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Rebif® New Formulation (RNF) using RebiSmartTM
- Keywords
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rebif® New Formulation (RNF) using RebiSmartTMDrug
RNF 44 mg, 3 times a week by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Rebif® New Formulation (RNF) using RebiSmartTM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of 12 week treatment period
Secondary outcomes (22)
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.
Measured: 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
Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12
Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.
Measured: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4
Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.
Measured: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8
Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12
Intention to treat population. MSTCQ InjectionSite Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.
Measured: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4
Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.
Measured: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8
Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12
Intention to treat population. MSTCQ Global Side Effects Score items 21-23 has a best possible score of 15 and a worst possible score of 3.
Measured: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4
Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)
Measured: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8
Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12
Intention to treat population. MSTCQ Injection Issues Score item 34: +5 is the best possible score (much better), -5 is the worst possible score (much worse), zero is neutral (no change)
Measured: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4
Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.
Measured: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8
Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12
Intention to treat population. MSTCQ Injection Issues Score item 35 - Most important benefit of the RebiSmart injection system: Fewer injection site reactions; less injection pain; fewer flu-like symptoms; fewer physical side effects; or overall convenience.
Measured: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4
Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)
Measured: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8
Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12
Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)
Measured: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4
Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating
Measured: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8
Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating
Measured: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12
Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating
Measured: at the end of week 12 of treatment
The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.
Information on these outcomes is shown separately above, apart from information on the incidence of injection site related adverse events which is shown in the Adverse Events section
Measured: at the end of weeks 4, 8, and 12 of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elisabetta Verdun di Cantogno, MD, Study director, Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735007
- Sponsor's protocol ID
- 28733
- Status last verified
- Oct 2013
- First submitted
- 12 Aug 2008
- Last updated
- 14 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 20433746
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00735007
- Acronym / sponsor ID
- 28733
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jan 2009 (actual)
- First posted
- 14 Aug 2008 (estimated)
- Results
- Posted 11 Aug 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Rebif® New Formulation (RNF) using RebiSmartTM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rebif® New Formulation (RNF) using RebiSmartTMRNF 44 mg, 3 times a week by subcutaneous injection. | Drug | 1 |
Primary outcome
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 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.
22 secondary outcomes
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4
Time frame: 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
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12
Time frame: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4
Time frame: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12
Time frame: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4
Time frame: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12
Time frame: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4
Time frame: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12
Time frame: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4
Time frame: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12
Time frame: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4
Time frame: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12
Time frame: at the end of week 12 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4
Time frame: at the end of week 4 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8
Time frame: at the end of week 8 of treatment
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12
Time frame: at the end of week 12 of treatment
The Incidence of Predefined Injection Site Reactions, MSTCQ Scores, Side Effects, McGill Pain Questionnaire, Visual Analog Scale, and Rating of Pain Regarding Injection Pain Following RNF Administration With RebiSmart at 12-week Treatment Period.
Time frame: at the end of weeks 4, 8, and 12 of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20433746Devonshire 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabetta Verdun di Cantogno, MD study director
Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rebif® New Formulation (RNF) using RebiSmartTM in people with Multiple Sclerosis, run by EMD Serono at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Canada, Germany, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00735007, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2013.