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12-week Study to Evaluate RebiSmart™ Suitability for Self Injection in Relapsing Multiple Sclerosis.

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ClinicalTrials.gov Identifier: NCT00735007
Recruitment Status : Completed
First Posted : August 14, 2008
Results First Posted : August 11, 2010
Last Update Posted : November 14, 2013
Sponsor:
Information provided by (Responsible Party):
EMD Serono

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Intervention: Drug: Rebif® New Formulation (RNF) using RebiSmartTM

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

First Patient First Visit : 30 July 2008 Last Patient Last Visit: 27 January 2009

15 specialist neurology centres in 6 countries: Canada (3 sites), Germany(4 sites) , Italy (2 sites) , Spain(3 sites), Sweden (1 sites), USA(2 sites)


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
RebiSmart for Self-injection Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.

Participant Flow:   Overall Study
    RebiSmart for Self-injection
STARTED   106 
COMPLETED   101 
NOT COMPLETED   5 
Adverse Event                4 
Protocol Violation                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RebiSmart for Self-injection Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.

Baseline Measures
   RebiSmart for Self-injection 
Overall Participants Analyzed 
[Units: Participants]
 106 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   106 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 41.7  (9.3) 
Gender 
[Units: Participants]
 
Female   65 
Male   41 
Region of Enrollment 
[Units: Participants]
 
United States   21 
Canada   16 
Spain   24 
Germany   26 
Italy   14 
Sweden   5 
Diastolic blood pressure 
[Units: mmHg]
Mean (Standard Deviation)
 75.5  (10.1) 
Heart rate 
[Units: Beats/min]
Mean (Standard Deviation)
 74.9  (9.0) 
Temperature 
[Units: °C]
Mean (Standard Deviation)
 36.40  (0.43) 
Thyroid Peroxidase antibody 
[Units: IU/ml]
Mean (Standard Deviation)
 220  (181.9) 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 118.4  (13.1) 
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score items 13-16 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 9.5  (3.7) 
[1] Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score items 21-23 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.8  (1.7) 
[1] 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.
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score items 17-20 [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.1  (3.3) 
[1] Intention to treat population. MSTCQ Injection Site Reaction Score items 17-20 has a best possible score of 4 and a worst possible score of 20.


  Outcome Measures

1.  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).   [ Time Frame: End of 12 week treatment period ]

2.  Secondary:   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 ]

3.  Secondary:   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 ]

4.  Secondary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   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 ]

13.  Secondary:   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 ]

14.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4   [ Time Frame: at the end of week 4 of treatment ]

15.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8   [ Time Frame: at the end of week 8 of treatment ]

16.  Secondary:   Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12   [ Time Frame: at the end of week 12 of treatment ]

17.  Secondary:   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 ]

18.  Secondary:   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 ]

19.  Secondary:   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 ]

20.  Secondary:   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 ]

21.  Secondary:   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 ]

22.  Secondary:   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 ]

23.  Secondary:   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 not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Elisabetta Verdun di Cantogno
Organization: Merck Serono International, S.A., an affiliate of Merck KGaA, Darmstadt, Germany
phone: +41 22 414 4887
e-mail: elisabetta.verdun@merckserono.net


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT00735007     History of Changes
Other Study ID Numbers: 28733
First Submitted: August 12, 2008
First Posted: August 14, 2008
Results First Submitted: July 14, 2010
Results First Posted: August 11, 2010
Last Update Posted: November 14, 2013