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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Enrollment 106
Recruitment Details

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  
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Period Title: Overall Study
Started 106
Completed 101
Not Completed 5
Reason Not Completed
Adverse Event             4
Protocol Violation             1
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Baseline Participants 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
<=18 years
0
   0.0%
Between 18 and 65 years
106
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants
41.7  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants
Female
65
  61.3%
Male
41
  38.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 106 participants
United States 21
Canada 16
Spain 24
Germany 26
Italy 14
Sweden 5
Diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 106 participants
75.5  (10.1)
Heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats/min
Number Analyzed 106 participants
74.9  (9.0)
Temperature  
Mean (Standard Deviation)
Unit of measure:  °C
Number Analyzed 106 participants
36.40  (0.43)
Thyroid Peroxidase antibody  
Mean (Standard Deviation)
Unit of measure:  IU/ml
Number Analyzed 106 participants
220  (181.9)
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 106 participants
118.4  (13.1)
Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score items 13-16   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants
9.5  (3.7)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants
4.8  (1.7)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 106 participants
11.1  (3.3)
[1]
Measure Description: 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.
1.Primary Outcome
Title The Number of Subjects Rating the Suitability of RebiSmart at the End of 12-week Treatment Period for Self-injecting Rebif® New Formulation (RNF).
Hide Description 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.
Time Frame End of 12 week treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
4 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 102
Measure Type: Number
Unit of Measure: participants
suitable or very suitable 73
a little suitable 21
not suitable at all 8
2.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 4
Hide Description Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
8.8  (3.9)
3.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 8
Hide Description Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
8.8  (3.8)
4.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Flu Like Symptom (FLS) Score Items 13-16 at End Week 12
Hide Description Intention to treat population. MSTCQ FLS Score items 13-16 has a best possible score of 4 and a worst possible score of 20.
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
9.0  (3.8)
5.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 4
Hide Description 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.
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
11.4  (3.2)
6.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 8
Hide Description 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.
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
11.3  (3.5)
7.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Site Reaction Score Items 17-20 at End Week 12
Hide Description 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.
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
11.4  (3.4)
8.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 4
Hide Description 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.
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
5.5  (2.4)
9.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 8
Hide Description 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.
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
6 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 100
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
5.2  (2.2)
10.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Global Side Effects Score Items 21-23 at End Week 12
Hide Description 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.
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
5.6  (2.6)
11.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 4
Hide Description 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)
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
3 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 103
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
0.2  (2.5)
12.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 8
Hide Description 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)
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 101
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
0.1  (1.9)
13.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Injection Issues Score Item 34 at End Week 12
Hide Description 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)
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: MSTCQ Score (units on a scale)
0.2  (2.0)
14.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 4
Hide Description 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.
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
21 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: participants
fewer injection site reactions 13
less injection pain 17
fewer flu-like symptoms 9
fewer physical side effects 5
overall convenience 50
15.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 8
Hide Description 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.
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
21 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: participants
fewer injection site reactions 8
less injection pain 13
fewer flu-like symptoms 6
fewer physical side effects 8
overall convenience 59
16.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Benefit Item 35 at End Week 12
Hide Description 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.
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
21 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 85
Measure Type: Number
Unit of Measure: participants
fewer injection site reactions 6
less injection pain 11
fewer flu-like symptoms 6
fewer physical side effects 5
overall convenience 63
17.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 4
Hide Description Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
4 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 102
Mean (Standard Deviation)
Unit of Measure: mm (on a scale)
30.2  (24.6)
18.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 8
Hide Description Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 101
Mean (Standard Deviation)
Unit of Measure: mm (on a scale)
30.8  (24.9)
19.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Scale Item 37 at End Week 12
Hide Description Intention to treat population. MSTCQ Pain Rating Scale item 37. Visual Analogue Scale 0mm (No pain) to 100mm (Worst possible pain)
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 106
Mean (Standard Deviation)
Unit of Measure: mm (on a scale)
30.0  (25.1)
20.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 4
Hide Description Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating
Time Frame at the end of week 4 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: participants
No pain 18
Mild 44
Discomforting 26
Distressing 11
Horrible Excruciating 2
21.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 8
Hide Description Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating
Time Frame at the end of week 8 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
5 subjects with missing values
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 101
Measure Type: Number
Unit of Measure: participants
No pain 17
Mild 46
Discomforting 25
Distressing 12
Horrible Excruciating 1
22.Secondary Outcome
Title Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ) Pain Rating Grade Item 38 at End Week 12
Hide Description Intention to treat population. MSTCQ Pain Rating Grade item 38. Rated as No pain; Mild; Discomforting; Distressing; or Horrible Excruciating
Time Frame at the end of week 12 of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description:
Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
Overall Number of Participants Analyzed 106
Measure Type: Number
Unit of Measure: participants
No pain 18
Mild 42
Discomforting 31
Distressing 11
Horrible Excruciating 4
23.Secondary Outcome
Title 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.
Hide Description 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
Time Frame at the end of weeks 4, 8, and 12 of treatment
Outcome Measure Data Not Reported
Time Frame The timeframe over which adverse events were collected was during the 12-week treatment period.
Adverse Event Reporting Description Intent to treat population. The Other Adverse Events table shows all adverse events occuring a frequency equal to or greater than the reporting threshold.
 
Arm/Group Title RebiSmart for Self-injection
Hide Arm/Group Description Rebif New Formulation 44 mg, 3 times a week by subcutaneous injection.
All-Cause Mortality
RebiSmart for Self-injection
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RebiSmart for Self-injection
Affected / at Risk (%) # Events
Total   6/106 (5.66%)    
Cardiac disorders   
Myocardial disorders * 1  1/106 (0.94%)  1
General disorders   
Adverse drug reaction * 1  1/106 (0.94%)  1
Hepatobiliary disorders   
Biliary colic * 1  1/106 (0.94%)  1
Infections and infestations   
Breast infection * 1  1/106 (0.94%)  1
Injury, poisoning and procedural complications   
Seroma * 1  1/106 (0.94%)  1
Vascular disorders   
Hypertensive crisis * 1  1/106 (0.94%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
RebiSmart for Self-injection
Affected / at Risk (%) # Events
Total   67/106 (63.21%)    
General disorders   
Adverse drug reaction * 1  1/106 (0.94%)  1
Chills * 1  3/106 (2.83%)  7
Fatigue * 1  1/106 (0.94%)  1
Impaired healing * 1  1/106 (0.94%)  1
Infuenza like illness * 1  22/106 (20.75%)  54
Injection site erythema * 1  2/106 (1.89%)  2
Injection site extravasation * 1  1/106 (0.94%)  1
Injection site irritation * 1  2/106 (1.89%)  2
Injection site pain * 1  3/106 (2.83%)  3
Pyrexia * 1  2/106 (1.89%)  2
Infections and infestations   
Borrelia infection * 1  1/106 (0.94%)  1
Breast infection * 1  1/106 (0.94%)  1
Bronchitis * 1  3/106 (2.83%)  3
Gastroenteritis * 1  2/106 (1.89%)  2
Influenza * 1  4/106 (3.77%)  4
Nasopharyngitis * 1  10/106 (9.43%)  15
Otitis media acute * 1  1/106 (0.94%)  1
Pharyngitis * 1  1/106 (0.94%)  1
Respiratory tract infection * 1  1/106 (0.94%)  1
Upper respiratory tract infection * 1  5/106 (4.72%)  6
Vulvovaginal mycotic infection * 1  1/106 (0.94%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/106 (1.89%)  2
Back pain * 1  1/106 (0.94%)  1
Muscle spasms * 1  1/106 (0.94%)  3
Myalgia * 1  3/106 (2.83%)  5
Neck pain * 1  1/106 (0.94%)  1
Pain in extremity * 1  2/106 (1.89%)  2
Nervous system disorders   
Facial palsy * 1  1/106 (0.94%)  1
Headache * 1  12/106 (11.32%)  25
Monoparesis * 1  1/106 (0.94%)  1
Neuralgia * 1  1/106 (0.94%)  1
Syncope vasovagal * 1  1/106 (0.94%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (11.0)
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.
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
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