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A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome (CIS-ON)

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ClinicalTrials.gov Identifier: NCT00287079
Recruitment Status : Completed
First Posted : February 6, 2006
Results First Posted : April 4, 2012
Last Update Posted : December 27, 2013
Sponsor:
Collaborator:
EMD Serono Canada Inc.
Information provided by (Responsible Party):
Merck KGaA, Darmstadt, Germany

Study Type Interventional
Study Design Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Clinically Isolated Syndrome
Interventions Drug: Rebif®
Other: No Treatment
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rebif 44 Mcg No Treatment
Hide Arm/Group Description Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly. Participants in this group did not receive any treatment.
Period Title: Overall Study
Started 32 3
Completed 10 2
Not Completed 22 1
Reason Not Completed
Qualifying relapse             12             1
Non-qualifying relapse             1             0
Adverse Event             5             0
Protocol Violation             1             0
Other             3             0
Arm/Group Title Rebif 44 Mcg No Treatment Total
Hide Arm/Group Description Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly. Participants in this group did not receive any treatment. Total of all reporting groups
Overall Number of Baseline Participants 32 3 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 3 participants 35 participants
36.30  (9.68) 35.30  (13.32) 35.80  (11.50)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 3 participants 35 participants
Female
19
  59.4%
3
 100.0%
22
  62.9%
Male
13
  40.6%
0
   0.0%
13
  37.1%
1.Primary Outcome
Title Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
Hide Description CDMS was defined by the occurrence of a second exacerbation or relapse over 96 weeks in participants who presented with Clinically Isolated Syndrome (CIS) accompanied by an abnormal Magnetic Resonance Imaging (MRI) scan. Time was calculated from the date of the stabilization of the baseline CIS episode to the qualifying relapse for the CDMS.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Two participants had negative time from stabilization and CDMS relapse and were excluded from the Kaplan-Meier analysis.
Arm/Group Title Rebif 44 Mcg No Treatment
Hide Arm/Group Description:
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
Participants in this group did not receive any treatment.
Overall Number of Participants Analyzed 30 3
Mean (Standard Error)
Unit of Measure: Month
15.6  (1.23) 17.0 [1]   (NA)
[1]
Standard Error not analyzed due to limited number of participants
2.Secondary Outcome
Title Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
Hide Description CDMS was defined as the occurrence of a second exacerbation over 96 weeks in participants who presented with CIS accompanied by an abnormal MRI scan.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population.
Arm/Group Title Rebif 44 Mcg No Treatment
Hide Arm/Group Description:
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
Participants in this group did not receive any treatment.
Overall Number of Participants Analyzed 32 3
Measure Type: Number
Unit of Measure: Percentage of participants
37.5 33.3
3.Secondary Outcome
Title Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description AE: any new untoward medical occurrence/worsening of pre-existing medical condition, whether or not related to study drug. SAE: any AE that resulted in death; was life threatening; resulted in persistent/significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; or was a medically important condition.
Time Frame Up to Week 96
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population: All participants in Treatment group who received at least 1 dose of Rebif® and all participants in observational group who had at least 1 post-baseline visit were included in ITT population. Adverse events were not captured for "No Treatment" group.
Arm/Group Title Rebif 44 Mcg No Treatment
Hide Arm/Group Description:
Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
Participants in this group did not receive any treatment.
Overall Number of Participants Analyzed 32 0
Measure Type: Number
Unit of Measure: percentage of participants
100
Time Frame Up to Week 96
Adverse Event Reporting Description AE: any untoward medical occurrence in form of signs, symptoms, abnormal laboratory findings, or diseases that emerges or worsens relative to baseline during a clinical study with an Investigational Medicinal Product (IMP), regardless of causal relationship and even if no IMP has been administered. AE were not captured for "No Treatment" group.
 
Arm/Group Title Rebif 44 Mcg No Treatment
Hide Arm/Group Description Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly. Participants in this group did not receive any treatment.
All-Cause Mortality
Rebif 44 Mcg No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Rebif 44 Mcg No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   1/32 (3.13%)   0/0 
Blood and lymphatic system disorders     
Mild Leucopenia *  1/32 (3.13%)  0/0 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rebif 44 Mcg No Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   32/32 (100.00%)   0/0 
Eye disorders     
Visual Disturbance *  3/32 (9.38%)  0/0 
Gastrointestinal disorders     
Constipation *  2/32 (6.25%)  0/0 
Diarrhoea *  2/32 (6.25%)  0/0 
Nausea *  10/32 (31.25%)  0/0 
Stomach Discomfort *  2/32 (6.25%)  0/0 
Vomiting *  3/32 (9.38%)  0/0 
General disorders     
Chills *  16/32 (50.00%)  0/0 
Fatigue *  17/32 (53.13%)  0/0 
Influenza like illness *  7/32 (21.88%)  0/0 
Injection site bruising *  3/32 (9.38%)  0/0 
Injection site discomfort *  2/32 (6.25%)  0/0 
Injection site erythema *  5/32 (15.63%)  0/0 
Injection site irritation *  4/32 (12.50%)  0/0 
Injection site pain *  3/32 (9.38%)  0/0 
Pain *  12/32 (37.50%)  0/0 
Pyrexia *  4/32 (12.50%)  0/0 
Infections and infestations     
Influenza *  3/32 (9.38%)  0/0 
Nasopharyngitis *  9/32 (28.13%)  0/0 
Injury, poisoning and procedural complications     
Contusion *  3/32 (9.38%)  0/0 
Musculoskeletal and connective tissue disorders     
Arthralgia *  4/32 (12.50%)  0/0 
Myalgia *  2/32 (6.25%)  0/0 
Pain in extremity *  2/32 (6.25%)  0/0 
Nervous system disorders     
Balance Disorder *  3/32 (9.38%)  0/0 
Dizziness *  4/32 (12.50%)  0/0 
Dysaesthesia *  2/32 (6.25%)  0/0 
Headache *  23/32 (71.88%)  0/0 
Hypoaesthesia *  4/32 (12.50%)  0/0 
Paraesthesia *  5/32 (15.63%)  0/0 
Psychiatric disorders     
Depression *  2/32 (6.25%)  0/0 
Respiratory, thoracic and mediastinal disorders     
Cough *  4/32 (12.50%)  0/0 
Dyspnoea *  2/32 (6.25%)  0/0 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Merck KGaA Communication Center
Organization: Merck Serono, a division of Merck KGaA
Phone: +49-6151-72-5200
EMail: service@merckgroup.com
Layout table for additonal information
Responsible Party: Merck KGaA, Darmstadt, Germany
ClinicalTrials.gov Identifier: NCT00287079    
Other Study ID Numbers: IMP 26222
First Submitted: February 2, 2006
First Posted: February 6, 2006
Results First Submitted: February 2, 2012
Results First Posted: April 4, 2012
Last Update Posted: December 27, 2013