CompletedNCT00287079CIS-ONUpdated Dec 27, 2013Results posted

A Prospective Study Looking at the Use of Rebif® in Subjects With Clinically Isolated Syndrome

A Phase 3 interventional study of Rebif® and No Treatment in Clinically Isolated Syndrome, sponsored by Merck KGaA, Darmstadt, Germany. Completed at 1 site in Canada. Open to participants aged 18 Months to 65 Years. Per ClinicalTrials.gov, last updated 2013-12-27.

Sponsored by Merck KGaA, Darmstadt, Germany · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 35
Ages: 18 Months to 65 Years
Sex: All

Study summary

The primary objective of this initiative is to assess the effectiveness of subcutaneous (sc) interferon (IFN) beta - 1a, (Rebif®), versus No Treatment in delaying the conversion to Clinically Definite Multiple Sclerosis (CDMS) - as defined by the occurrence of a second exacerbation - over 96 weeks in subjects that present with Clinically Isolated Syndrome (CIS) accompanied by an abnormal magnetic resonance imaging (MRI). The secondary objectives are to:

Assess the effectiveness of sc IFN beta - 1a (Rebif®) therapy in reducing the proportion of patients with CIS converting to CDMS
Assess the safety of sc IFN beta - 1a (Rebif®) in the patients with CIS

Conditions studied

Clinically Isolated Syndrome

Browse trials for

Syndrome 9,217

In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 35 is below the median of 50 across 6,515 interventional studies indexed under Syndrome.

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Lead sponsor

Merck KGaA, Darmstadt, Germany is the lead sponsor of 269 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Months to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject must have experienced a first clinical episode suggestive of demyelinating disease
Subject must present with an abnormal MRI displaying at least 3 T2 weighted hyperintense lesions typical of multiple sclerosis (MS)
Subject must be greater than or equal to 18 years old
Subject must have had onset of the clinical attack within the last 120 days
Subject must give written informed consent
Female subjects must be neither pregnant nor breast feeding, and must not be of child-bearing potential as defined by either:
Being post-menopausal or surgically sterile
Using hormonal contraceptive, intra-uterine device, diaphragm with spermicide or condom with spermicide for the duration of the study

Subjects electing treatment:

Subject must be eligible for Interferon-beta 1-a therapy

Exclusion criteria

Exclusion Criteria:

Subject has evidence of other neurological diseases that could explain his/her symptomatology
Subject is pregnant or in lactation
Subject suffers from an intercurrent autoimmune disease
Subject suffers from major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the procedures required by this study
Subject has received immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporine, methotrexate, azathioprine, linomide, mitoxantrone, teriflunomide, natalizumab, laquinimod, campath), within 12 months of study day 1

Subjects electing treatment:

Subject has inadequate liver function, defined by total bilirubin, aspartate transaminase (AST), alanine aminotransferase (ALT), or alkaline phosphatase > 2.5 times the upper limit of normal values
Subject has inadequate bone marrow reserve, defined as white blood cell count less than 0.5 times the lower limit of normal
Subject has a known allergy to IFN or any of the excipients of the drug product

Study design

Phase: Phase 3
Primary purpose: Treatment
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 35 participants (actual)

Study arms

Experimental
Rebif®
Drug: Rebif®
Other
No Treatment
Other: No Treatment

Interventions

DrugRebif®
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
OtherNo Treatment
No treatment for 96 weeks

What researchers measure

Primary outcomes

Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
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

Secondary outcomes

Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
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
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
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

Results

Posted Apr 4, 2012

Participant flow

Participant flow — Overall Study
Milestone	Rebif 44 Mcg	No Treatment
Started	32	3
Completed	10	2
Not completed	22	1
Withdrew: Qualifying relapse	12	1
Withdrew: Non-qualifying relapse	1	0
Withdrew: Adverse event	5	0
Withdrew: Protocol violation	1	0
Withdrew: Other	3	0

Outcome measures

SecondaryPercentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)

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
Reported as:: Number · Percentage of participants

Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
Percentage of participants	Rebif 44 Mcg	No Treatment
Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)	37.5	33.3

SecondaryPercentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)

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
Reported as:: Number · percentage of participants

Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
percentage of participants	Rebif 44 Mcg	No Treatment
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)	100	—

PrimaryTime in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates

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
Reported as:: Mean · Month

Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
Month	Rebif 44 Mcg	No Treatment
Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates	15.6 ± 1.23	17.0 ± NA

Adverse events

Collected over Up to Week 96. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Rebif 44 Mcg	—	1/32 (3.1%)	32/32 (100%)
No Treatment	—	—	—

Most frequent serious events

Most frequent serious events
Event	Rebif 44 Mcg	No Treatment
Mild LeucopeniaBlood and lymphatic system disorders	1/32	—

Most frequent other events

Showing 10 of 31

Most frequent other events
Event	Rebif 44 Mcg	No Treatment
HeadacheNervous system disorders	23/32	—
FatigueGeneral disorders	17/32	—
ChillsGeneral disorders	16/32	—
PainGeneral disorders	12/32	—
NauseaGastrointestinal disorders	10/32	—
NasopharyngitisInfections and infestations	9/32	—
Influenza like illnessGeneral disorders	7/32	—
Injection site erythemaGeneral disorders	5/32	—
ParaesthesiaNervous system disorders	5/32	—
Injection site irritationGeneral disorders	4/32	—

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Rebif 44 Mcg	No Treatment	Total
Mean	36.30 ± 9.68	35.30 ± 13.32	35.80 ± 11.50

Sex: Female, Male
Sex: Female, Male(Participants)	Rebif 44 Mcg	No Treatment	Total
Female	19	3	22
Male	13	0	13

Study locations

1 site

Canadian Medical Information Office
Windsor, Barrie, Hamilton, Mississauga, Ontario, Canada

References and documents

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 27, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00287079
Lead sponsor: Merck KGaA, Darmstadt, Germany
Collaborators: EMD Serono Canada Inc.
Responsible party: Sponsor
First posted: Feb 6, 2006
Start date: Oct 2005
Primary completion: Nov 2008
Completion: Nov 2008
Results posted: Apr 4, 2012
Last update: Dec 27, 2013

Study contacts

Medical Director

study director · EMD Serono Canada Inc.

View the source record on ClinicalTrials.gov ↗

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