Clinically Isolated SyndromePhase 3CIS-ONNCT00287079

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

A Phase 3 study testing Rebif® and No Treatment in people with Clinically Isolated Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 months to 65 years
Conditions the study is for: Clinically Isolated Syndrome
What is being tested?: Rebif® and No Treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteCanada
Study dates: Oct 2005to Nov 2008
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 months to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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:

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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

Who cannot join

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:

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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

Trial locations and contacts

1 site in 1 country.

Canada1 site

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

Other trials in Canada

About this study

Official title: A Prospective, Open Label, Multi-centre Study Exploring the Use of Subcutaneous (sc) 44 Microgram Interferon (IFN) Beta - 1a (Rebif®) Once a Week (qw) in Subjects With Clinically Isolated Syndrome (CIS)

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: Clinically Isolated Syndrome
Being tested: Rebif®, No Treatment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rebif®Drug
44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks
No TreatmentOther
No treatment for 96 weeks

Study groups in NCT00287079
Study group	Role	What they receive
Rebif®	Experimental	Not described Receives: Drug: Rebif®
No Treatment	Other	Not described Receives: Other: No Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to Week 96

Secondary outcomes (2)

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.
Measured: 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.
Measured: Up to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2005Nov 2008

First posted6 Feb 2006 (estimated)
Study startOct 2005
Primary completionNov 2008
Study completionNov 2008

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.
Other trials for Clinically Isolated SyndromeStudies 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
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00287079
Sponsor's protocol ID: IMP 26222
Acronym: CIS-ON
Status last verified: Dec 2013
First submitted: 2 Feb 2006
Last updated: 27 Dec 2013
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Clinically Isolated Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Open Label, Multi-centre Study Exploring the Use of Subcutaneous (sc) 44 Microgram Interferon (IFN) Beta - 1a (Rebif®) Once a Week (qw) in Subjects With Clinically Isolated Syndrome (CIS)
ClinicalTrials.gov ID: NCT00287079
Acronym / sponsor ID: CIS-ON / IMP 26222
Conditions: Clinically Isolated Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
Collaborators: EMD Serono Canada Inc.
Study start: Oct 2005
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 6 Feb 2006 (estimated)
Results: Posted 4 Apr 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Rebif®	Experimental	Drug: Rebif®
No Treatment	Other	Other: No Treatment

Who may qualify

Ages: 18 months to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (9 listed)

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

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®44 microgram (mcg) IFN beta-1a sc once a week (qw) for 96 weeks	Drug	Rebif®
No TreatmentNo treatment for 96 weeks	Other	No Treatment

Primary outcome

Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates
Time frame: Up to Week 96
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.

2 secondary outcomes

Percentage of Participants Who Converted to Clinical Definite Multiple Sclerosis (CDMS)
Time frame: Up to Week 96
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Up to Week 96

Results and safety

Results posted to the registry on 4 Apr 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rebif 44 Mcg	32	10
No Treatment	3	2

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

Time frame: Up to Week 96. Mean (Standard Error). Unit: Month

Measure	Rebif 44 Mcg n = 30	No Treatment n = 3
Value	15.6 (1.23)	17.0 (NA)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 96. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rebif 44 Mcg	1 of 32 (3.1%)	32 of 32 (100%)	Not reported
No Treatment	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Full FDA approved prescribing information can be found hereLink provided by the sponsor.

Related trials for Clinically Isolated Syndrome

Active, not recruitingObservational study
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Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
Multiple Sclerosis, Clinically Isolated Syndrome
Not yet recruitingObservational study
Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care
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Active, not recruiting
Autoimmune Intervention Mastery Course Study
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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.

Medical Director study director

EMD Serono Canada Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rebif® and No Treatment in people with Clinically Isolated Syndrome, run by Merck KGaA, Darmstadt, Germany at 1 site in Canada.

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 10 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 27 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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 4 Apr 2012). 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?

Time in Month to Clinical Definite Multiple Sclerosis (CDMS) From Kaplan-Meier Estimates (time frame: Up to Week 96). 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 NCT00287079.

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 27 Dec 2013.