Multiple SclerosisPhase 4NCT01085318
Rebif Advanced Magnetic Resonance Imaging (MRI) and Immunology Pilot Trial
A Phase 4 study testing Rebif in people with Multiple Sclerosis, run by EMD Serono at 1 site in United States.
Trial summary
The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central nervous system (CNS) iron deposition, and d) immune status in subjects with relapsing-remitting multiple sclerosis (RRMS) RRMS via… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Rebif
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2010to 31 Mar 2012
- Phase
- Phase 4
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
- RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or Rebif®)
- Have a disease duration of up to twenty years
- Be willing and able to comply with the study procedures for the duration of the trial
- Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:
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- The following inclusion criteria must be fulfilled by the Healthy Control subjects:
- Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
- Be willing and able to comply with the study procedures for the duration of the trial
- Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
- Female subjects must not be either pregnant or breast-feeding and must lack childbearing potential, as defined by either:
Who cannot join
- Have received treatment within three months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
- Have received treatment within thirty days prior to screening with immunosuppressant agents (e.g. including but not limited to mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation) or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate, CellCept®, natalizumab, alemtuzumab/Campath and other immunomodulators/monoclonal agents)
- Have had a relapse within thirty days prior to the Screening Visit
- Have received steroid treatment within thirty days prior to the initial MRI scan date at Study Day 1
- Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 1.5x ULN
- Have inadequate bone marrow reserve, defined as a total white blood cell count < 3.0x 109/L, platelet count < 75x109/L, hemoglobin < 100g/L
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- Have complete transverse myelitis or simultaneous-onset bilateral optic neuritis
- Have a history of alcohol or drug abuse
- Have thyroid dysfunction
- Have moderate to severe renal impairment
- Have a major medical or psychiatric illness that in the opinion of the investigator creates undue risk to the subject or could affect compliance with the study protocol
- Have a history of seizures not adequately controlled by treatment
- Have serious or acute cardiac disease, such as uncontrolled dysrhythmias, uncontrolled angina pectoris, cardiomyopathy, or uncontrolled congestive heart failure
- Have, in the opinion of the investigator, any visual, physical or cognitive impairment that would preclude the subject from complying with the study protocol
- Have a known hypersensitivity or allergy to interferon-beta or any of the excipients
- Have received an investigational drug or experimental procedure within the past thirty days
- Are pregnant or attempting to conceive
- The following exclusion criteria must be fulfilled by the Healthy Control subjects:
- 1. Have met any of the above noted criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif® 44 mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control Group
The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central nervous system (CNS) iron deposition, and d) immune status in subjects with relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.
- Conditions
- Multiple Sclerosis
- Being tested
- Rebif
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RebifDrug
44 mcg tiw
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 MS Patients | Active comparator | Rebif 44 tiw Receives: Drug: Rebif |
| Arm 2 Healthy Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months
To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).
Measured: Baseline to Month 6
Secondary outcomes (1)
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months
To characterize the effect of Rebif on demyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).
Measured: Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study start30 Jun 2010
- Primary completion29 Feb 2012
- Study completion31 Mar 2012
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies 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 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fernando Dangond, MD, Study director, EMD Serono
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085318
- Sponsor's protocol ID
- 29665
- Status last verified
- Jan 2018
- First submitted
- 10 Mar 2010
- Last updated
- 23 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, Hayward B, Dangond F, Markovic-Plese S. Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial. BMC Neurol. 2015 Nov 11;15:232. doi: 10.1186/s12883-015-0488-9.
PubMed 26559139Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, Weinstock-Guttman B. Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study. PLoS One. 2014 Mar 13;9(3):e91098. doi: 10.1371/journal.pone.0091098. eCollection 2014.
PubMed 24625687
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twenty-four Week, Two Arm, Pilot Trial to Evaluate Remyelination/ Demyelination, Gray Matter Volume and Iron Deposition in the Central Nervous System (CNS) and Immune Status of Subjects With Relapsing-remitting Multiple Sclerosis (RRMS) Treated With Rebif® 44 mcg Subcutaneously (sc) Three Times a Week (Tiw) Compared to a Healthy Control Group
- ClinicalTrials.gov ID
- NCT01085318
- Acronym / sponsor ID
- 29665
- Conditions
- Multiple Sclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2010 (actual)
- Primary completion
- 29 Feb 2012 (actual)
- Study completion
- 31 Mar 2012 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Posted 3 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the effects of Rebif® 44 mcg subcutaneous (sc) three times a week (tiw) on a) remyelination/demyelination, b) lesion and brain volume, c) central nervous system (CNS) iron deposition, and d) immune status in subjects with relapsing-remitting multiple sclerosis (RRMS) RRMS via several MRI techniques.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 MS Patients | Active comparator | Drug: RebifRebif 44 tiw |
| Arm 2 Healthy Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects, 18-65 years of age, inclusive, at the time of informed consent signature
- RRMS diagnosed according to the McDonald criteria, treatment naïve or currently using any of the FDA-approved DMDs (excluding natalizumab (Tysabri®), mitoxantrone or Rebif®)
- Have a disease duration of up to twenty years
- Be willing and able to comply with the study procedures for the duration of the trial
- Have given written informed consent and signed Health Insurance Portability and Accountability Act (HIPAA) Authorization before any study- related activities are carried out
Key exclusion criteria (19 listed)
- Have received treatment within three months prior to Screening with interferon-beta-1a (Rebif®), IVIG or plasmapheresis
- Have received treatment within thirty days prior to screening with immunosuppressant agents (e.g. including but not limited to mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine or total body irradiation) or any other concomitant immunomodulatory therapies (e.g., azathioprine, methotrexate, CellCept®, natalizumab, alemtuzumab/Campath and other immunomodulators/monoclonal agents)
- Have had a relapse within thirty days prior to the Screening Visit
- Have received steroid treatment within thirty days prior to the initial MRI scan date at Study Day 1
- Have inadequate liver function, defined by a alanine aminotransferase (ALT) > 2.5x upper limit of normal (ULN), or alkaline phosphatase > 2.5x ULN, or total bilirubin > 1.5x ULN
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 |
|---|---|---|
| Rebif44 mcg tiw | Drug | Arm 1 MS Patients |
Primary outcome
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months
Time frame: Baseline to Month 6
To characterize the effect of Rebif on remyelination using VW-MTR dynamic mapping of NABT in subjects ith RRMS over 6 months of treatment compared to a group of healthy Control (HC).
1 secondary outcome
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Decreasing (Indicative of Demyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR)From Baseline to 6 Months
Time frame: Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26559139Dwyer MG, Zivadinov R, Tao Y, Zhang X, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Weinstock-Guttman B, Hayward B, Dangond F, Markovic-Plese S. Immunological and short-term brain volume changes in relapsing forms of multiple sclerosis treated with interferon beta-1a subcutaneously three times weekly: an open-label two-arm trial. BMC Neurol. 2015 Nov 11;15:232. doi: 10.1186/s12883-015-0488-9.
- Results publication: PubMed 24625687Zivadinov R, Dwyer MG, Markovic-Plese S, Kennedy C, Bergsland N, Ramasamy DP, Durfee J, Hojnacki D, Hayward B, Dangond F, Weinstock-Guttman B. Effect of treatment with interferon beta-1a on changes in voxel-wise magnetization transfer ratio in normal appearing brain tissue and lesions of patients with relapsing-remitting multiple sclerosis: a 24-week, controlled pilot study. PLoS One. 2014 Mar 13;9(3):e91098. doi: 10.1371/journal.pone.0091098. eCollection 2014.
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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.
Fernando Dangond, MD study director
EMD Serono
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rebif in people with Multiple Sclerosis, run by EMD Serono at 1 site in United States.
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 11 inclusion and 19 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 23 Feb 2018. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 3 May 2013). 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?
Change in Volume (in Millimeters Cubed) of Normal Appearing Brain Tissue (NABT) With Increasing (Indicative of Remyelination) Voxel-wise Magnetization Transfer Ratio (VW-MTR) From Baseline to 6 Months (time frame: Baseline to Month 6). 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 NCT01085318, which also lists 2 linked publications.
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 23 Feb 2018.