Multiple SclerosisNCT00468182
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Interferon-beta 1b (Betaseron)
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Multiple Sclerosis Clinic patient
Who may be able to join
- Males and females, 18 to 60 year old, inclusive.
- Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
- Expanded disability status scale (EDSS) score less than 6 at entry.
- Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
Who cannot join
- Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
- No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
- Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
- History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
- Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Being tested
- Interferon-beta 1b (Betaseron)
- Keywords
- Multiple sclerosis, Interferon beta, plasmacytoid dendritic cells
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-beta 1b (Betaseron)Drug
Treatment of patients with FDA-approved Rx
| Study group | Role | What they receive |
|---|---|---|
| 1 | MS patients or patients with CIS (Clinically isolated syndrome) who decided to be treated with IFN-beta for 3 months (with the option to continue Rx) Receives: Drug: Interferon-beta 1b (Betaseron) | |
| 2 | MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative gene expression in plasmacytoid dendritic cells (pDCs)
Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks
Measured: Change in gene expression in 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Konstantin Balashov, Rutgers, The State University of New Jersey
- Investigators
- Konstantin Balashov, M.D., Ph.D., Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00468182
- Sponsor's protocol ID
- 0220060228
- Status last verified
- May 2015
- First submitted
- 30 Apr 2007
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Aung LL, Brooks A, Greenberg SA, Rosenberg ML, Dhib-Jalbut S, Balashov KE. Multiple sclerosis-linked and interferon-beta-regulated gene expression in plasmacytoid dendritic cells. J Neuroimmunol. 2012 Sep 15;250(1-2):99-105. doi: 10.1016/j.jneuroim.2012.05.013. Epub 2012 Jun 9.
PubMed 22688425Balashov KE, Aung LL, Vaknin-Dembinsky A, Dhib-Jalbut S, Weiner HL. Interferon-beta inhibits toll-like receptor 9 processing in multiple sclerosis. Ann Neurol. 2010 Dec;68(6):899-906. doi: 10.1002/ana.22136.
PubMed 21061396Aung LL, Fitzgerald-Bocarsly P, Dhib-Jalbut S, Balashov K. Plasmacytoid dendritic cells in multiple sclerosis: chemokine and chemokine receptor modulation by interferon-beta. J Neuroimmunol. 2010 Sep 14;226(1-2):158-64. doi: 10.1016/j.jneuroim.2010.06.008.
PubMed 20621365
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00468182
- Acronym / sponsor ID
- 0220060228
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, Interferon beta, plasmacytoid dendritic cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Apr 2007
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 May 2007 (estimated)
- Results
- Not posted in the source record
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 study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Interferon-beta 1b (Betaseron)MS patients or patients with CIS (Clinically isolated syndrome) who decided to be treated with IFN-beta for 3 months (with the option to continue Rx) |
| 2 | – | –MS patients or patients with CIS(Clinically isolated syndrome)who decided to postpone the treatment with IFN-beta |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Multiple Sclerosis Clinic patient
Key inclusion criteria (4 listed)
- Males and females, 18 to 60 year old, inclusive.
- Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
- Expanded disability status scale (EDSS) score less than 6 at entry.
- Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
Key exclusion criteria (5 listed)
- Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
- No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
- Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
- History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
- Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years
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 |
|---|---|---|
| Interferon-beta 1b (Betaseron)Treatment of patients with FDA-approved Rx | Drug | 1 |
Primary outcome
Relative gene expression in plasmacytoid dendritic cells (pDCs)
Time frame: Change in gene expression in 12 weeks
Gene expression is tested in pDCs separetd from peripheral blood of human subjects at baseline and at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
- Background: PubMed 22688425Aung LL, Brooks A, Greenberg SA, Rosenberg ML, Dhib-Jalbut S, Balashov KE. Multiple sclerosis-linked and interferon-beta-regulated gene expression in plasmacytoid dendritic cells. J Neuroimmunol. 2012 Sep 15;250(1-2):99-105. doi: 10.1016/j.jneuroim.2012.05.013. Epub 2012 Jun 9.
- Results publication: PubMed 21061396Balashov KE, Aung LL, Vaknin-Dembinsky A, Dhib-Jalbut S, Weiner HL. Interferon-beta inhibits toll-like receptor 9 processing in multiple sclerosis. Ann Neurol. 2010 Dec;68(6):899-906. doi: 10.1002/ana.22136.
- Results publication: PubMed 20621365Aung LL, Fitzgerald-Bocarsly P, Dhib-Jalbut S, Balashov K. Plasmacytoid dendritic cells in multiple sclerosis: chemokine and chemokine receptor modulation by interferon-beta. J Neuroimmunol. 2010 Sep 14;226(1-2):158-64. doi: 10.1016/j.jneuroim.2010.06.008.
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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.
Konstantin Balashov, M.D., Ph.D. principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Rutgers, The State University of New Jersey 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 4 inclusion and 5 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 7 May 2015. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative gene expression in plasmacytoid dendritic cells (pDCs) (time frame: Change in gene expression in 12 weeks). 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 NCT00468182, which also lists 3 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 7 May 2015.