Multiple SclerosisNCT00202384
Gene Expression in MS Patients Before and During Treatment With Interferon-beta
An observational study of Multiple Sclerosis, run by S. Andrea Hospital at 1 site in Italy.
Trial summary
Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients. Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2004to Jan 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Outpatient MS centres
Who may be able to join
- diagnosis of relapsing-remitting MS (McDonald criteria)
- age between 18-55
- EDSS less or equal to 5.5
Who cannot join
- use of any other disease modifying drugs
- use of corticosteroids during 3 months before starting protocol
- clinical relapse during 1 month before starting protocol
- serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Rome, 00100
About this study
Official title: Gene Expression in MS Patients Before and During Treatment With High-dose Interferon Beta: Prospective Study for the Identification of Predicting Factors of Therapeutic Response.
Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients.
Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time.
The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, microarrays
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Gene Expression in MS Patients
Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment
Measured: baseline and 12 months after IFN beta 1a treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2011
- Study completionJan 2011
Why it stopped: Few participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- S. Andrea Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Ristori, S. Andrea Hospital
- Investigators
- Marco Salvetti, MD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202384
- Sponsor's protocol ID
- NEU - FCG - 02
- Status last verified
- Apr 2018
- First submitted
- 13 Sep 2005
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bomprezzi R, Ringner M, Kim S, Bittner ML, Khan J, Chen Y, Elkahloun A, Yu A, Bielekova B, Meltzer PS, Martin R, McFarland HF, Trent JM. Gene expression profile in multiple sclerosis patients and healthy controls: identifying pathways relevant to disease. Hum Mol Genet. 2003 Sep 1;12(17):2191-9. doi: 10.1093/hmg/ddg221. Epub 2003 Jul 8.
PubMed 12915464Sturzebecher S, Wandinger KP, Rosenwald A, Sathyamoorthy M, Tzou A, Mattar P, Frank JA, Staudt L, Martin R, McFarland HF. Expression profiling identifies responder and non-responder phenotypes to interferon-beta in multiple sclerosis. Brain. 2003 Jun;126(Pt 6):1419-29. doi: 10.1093/brain/awg147.
PubMed 12764062Weinstock-Guttman B, Badgett D, Patrick K, Hartrich L, Santos R, Hall D, Baier M, Feichter J, Ramanathan M. Genomic effects of IFN-beta in multiple sclerosis patients. J Immunol. 2003 Sep 1;171(5):2694-702. doi: 10.4049/jimmunol.171.5.2694.
PubMed 12928423Waubant E, Vukusic S, Gignoux L, Dubief FD, Achiti I, Blanc S, Renoux C, Confavreux C. Clinical characteristics of responders to interferon therapy for relapsing MS. Neurology. 2003 Jul 22;61(2):184-9. doi: 10.1212/01.wnl.0000078888.07196.0b.
PubMed 12874396
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression in MS Patients Before and During Treatment With High-dose Interferon Beta: Prospective Study for the Identification of Predicting Factors of Therapeutic Response.
- ClinicalTrials.gov ID
- NCT00202384
- Acronym / sponsor ID
- NEU - FCG - 02
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, microarrays
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Few participants enrolled
- Enrolment
- 600 participants (actual)
- Lead sponsor
- S. Andrea HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Sep 2005 (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.
Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients.
Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time.
The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatient MS centres
Key inclusion criteria (3 listed)
- diagnosis of relapsing-remitting MS (McDonald criteria)
- age between 18-55
- EDSS less or equal to 5.5
Key exclusion criteria (4 listed)
- use of any other disease modifying drugs
- use of corticosteroids during 3 months before starting protocol
- clinical relapse during 1 month before starting protocol
- serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gene Expression in MS Patients
Time frame: baseline and 12 months after IFN beta 1a treatment
Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment
Results and safety
The study was stopped early (reason given: Few participants enrolled). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
- Background: PubMed 12915464Bomprezzi R, Ringner M, Kim S, Bittner ML, Khan J, Chen Y, Elkahloun A, Yu A, Bielekova B, Meltzer PS, Martin R, McFarland HF, Trent JM. Gene expression profile in multiple sclerosis patients and healthy controls: identifying pathways relevant to disease. Hum Mol Genet. 2003 Sep 1;12(17):2191-9. doi: 10.1093/hmg/ddg221. Epub 2003 Jul 8.
- Background: PubMed 12764062Sturzebecher S, Wandinger KP, Rosenwald A, Sathyamoorthy M, Tzou A, Mattar P, Frank JA, Staudt L, Martin R, McFarland HF. Expression profiling identifies responder and non-responder phenotypes to interferon-beta in multiple sclerosis. Brain. 2003 Jun;126(Pt 6):1419-29. doi: 10.1093/brain/awg147.
- Background: PubMed 12928423Weinstock-Guttman B, Badgett D, Patrick K, Hartrich L, Santos R, Hall D, Baier M, Feichter J, Ramanathan M. Genomic effects of IFN-beta in multiple sclerosis patients. J Immunol. 2003 Sep 1;171(5):2694-702. doi: 10.4049/jimmunol.171.5.2694.
- Background: PubMed 12874396Waubant E, Vukusic S, Gignoux L, Dubief FD, Achiti I, Blanc S, Renoux C, Confavreux C. Clinical characteristics of responders to interferon therapy for relapsing MS. Neurology. 2003 Jul 22;61(2):184-9. doi: 10.1212/01.wnl.0000078888.07196.0b.
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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.
Marco Salvetti, MD study director
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 S. Andrea Hospital at 1 site in Italy.
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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Apr 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 Italy. 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 was stopped early (reason given: Few participants enrolled). Results are not available in the source record.
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?
Gene Expression in MS Patients (time frame: baseline and 12 months after IFN beta 1a treatment). 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 NCT00202384, which also lists 4 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 19 Apr 2018; AzTrials last refreshed its copy on 6 Nov 2026.