Gene Expression in MS Patients Before and During Treatment With Interferon-beta
NCT ID: NCT00202384
Last Updated: 2018-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
600 participants
OBSERVATIONAL
2004-11-30
2011-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* age between 18-55
* EDSS less or equal to 5.5
Exclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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S. Andrea Hospital
OTHER
Responsible Party
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Giovanni Ristori
MD
Principal Investigators
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Marco Salvetti, MD
Role: STUDY_DIRECTOR
Locations
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Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
Rome, , Italy
Countries
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References
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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.
Sturzebecher 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.
Weinstock-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.
Waubant 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.
Other Identifiers
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NEU - FCG - 02
Identifier Type: -
Identifier Source: org_study_id
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