Gene Expression in MS Patients Before and During Treatment With Interferon-beta

NCT ID: NCT00202384

Last Updated: 2018-04-19

Study Results

Results pending

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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Recruitment Status

TERMINATED

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-11-30

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of relapsing-remitting MS (McDonald criteria)
* age between 18-55
* EDSS less or equal to 5.5

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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S. Andrea Hospital

OTHER

Sponsor Role lead

Responsible Party

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Giovanni Ristori

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Italy

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.

Reference Type BACKGROUND
PMID: 12915464 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12764062 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12928423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12874396 (View on PubMed)

Other Identifiers

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NEU - FCG - 02

Identifier Type: -

Identifier Source: org_study_id

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