Gene Expression in MS Patients Before and During Treatment With Interferon-Beta - Full Text View

Sponsored by:	S. Andrea Hospital
Information provided by:	S. Andrea Hospital
ClinicalTrials.gov Identifier:	NCT00202384

Purpose

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.

Condition	Phase
Multiple Sclerosis	Phase IV

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Interferons Interferon beta Interferon-beta

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Case Control, Prospective 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.

Further study details as provided by S. Andrea Hospital:

Estimated Enrollment:	600
Study Start Date:	November 2004

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202384

Contacts

Contact: Marco Salvetti, MD

+390680345994

marco.salvetti@uniroma1.it

Locations

Italy
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"	Recruiting
Rome, Italy, 00100
Sub-Investigator: Lorenzo Figà Talamanca, MD

Sponsors and Collaborators

S. Andrea Hospital

Investigators

Study Director:

Marco Salvetti, MD

Unaffiliated

More Information

Neurological Centers for Experimental Therapy-a center specialised in the trial of new therapies in neurological disease belonging to the Neurology Complex Operational Unit of the S. Andrea Hospital This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

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. 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.

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.

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. Review.

Study ID Numbers:	NEU - FCG - 02
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00202384
Health Authority:	Italy: Ministry of Health

Keywords provided by S. Andrea Hospital:

Multiple Sclerosis
microarrays

Study placed in the following topic categories:

Autoimmune Diseases
Multiple Sclerosis
Demyelinating Diseases
Interferons
Interferon-beta

Demyelinating Autoimmune Diseases, CNS
Demyelinating diseases
Sclerosis
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Immunologic Factors
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Nervous System Diseases
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009