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

Multiple Sclerosis Clinical Trial

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 Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00202384
• Other study ID #: NEU - FCG - 02
• Status: Terminated
• First received: September 13, 2005
• Last updated: April 17, 2018
• Start date: November 2004
• Est. completion date: January 2011

Study information

• Verified date: April 2018
• Source: S. Andrea Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 600
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"	Rome

Sponsors (1)

Lead Sponsor	Collaborator
S. Andrea Hospital

Country where clinical trial is conducted

Italy, 

References & Publications (4)

Bomprezzi R, Ringnér 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. — View Citation

Stürzebecher 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gene Expression in MS Patients	Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment	baseline and 12 months after IFN beta 1a treatment