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

NCT00202384 | Terminated DMC

• 1 other identifier: NEU - FCG - 02
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; microarrays

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Outpatient MS centres

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• S. Andrea Hospital: lead

Study Sites (1)

Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"

Rome, 00100, Italy

Location

Related Publications (4)

• 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.

  PMID: 12915464 BACKGROUND

• 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.

  PMID: 12764062 BACKGROUND

• 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.

  PMID: 12928423 BACKGROUND

• 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.

  PMID: 12874396 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marco Salvetti, MD

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: November 1, 2004
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 19, 2018

Record last verified: 2018-04

Locations

IT (1)