Biomarkers and Response to Natalizumab for Multiple Sclerosis Treatment

NCT00942214 | Completed Phase 4

• 1 other identifier: 0811001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Information from blood samples may help us for choosing the best treatment in future personalized medicine. Natalizumab (NTZ) a current treatment for MS can be used as a second line therapy if a suboptimal response to disease modifying drugs. When to introduce NTZ is not consensual. The investigators hypothesized that biological information could rationalize choice and thus designed a prospective open label trial to test biological markers before treatment.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; natalizumab; pharmacogenomics

Outcome Measures

Primary Outcomes (1)

• haplotypic frequency difference between responders and non-responders

  12 and 24 months

Interventions

Natalizumab DRUG

300mg, IV, every 4 weeks

Also known as: Tysabry (brand name)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients between the ages of 18 and 55 years.
• Diagnosis of relapsing multiple sclerosis according to McDonald criteria.
• EDSS score of 0 to 5.0 on the EDSS scale. One of the following 2 items:
• Patients who have failed to respond to a full and adequate course of a beta-interferon. Patients have had at least 1 relapse in the previous year while on therapy, and have at least 9 T2-hyperintense lesions in cranial MRI or at least 1 Gadolinium-enhancing lesion.
• Patients with rapidly evolving severe relapsing remitting multiple sclerosis, defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.

You may not qualify if:

• Hypersensitivity to natalizumab or to any of the excipients.
• Progressive Multifocal Leukoencephalopathy (PML).
• Increased risk of opportunistic infections, including immunocompromised patients (including those currently receiving immunosuppressive therapies or those immunocompromised by prior therapies, e.g. mitoxantrone or cyclophosphamide within 1 year before Tysabri.
• Combination with beta-interferons or glatiramer acetate.
• Known active malignancies, except for patients with cutaneous basal cell carcinoma.
• Children and adolescents.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

service de neurologie, hôpital Purpan

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• David Brassat, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 16, 2009
• First Posted: July 20, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 30, 2011

Record last verified: 2011-03

Locations

FR (1)