Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis
Conditions
Interventions
Trade Name: Tysabri
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Natalizumab
Current Sponsor code: BG00002
Concentration unit: mg milligram(s)
Concentration type: eq
Sponsors
Biogen Idec International GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must give written informed consent and provide all authorizations required by local law (e.g., Protected Health Information [PHI]) 2. Men or women between 18 and 60 years of age, inclusive 3. Must have EDSS = 5.5 at baseline. 4. Must be able to walk at least 100m without assistive devices 5. Must be natalizumab naïve 6. Must have a documented diagnosis of a relapsing remitting form of MS as defined by the revised McDonald Committee criteria (Polman, 2005) 7. Must have had a recent MRI (within 3 months from baseline) 8. Must have had at least 1 relapse in the previous year and must satisfy the locally approved therapeutic indications for TYSABRI®. If TYSABRI® is not yet approved in a specific country, patients must fulfill the following criteria: • Patients with high disease activity despite treatment with a beta-interferon defined as patients who have failed to respond to a full and adequate course of a beta-interferon. Patients must 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 Gd-enhancing lesion. Or • Patients with rapidly evolving severe relapsing remitting multiple sclerosis defined as patients who have had 2 or more disabling relapses in one year and 1 or more Gd-enhancing lesions on brain MRI or significant increase in T2 lesions as compared to a previous MRI 9. Must be stable in disability for at least 30 days prior to enrollment to the study 10. Must be stable in symptomatic management of the disease, specifically spasticity, depression and fatigue for at least 30 days prior to enrollment to the study 11. Must be considered by the Investigator to be free of signs and symptoms suggestive of PML based on medical history, physical examination, or laboratory testing. 12. Must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN beta and GA) while being treated with natalizumab during the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Medical History: 1. Onset of a relapse within 50 days prior to first infusion 2. Considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing or due to prior immunosuppressive treatment 3. History of, or available abnormal laboratory results indicative of, any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric (including major depression), renal, and/or other major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent. The Investigator must re-review the subject’s medical fitness for participation and consider any diseases that would preclude treatment. 4. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible) 5. Known history of human immunodeficiency virus infection or hematological malignancy 6. History of organ transplantation (including anti-rejection therapy) 7. A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit. Treatment History: 8. Treatment with immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 6 months prior to Screening Miscellaneous 9. Female subjects who are not postmenopausal for at least 1 year, surgically sterile (does not include tubal ligation), or willing to practice effective contraception (as defined by the Investigator) during the study 10. Women who are breastfeeding, pregnant, or planning to become pregnant while on study 11. Current enrollment in any other study treatment or disease study 12. Unwillingness or inability to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol 13. Subjects with walking impairment due to causes other than MS 14. Other unspecified reasons that, in the opinion of the Investigator and/or Biogen Idec, make the subject unsuitable for enrollment into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the evolution of walking capacity as measured by T100T, T25FW, MWD and EDSS during the first year of therapy with natalizumab;Secondary Objective: To evaluate the correlation between the MWD and EDSS and both walking tests, the T100T and the T25FW at baseline, at 6 months and at 1 year of therapy. To determine how well each of the walking tests, T100T or T25FW, predicts walking limitations in all subjects and in the subgroups of subjects stratified by baseline EDSS. ;Primary end point(s): The primary endpoint of the study is the evolution of walking abilities as measured by MWD, EDSS, T25FW and T100T during the first year of therapy with natalizumab. | — |
Countries
Belgium
Outcome results
None listed