Multiple sclerosis (MS) MedDRA version: 14.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: TYSABRI 300 mg concentrate for solution for infusion
Product Name: NATALIZUMAB
Product Code: BG00002
Pharmaceutical Form: Concentrate for so
Sponsors
BIOGEN IDEC LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) must give informed consent and provide all athorizations required by local law 2) must be an MS subject who completed Study C-1801 or C-1802 and completed a Dosing Suspension Safety Evaluation (neurological examination or an MRI scan), or participated in Study IMA 04001 (STARS) or completed 48 weeks of treatment in Study 101-MS-322 in Canada. These subjects will be allowed to enter this study at the start of the Long-Term Treatment period (Week 52) 3) 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 4) must be willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFNb and GA) for the duration of the study. NOTE: Subjects who were found to be on placebo after being unblinded for a serious adverse event (SAE) in Study C-1801 or C-1802 are eligible to enroll in this study if they completed a Dosing Suspension Safety Evaluation, receive approval from the Biogen Idec Medical Director or the relevant Advisory Committee, meet all other inclusion criteria for this study, and are not excluded based on the exclusion criteria for this 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 458 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) considered by the Investigator to be immunocompromised, based on medical history, physical examination, or laboratory testing (results from the Dosing Suspension Safety Evaluation from Study C-1808 may be used), or due to prior immunosuppressive treatment 2) history of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies 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 for 48 weeks. 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) history of severe allergic or anaphylactic reactions or known drug hypersensitivity 8) a significant change (as determined by the Investigator) in the subject’s medical history from their previous natalizumab study 9) a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to the Screening Visit in Study 101-MS-321 Treatment History 10) discontinued natalizumab in a previous study due to allergic reaction or any other SAE considered to be related to natalizumab treatment 11) discontinued study drug in Study C-1801 or C-1802 because of an AE or due to reasons other than significant disease progression (as defined in the C 1801 and C 1802 protocols) 12) treatment with immunosuppressant medications (e.g., mitoxantrone, cyclophosphamide, cyclosporine, azathioprine, methotrexate) within 3 months prior to Screening Miscellaneous 13) 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 14) women who are breastfeeding, pregnant, or planning to become pregnant while on study 15) current enrollment in any other study treatment or disease study 16) 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 17) 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: Initial Treatment Period: To further evaluate the safety of natalizumab monotherapy by: 1) evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab and 2) confirming the safety of switching from interferon beta (IFNb), glatiramer acetate (GA), or other MS therapies to natalizumab. Long-Term Treatment Period: To evaluate the long-term impact of natalizumab monotherapy on the progression of disability measured by EDSS changes over time. ;Secondary Objective: Not available; Primary end point(s): Initial Treatment Period: To further evaluate the safety of natalizumab monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab and, confirming the safety of switching from IFNb, GA or other MS therapies to natalizumab. The safety endpoint under consideration will be the incidence of AEs. The incidence of development of antibodies to natalizumab will also be assessed. Long-Term Treatment Period: To evaluate the long term impact of natalizumab monotherapy on the progression of disability measured by EDSS changes over time. ;Timepoint(s) of evaluation of this end point: Every 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not available;Timepoint(s) of evaluation of this end point: Not available | — |
Countries
Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, New Zealand, Poland, Spain, Sweden, Switzerland, Turkey, United Kingdom
Contacts
Public ContactClinical Trial Information Desk
Biogen Idec Limited
Outcome results
None listed