Randomized Treatment Interruption of Natalizumab - RESTORE

Conditions: atalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months.
MedDRA version: 12.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

Registration Number: EUCTR2009-017490-38-DE

Lead Sponsor: Biogen Idec

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 200

Inclusion Criteria

1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Aged 18 to 60 years old, inclusive, at the time of informed consent.
3. Subjects of childbearing potential must practice effective contraception during the study.
4. A diagnosis of a relapsing form of MS consistent with local approved prescribing
information.
5. Treatment with natalizumab according to locally approved prescribing information for a minimum of the 12 months immediately prior to randomization. The subject must have received at least 11 doses of natalizumab in the 12 months prior to randomization with no missed doses in the 3 months prior to randomization.
6. No MS relapses within the 12 months prior to randomization.
7. Must be considered by the Investigator to be free of signs and symptoms suggestive of any serious infection, based on medical history, physical examination, or laboratory testing.
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

1. Known history of Human Immunodeficiency Virus (HIV).
2. Known history of hepatitis C (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for Hepatitis B Surface Antigen [HBsAg] and/or Hepatitis B Core Antibody [HBcAb]).
3. Positive for anti-natalizumab antibodies at Screening.
4. Any evidence of Gd-enhancement at Screening.
5. Subjects for whom MRI is contraindicated, i.e., have pacemakers or other contraindicated implanted metal devices, have suffered, or are at risk for, side effects from Gd, or have claustrophobia that cannot be medically managed.
6. History of any clinically significant (as determined by the Investigator) cardiac,
endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes),
urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study.
7. History of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
8. History of transplantation or any anti-rejection therapy.
9. History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug.
10. A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to Screening, or PML or other opportunistic infections at any time.
11. Prior treatment with total lymphoid irradiation.
12. Prior treatment with cladribine, mitoxantrone, fingolimod, T cell or T-cell receptor
vaccination, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or any therapeutic monoclonal antibody other than natalizumab within 24 months prior to randomization.
13. Prior treatment with intravenous immunoglobulin (IVIg), plasmapheresis, or cytapheresis within 12 months prior to randomization.
14. Treatment with IV or oral corticosteroids (inhaled corticosteroids are acceptable) or related products within 3 months prior to randomization.
15. Female subjects considering becoming pregnant while in the study.
16. Female subjects who are pregnant or currently breastfeeding.
17. History of drug or alcohol abuse within 2 years prior to entry.
18. 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.
19. Receiving any other investigational treatment within the 12 months prior to Screening or concurrent with this study.
20. Any pre-scheduled elective procedure during the study period that, in the opinion of the Investigator, would interfere with study endpoints.
21. Any other condition, clinical finding, or reason that, in the opinion of the Investigator and/or the Sponsor, is determined to be unsuitable for enrollment into this study.
22. Previous participation in this study.