A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS

• Conditions: Relapsing-Remitting Multiple Sclerosis; MedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis

• Registration Number: EUCTR2009-015556-15-PT
• Lead Sponsor: Biogen Idec Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-30
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1800

Inclusion Criteria

1.Have signed written informed consent (in person or through guardian) to participate in the study and provided written authorization to use protected health information in accordance with local laws.
2.Have a diagnosis of relapsing remitting multiple sclerosis as defined by the revised McDonald Committee criteria (Polman 2005).
3.Must have been treated with a stable regimen of either glatiramer acetate (20 mg per day SC) or interferon ß-1a (44 mcg 3 times per week) as their principal first therapy for MS for 6 to 18 months prior to randomization. (Note: prior treatment with another MS therapy of =30 days total duration is not exclusionary [e.g. titration to 44 mcg is allowed]).
4.Have had disease activity within 12 months prior to screening while on therapy. Qualifying disease activity is defined as:
•One or more clinical relapses
OR
•Two or more new MRI lesions (Gd+ and/or T2 hyperintense)
For inclusion purposes: (a) a relapse is defined as neurologic signs and/or symptoms documented in the medical record by a neurologist and of sufficient duration to be determined by the Investigator or the Treating Physician as consistent with an MS relapse or (b) MRI activity must be verified by the central reader center.
5.Be naïve to natalizumab.
6.Be between the ages of 18 and 60, inclusive at the time of informed consent.
7.Have a documented EDSS score between 0.0 and 5.5, inclusive.

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.Have a diagnosis of primary progressive, secondary progressive, or progressive relapsing MS (as defined by Lublin and Reingold, 1996). These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Patients with these conditions may also have superimposed relapses, but are distinguished from relapsing-remitting patients by the lack of clinically stable periods or clinical improvement.
2.Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon ß-1a.
3.Have had an MS exacerbation (relapse) within 30 days prior to randomization AND/OR the patient has not stabilized from a previous relapse, in the opinion of the Investigator, prior to randomization.
4.The patient is considered by the Investigator to be immunocompromised based on medical history, physical examination, laboratory testing, or due to prior immunosuppressive or immunomodulating treatment.
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 gadolinium (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, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical trial.
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.Known history of Human Immunodeficiency Virus (HIV).
9.Positive test result for Hepatitis C virus (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]).
10.History of transplantation or any anti-rejection therapy.
11.History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
12.A clinically significant infectious illness (e.g. cellulitis, abscess, pneumonia, septicemia) within 30 days prior to screening.
13.History of PML.
Treatment History
14.Prior treatment with total lymphoid irradiation, cladribine, mitoxantrone, fingolimod, T cell or T-cell receptor vaccination, cyclophosphamide, cyclosporine, azathioprine, methotrexate, mycophenolate mofetil, or any therapeutic monoclonal antibody, including natalizumab or rituximab.
15.Prior treatment with intravenous immunoglobulin (IVIg), plasmapheresis or cytapheresis within 6-months prior to randomization.
16.Treatment with IV or oral corticosteroids or 4-aminopyridine or related products within 30 days of randomization.
Miscellaneous
17.Female subjects considering becoming pregnant while in the study.
18.Female subjects of childbearing potential who have a positive pregnancy test at either the Screening Visit or the Day 0 (Baseline) Visit.
19.Female subjects who are pregnant or currently breastfeeding.
20.History of drug or alcohol abuse within 2 years prior to entry.
21.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 patient's ability to comply with the study protocol.
22.Participation in any other investigatio

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified