Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple Sclerosis
- Conditions
- Relapsing-Remitting Multiple SclerosisMedDRA version: 13.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2009-015556-15-SE
- Lead Sponsor
- Biogen Idec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 76
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 25 months prior to screening. (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 shown evidence of disease activity within 12 months prior to screening while on therapy. Disease activity must be observed after a minimum of 6 months of treatment but before 25 months of treatment.
Disease activity is defined as:
• One or more clinical relapses (Relapses must occur after 6 months of treatment, but before 25 months of treatment)
AND/OR
• Two or more new MRI lesions (Gd+ and/or T2 hyperintense) observed on an MRI scan. Qualifying lesions must be observed on scans performed after 6 months of treatment, but before 25 months of treatment. These qualifying scans must support at least one of the following:
a. =2 Gd+ lesions on MRI scan(s)
b. =2 new T2 hyperintense lesions observed on an MRI scan when compared with a *baseline MRI scan
c. =1 Gd+ lesion and =1 new T2 hyperintense lesion observed on an MRI scan when compared with a *baseline MRI scan
*A baseline MRI scan is an MRI scan performed at the initiation of therapy (±6 weeks) that is compared with subsequent MRI scans to determine if new T2 hyperintense lesions are observed. If this baseline scan at initiation of
therapy is not available, any scan performed after initiation of therapy may be used as the baseline MRI. New T2 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 76
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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.
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 within 30 days of randomization.
17. Treatment with 4-aminopyridine for subjects in countries where marketing
authorization has not been obtained. Treatment with compounded formulations of 4-aminopyridine is prohibited for all subjects.
18. Treatment with an approved formulation of 4-aminopyridine (i.e., fampridine-SR, dalfampridine, or Ampyra) for =90 days prior to randomization in countries where marketing authorization has been obtained.
19.Female subjects considering becoming pregnant while in the study.
20. Female subjects of childbearing potential who have a positive pregnancy test at either the Screening Visit or the Day 0 (Baseline) Visit.
21. Female subjects who are pregnan
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to provide study treatment in fulfillment of the commitments made in previous versions of the<br>protocol.;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable