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

• Conditions: Relapsing Remitting Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063399

• Registration Number: EUCTR2009-015556-15-IT
• Lead Sponsor: BIOGEN IDEC LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06-07
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

1. Have signed written informed consent 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 β-1a (44 mcg 3 times per week) as their principal first therapy for MS for 6 to 18 months prior to randomization. 4. Have had disease activity within 12 months prior to screening while on therapy; 5. Be na?ve 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). 2. Have known intolerance, contraindication to, or history of non-compliance with, the use of glatiramer acetate or interferon β-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 5. Subjects for whom MRI is contraindicated, 6. History of any clinically significant (as determined by the Investigator) 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 or hepatitis B virus and/or hepatitis B core antibody 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 (within 30 days prior to screening. 13. History of PML.

Study & Design

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