Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study One

Phase 3

Completed

• Conditions: Multiple sclerosis; Nervous System Diseases

• Registration Number: ISRCTN21534255
• Lead Sponsor: Genzyme Corporation (USA)

Brief Summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23122652

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-03-11
• Study Completion: 2011-03-01
• Last Update Posted: 6 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 581

Inclusion Criteria

Amended as of 22/06/2009:
Point 6 below has been removed from the inclusion criteria.

Initial information at time of registration:
1. Males and females, aged 18 - 50 years
2. Diagnosis of multiple sclerosis (MS) and cranial magnetic resonance imaging (MRI) scan demonstrating white matter lesions attributable to MS within 5 years
3. Onset of MS symptoms within 5 years of screening
4. Expanded Disability Status Scale (EDSS) score 0.0 to 3.0
5. Greater than or equal to 2 MS attacks within 24 months, with greater than or equal to 1 attack within 12 months
6. Neurologically stable for the 30 days prior to the date the Informed Consent Form is signed

Exclusion Criteria

1. Received prior therapy for MS other than corticosteroids
2. Exposure to immunosuppressive or immunomodulatory agents other than systemic corticosteroid treatment
3. Received treatment with a monoclonal antibody for any reason
4. Previous treatment with any investigational drug (i.e. medication that is not approved at any dose for any indication)
5. Has any progressive form of MS
6. Any disability acquired from trauma or another illness that could interfere with evaluation of disability due to MS
7. Major systemic disease that cannot be treated or adequately controlled by therapy
8. Active infection or high risk for infection
9. Autoimmune disorder (other than MS)
10. Impaired hepatic or renal function
11. History of malignancy, except basal skin cell carcinoma
12. Medical, psychiatric, cognitive, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
13. Known bleeding disorder
14. Of childbearing potential with a positive serum pregnancy test, pregnant, or lactating
15. Current participation in another clinical study
16. Previous hypersensitivity reaction to any immunoglobulin product
17. Known allergy or intolerance to interferon beta, human albumin, or mannitol
18. Intolerance of pulsed corticosteroids, especially a history of steroid psychosis
19. Inability to self-administer subcutaneous (SC) injections or receive SC injections from caregiver
20. Inability to undergo MRI with gadolinium administration
21. Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)

Study & Design

• Study Type: Interventional
• Study Design: Not specified