Status:
COMPLETED
Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)
Lead Sponsor:
Biogen
Conditions:
Relapsing-Remitting Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).
Detailed Description
This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months accordi...
Eligibility Criteria
Inclusion
- Key
- Ability to provide written informed consent
- Subjects of childbearing potential must practice effective contraception during the study
- A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)
- Free of MS relapse for 12 months prior to randomization
- Treatment with natalizumab for a minimum of 12 months immediately prior to randomization.
- In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse.
- Key
Exclusion
- Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus
- Positive for anti-natalizumab antibodies at screening
- MRI positive for Gd-enhancing lesions at study entry
- Subjects for whom MRI is contraindicated
- History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease
- History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin)
- History of transplantation or any anti-rejection therapy
- History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug
- A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time
- Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT01405820
Start Date
August 1 2011
End Date
October 1 2014
Last Update
August 21 2015
Active Locations (64)
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1
Research Site
Brasschaat, Belgium
2
Research Site
Liège, Belgium
3
Research Site
Overpelt, Belgium
4
Research Site
Wilrijk, Belgium