Status:
TERMINATED
Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Remitting Multiple Sclerosis (RRMS)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.
Detailed Description
Patient were screened, signed an informed consent at visit 1, at the 2nd visit, all patient received a baseline infusion of Natalizumub and subsequently randomized to one of 3 treatment arms. At the r...
Eligibility Criteria
Inclusion
- Patients must:
- Have relapsing remitting multiple sclerosis
- Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.
Exclusion
- Patients with:
- History of chronic immune disease
- Crohn's disease
- Certain cancers
- Uncontrolled diabetes
- Certain eye disorders
- Negative for varicella-zoster virus IgG antibodies
- Certain hepatic conditions
- Low white blood cell count
- On certain immunosuppressive medications or heart medications
- Resting heart rate less than 45 bpm.
- Certain heart conditions or certain lung conditions
- Inability to undergo MRI scans
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT01499667
Start Date
September 1 2011
End Date
November 1 2012
Last Update
August 8 2014
Active Locations (44)
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1
Novartis Investigative Site
Box Hill, Victoria, Australia, 3128
2
Novartis Investigative Site
Heidelberg, Victoria, Australia, 3084
3
Novartis Investigative Site
Vienna, Austria, 1010
4
Novartis Investigative Site
Prague, Czechia, 128 08