Status:
TERMINATED
Efficacy and Safety of AIN457 (Secukinumab) in Patients With Relapsing Multiple Sclerosis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.
Eligibility Criteria
Inclusion
- Diagnosis of Multiple Sclerosis according to 2010 revised McDonald criteria
- Disease duration of 10 years or less
- At least one relapse in the last year
- EDSS score 0 to 5.0 at entry
Exclusion
- Active chronic disease of the immune system other than multiple sclerosis
- History of malignancy within the past 5 years
- Active systemic bacterial, viral or fungal infections
- Previous treatment with more than one class of multiple sclerosis therapies except for previous treatment with glatiramer acetate and interferon-beta(s)
- Any medically unstable condition
- Unable to undergo MRI scans or repeated blood tests
- Pregnant or nursing females
- Women of child-bearing potential must use reliable forms of contraception
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT01874340
Start Date
June 1 2013
End Date
April 1 2014
Last Update
June 1 2015
Active Locations (13)
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1
Novartis Investigative Site
Bruges, Belgium, 8000
2
Novartis Investigative Site
Jihlava, Czechia, 586 33
3
Novartis Investigative Site
Saint-Herblain, France, 44800
4
Novartis Investigative Site
Roma, RM, Italy, 00133