NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-132178

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedMultiple Sclerosis
Date of first enrollment01/6/2013
Target sample size380
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : AIN457 INN of the intervention : secukinumab Dosage And administration of the intervention : AIN457 will be administered intravenously. Patients will be randomized to AIN457 Low/Middle/High dose. Control intervention name : Placebo Dosage And administration of the control intervention : Matching placebo will be administered intravenously.

Outcome(s)

Primary OutcomeCumulative number of new Gadolinium [Gd]-enhancing T1-weighted lesions [ Time Frame: Months 3, 4, 5, 6 ] Primary endpoint is the cumulative number of new Gd-enhancing T1-weighted lesions seen on brain MRI scans obtained at Months 3, 4, 5 and 6.
Secondary OutcomeAnnualized relapse rate [ Time Frame: 6 Months ] Annualized relapse rate is total number of relapses divided by total number of days on study, multiplied by 365.25 to obtain the annual rate. Combined unique active lesions (CUAL) [ Time Frame: Months 3, 4, 5, 6 ] New Gd-enhancing T1-weighted lesions or new/enlarging T2-weighted lesions avoiding double counting. Change in total volume of T2-weighted lesions [ Time Frame: Baseline, Month 6 ] Mean change in total volume of T2-weighted lesions at Month 6. Number of subjects with adverse events as a measure of safety and tolerability [ Time Frame: Baseline to Month 6 ] All AE/SAE will be reported in safety section of record.

Key inclusion & exclusion criteria

Age minimum18
Age maximum55
GenderBOTH
Include criteria*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
Exclude criteria*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.

Related Information

Contact

public contact
Name Novartis Pharma K.K. Novartis Direct
Address 0120-003-293
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scientific contact
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