NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Multiple Sclerosis
Date of first enrollment	01/6/2013
Target sample size	380
Countries of recruitment
Study type	INTERVENTIONAL
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 Outcome

Cumulative 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 Outcome

Annualized 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 minimum	18
Age maximum	55
Gender	BOTH
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.