POC-MD MRI-based Trial in Relapsing-remitting Multiple Scler

Novartis Pharmaceuticals73 enrolled

Overview

A randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of AIN457 (10 mg/kg) versus placebo on disease activity as measured by MRI scans over a 24 week period in patients with relapsing-remitting multiple sclerosis

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Relapsing-remitting Multiple Sclerosis RRMS

Interventions

AIN457DRUG

infusion 10 mg/Kg

PlaceboDRUG

infusion

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Exclusion Criteria: \-

Locations (16)

Novartis Investigative Site

Hradec Králové, Czech Republic, Czechia

Novartis Investigative Site

Ostrava, Czechia

Novartis Investigative Site

Ostrava-Moravska Ostrava, Czechia

Outcomes

Primary Outcomes

Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment

Combined unique active lesions (CUAL) observed on brain MRI scans performed every 4th week from week 4 to week 24 in patients with relapsing-remitting multiple sclerosis (RRMS). CUAL is defined as: new gadolinium (Gd)-enhancing lesions on T1-weighted, or new or enlarging lesions on T2-weighted MRI scans, without double counting.

Time frame: weeks 4,8,12,16,20,24,28

Secondary Outcomes

Raw Number of Cumulative New Gd-T1 Lesions

The summary of raw number of cumulative new Gadolinium-enhanced T1 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The end-point is week 24.

Time frame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).

Raw Number of Cumulative New Gd-T2 Lesions

The summary of raw number of cumulative new Gadolinium-enhanced T2 lesions observed on brain MRI scans performed every 4th week from WK 4 to WK 28. The endpoint is week 24.

Time frame: MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS).

Data from ClinicalTrials.gov

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