Phase 2 N=73 Randomized Double-blind Treatment

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

Relapsing-remitting Multiple Sclerosis · RRMS

Bottom Line

View on ClinicalTrials.gov: NCT01051817 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2015

Primary outcome: Primary: Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment — 2.4; 3.2; 3.9; 5.4 Combined Unique Active Lesions

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AIN457 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Summary of Raw Number of Cumulative Combined Unique Active Lesions in Patients With Relapsing Remitting Multiple Sclerosis by Visit and Treatment	2.4; 3.2; 3.9; 5.4; 5.4; 8.6	—
SECONDARY Raw Number of Cumulative New Gd-T1 Lesions	1.4; 1.7; 2.6; 3.0; 4.3; 5.5	—
SECONDARY Raw Number of Cumulative New Gd-T2 Lesions	2.3; 3.1; 3.6; 5.4; 5.0; 8.3	—

Summary

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

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01051817). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.