NCT01051817

Brief 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2009

Geographic Reach
3 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 27, 2015

Completed
Last Updated

February 27, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

January 19, 2010

Results QC Date

February 12, 2015

Last Update Submit

February 12, 2015

Conditions

Relapsing-remitting Multiple SclerosisRRMS

Keywords

relapsing-remitting multiple sclerosisRRMS

Outcome Measures

Primary Outcomes (1)

  • 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.

    weeks 4,8,12,16,20,24,28

Secondary Outcomes (2)

  • Raw Number of Cumulative New Gd-T1 Lesions

    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

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

Study Arms (2)

AIN457

EXPERIMENTAL
Drug: AIN457

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

AIN457DRUG

infusion 10 mg/Kg

AIN457
PlaceboDRUG

infusion

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Novartis Investigative Site

Hradec Králové, Czech Republic, 500 05, Czechia

Location

Novartis Investigative Site

Ostrava, Czechia

Location

Novartis Investigative Site

Ostrava-Moravska Ostrava, Czechia

Location

Novartis Investigative Site

Prague, 128 08, Czechia

Location

Novartis Investigative Site

Prague, Czechia

Location

Novartis Investigative Site

Teplice, 415 29, Czechia

Location

Novartis Investigative Site

Kazan', 420021, Russia

Location

Novartis Investigative Site

Moscow, 129128, Russia

Location

Novartis Investigative Site

Nizhny Novgorod, 603155, Russia

Location

Novartis Investigative Site

Smolensk, 214019, Russia

Location

Novartis Investigative Site

Kharkiv, 61068, Ukraine

Location

Novartis Investigative Site

Kharkiv, Ukraine

Location

Novartis Investigative Site

Kiev, 03110, Ukraine

Location

Novartis Investigative Site

Kiev, Ukraine

Location

Novartis Investigative Site

Odesa, 65025, Ukraine

Location

Novartis Investigative Site

Vinnitsya, 21005, Ukraine

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

secukinumab

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Study Start

December 1, 2009

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

February 27, 2015

Results First Posted

February 27, 2015

Record last verified: 2015-02

Locations

UA(6)CZ(6)RU(4)