Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01051817
  4. Details
NCT01051817 Clinical Trial

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

Relapsing-remitting Multiple Sclerosis Clinical Trial

Official title:
A Randomized, Multi-center, Double-blind, Proof-of-concept Study to Assess the Effect of Multiple Infusion 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01051817
Other study ID # CAIN457B2201
Secondary ID 2009-011626-34
Status Completed
Phase Phase 2
First received January 19, 2010
Last updated February 12, 2015
Start date December 2009
Est. completion date April 2012

Study information
Verified date February 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date April 2012
Est. primary completion date April 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• AIN457
infusion 10 mg/Kg
• Placebo
infusion

Locations
Country Name City State
Czech Republic Novartis Investigative Site Hradec Kralove
Czech Republic Novartis Investigative Site Ostrava
Czech Republic Novartis Investigative Site Ostrava-Moravska Ostrava
Czech Republic Novartis Investigative Site Praha 10
Czech Republic Novartis Investigative Site Praha 2
Czech Republic Novartis Investigative Site Teplice
Russian Federation Novartis Investigative Site Kazan
Russian Federation Novartis Investigative Site Moscow
Russian Federation Novartis Investigative Site Nizhny Novgorod
Russian Federation Novartis Investigative Site Smolensk
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kiev
Ukraine Novartis Investigative Site Kiev
Ukraine Novartis Investigative Site Odessa
Ukraine Novartis Investigative Site Vinnitsya

Sponsors (1)
Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Czech Republic,  Russian Federation,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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. MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). No
Secondary 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. MRI brain scans performed every 4 weeks at week 4, 8, 12, 16, 20, 24 and 28 (EOS). No
See also
  Status Clinical Trial Phase
Completed NCT02549703 - Mitochondrial Dysfunction and Disease Progression
Completed NCT02293967 - Mass Balance Study of MT-1303 Phase 1
Terminated NCT02222948 - Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis Phase 2
Terminated NCT01790269 - Monitoring Natural Killer Cells in Multiple Sclerosis Patients Treated With Fingolimod
Terminated NCT01701856 - Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis Phase 4
Completed NCT00525668 - Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study) Phase 1/Phase 2
Terminated NCT00398528 - An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple Sclerosis Phase 4
Completed NCT00315367 - A fMRI(Functional Magnetic Resonance Imaging) Research Study to Learn More About Multiple Sclerosis and Individuals Potentially Experiencing Memory Difficulties Phase 4
Terminated NCT04032171 - Study of Evobrutinib in Participants With RMS Phase 3
Completed NCT01930708 - A Study Evaluating the Effectiveness of Tecfidera (Dimethyl Fumarate) on Multiple Sclerosis (MS) Disease Activity and Patient-Reported Outcomes Phase 4
Completed NCT03000647 - Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis N/A
Completed NCT02205489 - Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA Phase 4
Completed NCT02753088 - Efficacy and Safety of BCD-063 and Copaxone-Teva in Patients With Relapsing-Remitting Multiple Sclerosis Phase 3
Recruiting NCT01466114 - Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition Phase 2
Completed NCT01416155 - Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple Sclerosis Phase 2
Completed NCT01244139 - Safety Study of BIIB033 in Subjects With Multiple Sclerosis Phase 1
Completed NCT00559702 - Safety Study of Natalizumab to Treat Multiple Sclerosis (MS) Phase 1
Completed NCT00493116 - Is IFN-beta Treatment in MS Useful After a Washout Period in Patients With Neutralizing Antibodies to Interferon Beta Phase 4
Terminated NCT01706107 - Canadian Multicenter Observational Study of Tysabri in Early Relapsing Remitting Multiple Sclerosis Participants
Completed NCT01943526 - Ireland Natalizumab (TYSABRI) Observational Program