- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941004
Safety and Efficacy of Fingolimod in MS Patients in China
April 20, 2017 updated by: Novartis Pharmaceuticals
A 12 Month Study, With a 6-month, Double-blind, Randomized, Placebo-controlled, Multi-center Parallel- Groups, Treatment Phase Evaluating Efficacy and Safety of Fingolimod 0.5 mg and a 6-month, Open-label, Treatment Phase, in Chinese Patients With Relapsing-remitting Multiple Sclerosis
To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
-Patients must have relapsing remitting multiple sclerosis
Exclusion Criteria:
Patients with:
- History of chronic immune disease
- Certain cancers
- Uncontrolled diabetes
- Certain eye disorders -Negative for varicella
- zoster virus IgG antibodies
- Certain hepatic conditions
- Low white blood cell count
- On certain immunosuppressive medications or heart medications
- Certain heart conditions or certain lung conditions
- Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.
- Other protocol defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: double blinded Fingolimod 6 mos + open label fingolimod 6 mos
Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
|
Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
|
Placebo Comparator: Placebo 6 mos + open label fingolimod 6 mos
Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
|
Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of new/newly enlarged T2 MRI lesions over 6 months
Time Frame: 6 months
|
Cumulative number of new/newly enlarged T2 lesions over 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
annualized relapse rate (ARR)
Time Frame: 6 months
|
The annualized relapse rate (ARR) is identified as the average number of confirmed relapses per year (the total number of confirmed relapses divided by the total days in the study multiplied by 365.25).
The number of relapses will include all the confirmed relapses during the study.
The time spent in the study will correspond to the observation period for all the relapses from first dose on the study drug to end of study.
|
6 months
|
number of Gd-enhancing T1 lesions
Time Frame: 6 months
|
6 months
|
|
Safety and tolerability of fingolimod 0.5 mg compared to placebo
Time Frame: 12 months
|
Based on frequency of adverse events (the number and percentage of patients having any AE by primary system organ class and preferred term) and on the incidence of clinically notable abnormalities
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Anticipated)
May 1, 2017
Study Completion (Anticipated)
May 1, 2017
Study Registration Dates
First Submitted
September 9, 2013
First Submitted That Met QC Criteria
September 9, 2013
First Posted (Estimate)
September 12, 2013
Study Record Updates
Last Update Posted (Actual)
April 21, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Immunosuppressive Agents
- Immunologic Factors
- Sphingosine 1 Phosphate Receptor Modulators
- Fingolimod Hydrochloride
Other Study ID Numbers
- CFTY720D2315
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis (Relapsing Remitting)
-
BiogenWithdrawnRelapsing-Remitting Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis
-
BiogenWithdrawn
-
BiogenAbbVieTerminatedMultiple Sclerosis | Relapsing-Remitting Multiple SclerosisUnited States, Denmark, Italy, United Kingdom, Czechia, Canada, Hungary, Spain, Australia, Israel, Georgia, Serbia, Russian Federation, Ukraine, India, Poland, Brazil, France, Argentina, Germany, Greece, Ireland, Mexico, Moldova, Republic... and more
-
EMD SeronoPfizerCompletedRelapsing-remitting Multiple SclerosisUnited States, United Kingdom, Argentina, Austria, Brazil, France, Germany, Italy, Netherlands, Russian Federation, Spain, Switzerland
-
National Institute of Allergy and Infectious Diseases...Immune Tolerance Network (ITN)CompletedRelapsing-Remitting Multiple SclerosisUnited States
-
BiogenTerminatedRelapsing-Remitting Multiple SclerosisUnited States, Spain, Germany, Australia, Sweden, Czechia, France, Italy, United Kingdom
-
Genzyme, a Sanofi CompanyTerminatedRelapsing-remitting Multiple SclerosisSweden, Poland, Russian Federation, United States, Canada
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple SclerosisGermany
-
Mitsubishi Tanabe Pharma CorporationCompletedRelapsing-remitting Multiple SclerosisCroatia, Bulgaria, Czech Republic, Italy, Russian Federation, Spain, United Kingdom, Germany, Lithuania, Poland, Belgium, Hungary, Serbia, Finland, Ukraine, Switzerland, Canada, Turkey
-
BiogenCompletedRelapsing-Remitting Multiple SclerosisUnited States
Clinical Trials on fingolimod
-
University Hospital, Basel, SwitzerlandNovartisCompletedRett's SyndromeSwitzerland
-
NovartisCompletedEfficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis (FREEDOMS)Relapsing-remitting Multiple SclerosisCanada, Australia, Israel, Belgium, Czech Republic, Finland, France, Germany, Greece, Lithuania, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Sweden, Switzerland, Turkey, United Kingdom
-
Hoffmann-La RochePPDRecruitingRelapsing-Remitting Multiple SclerosisUnited States, Belgium, Canada, Spain, India, Italy, Mexico, Portugal, Argentina, Austria, Brazil, United Kingdom, Germany, Netherlands, Serbia, Australia, Bulgaria, France, Greece, Hungary, Poland, Ukraine, Estonia, Denmark, Croatia, Latvia and more
-
NovartisCompletedMultiple SclerosisGreece, Russian Federation, Switzerland, Germany, Israel, Ireland, Belgium, Finland, United Kingdom, Netherlands, Canada, Romania, Hungary, Poland, Czech Republic, Australia, Estonia, France, Slovakia, South Africa, Sweden, Turkey
-
University Hospital, CaenRecruitingMultiple SclerosisFrance
-
Asofarma S.A.I. y C.Zenith Technology Corporation LimitedCompletedHealthy VolunteersNew Zealand
-
Novartis PharmaceuticalsCompletedRelapsing-remitting Multiple SclerosisGermany
-
Novartis PharmaceuticalsCompletedMultiple SclerosisColombia, Panama, Peru, Brazil, Jordan, Malaysia, Mexico, Argentina
-
Novartis PharmaceuticalsRecruiting