Multiple Sclerosis (Relapsing Remitting)Phase 3NCT01941004
Safety and Efficacy of Fingolimod in MS Patients in China
A Phase 3 study testing fingolimod in people with Multiple Sclerosis (Relapsing Remitting), run by Novartis Pharmaceuticals.
Trial summary
To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Multiple Sclerosis (Relapsing Remitting)
- What is being tested?
- fingolimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to May 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Patients must have relapsing remitting multiple sclerosis
Who cannot join
- Patients with:
- History of chronic immune disease
- Certain cancers
- Uncontrolled diabetes
- Certain eye disorders -Negative for varicella
- zoster virus IgG antibodies
Show all 12Show fewer
- 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
About this study
Official title: 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
- Conditions
- Multiple Sclerosis (Relapsing Remitting)
- Being tested
- fingolimod, Placebo (6mos) + open label fingolimod (6 mos)
- Keywords
- multiple sclerosis (MS), relapsing remitting multiple sclerosis (RRMS), fingolimod
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fingolimodDrug
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 (6mos) + open label fingolimod (6 mos)Drug
Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
| Study group | Role | What they receive |
|---|---|---|
| double blinded Fingolimod 6 mos + open label fingolimod 6 mos | Experimental | 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 Receives: Drug: fingolimod |
| Placebo 6 mos + open label fingolimod 6 mos | Placebo comparator | Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily Receives: Drug: Placebo (6mos) + open label fingolimod (6 mos) |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of new/newly enlarged T2 MRI lesions over 6 months
Cumulative number of new/newly enlarged T2 lesions over 6 months
Measured: 6 months
Secondary outcomes (3)
annualized relapse rate (ARR)
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.
Measured: 6 months
number of Gd-enhancing T1 lesions
Measured: 6 months
Safety and tolerability of fingolimod 0.5 mg compared to placebo
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startJun 2014
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (Relapsing Remitting)Studies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941004
- Sponsor's protocol ID
- CFTY720D2315
- Status last verified
- Apr 2017
- First submitted
- 9 Sep 2013
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01941004
- Acronym / sponsor ID
- CFTY720D2315
- Conditions
- Multiple Sclerosis (Relapsing Remitting)
- Keywords
- multiple sclerosis (MS), relapsing remitting multiple sclerosis (RRMS), fingolimod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double blinded Fingolimod 6 mos + open label fingolimod 6 mos | Experimental | Drug: fingolimodRandomized 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 6 mos + open label fingolimod 6 mos | Placebo comparator | Drug: Placebo (6mos) + 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Patients must have relapsing remitting multiple sclerosis
Key exclusion criteria (12 listed)
- History of chronic immune disease
- Certain cancers
- Uncontrolled diabetes
- Certain eye disorders -Negative for varicella
- zoster virus IgG antibodies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fingolimodRandomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily | Drug | double blinded Fingolimod 6 mos + open label fingolimod 6 mos |
| Placebo (6mos) + 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 | Drug | Placebo 6 mos + open label fingolimod 6 mos |
Primary outcome
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
3 secondary outcomes
annualized relapse rate (ARR)
Time frame: 6 months
number of Gd-enhancing T1 lesions
Time frame: 6 months
Safety and tolerability of fingolimod 0.5 mg compared to placebo
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fingolimod in people with Multiple Sclerosis (Relapsing Remitting), run by Novartis Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of new/newly enlarged T2 MRI lesions over 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2017.