Multiple SclerosisPhase 3NCT00662649
Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis
A Phase 3 study testing Fingolimod 0.5 mg and Fingolimod 1.25 mg in people with Multiple Sclerosis, run by Novartis at 103 sites in 22 countries.
Trial summary
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978). Read more about this study
- Who is it for?
- Ages 20 to 58 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fingolimod 0.5 mg and Fingolimod 1.25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 920 participants
- Where
- 103 sitesin 22 countries
- Study dates
- Feb 2008to Jun 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients should complete the 24 month core study
Who cannot join
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
103 sites in 22 countries.
103 sites in 22 countries
Germany11 sites
Novartis Investigative Site
Berlin
Novartis Investigative Site
Düsseldorf
Novartis Investigative Site
Giessen
Novartis Investigative Site
Hamburg
Novartis Investigative Site
Leipzig
Novartis Investigative Site
Magdeburg
Novartis Investigative Site
München
Novartis Investigative Site
Münster
Novartis Investigative Site
Regensburg
Novartis Investigative Site
Stuttgart
Novartis Investigative Site
Tübingen
France9 sites
Novartis Investigative Site
Clermont-Ferrand
Novartis Investigative Site
Dijon
Novartis Investigative Site
Lille
Novartis Investigative Site
Marseille
Novartis Investigative Site
Montpellier
Novartis Investigative Site
Nantes
Novartis Investigative Site
Paris
Novartis Investigative Site
Rennes
Novartis Investigative Site
Strasbourg
Canada8 sites
Novartis Investigative Site
Halifax
Novartis Investigative Site
Kingston
Novartis Investigative Site
London
Novartis Investigative Site
Montreal
Novartis Investigative Site
Nepean
Novartis Investigative Site
Regina
Novartis Investigative Site
Toronto
Novartis Investigative Site
Vancouver
Czechia8 sites
Novartis Investigative Site
Brno
Novartis Investigative Site
Olomouc
Novartis Investigative Site
Ostrava-Poruba
Novartis Investigative Site
Pardubice
Novartis Investigative Site
Plzen - Lochotin
Novartis Investigative Site
Prague
Novartis Investigative Site
Rychnov nad Kněžnou
Novartis Investigative Site
Teplice
Turkey (Türkiye)8 sites
Novartis Investigational Site
Ankara
Novartis Investigational Site
Bursa
Novartis Investigational Site
Cerrahpasa/Istanbul
Novartis Investigational Site
Gaziantep
Novartis Investigational Site
Istanbul
Novartis Investigational Site
Izmir
Novartis Investigational Site
Mersin
Novartis Investigational Site
Yenisehir/Izmir
Belgium7 sites
Novartis Investigative Site
Bruges
Novartis Investigative Site
Brussels
Novartis Investigative Site
Charleroi
Novartis Investigative Site
Leuven
Novartis Investigative Site
Overpelt
Novartis Investigative Site
Sijsele - Damme
Novartis Investigative Site
Sint-Truiden
Netherlands6 sites
Novartis Investigative Site
Amsterdam
Novartis Investigative Site
Nieuwegein
Novartis Investigative Site
Nijmegen
Novartis Investigative Site
Rotterdam
Novartis Investigative Site
Sittard
Novartis Investigative Site
Tilburg
Poland6 sites
Novartis Investigative Site
Bialystok
Novartis Investigative Site
Gdansk
Novartis Investigative Site
Katowice
Novartis Investigative Site
Lodz
Novartis Investigative Site
Poznan
Novartis Investigative Site
Warsaw
Australia5 sites
Novartis Investigative Site
Chatswood
Novartis Investigative Site
Fitzroy, 3065
Austin Health, Department of Neurology
Heidelberg
Novartis Investigative Site
North Gosford
Novartis Investigative Site
Woodville
United Kingdom5 sites
Novartis Investigative Site
Bristol
Novartis Investigative Site
London
Novartis Investigative Site
Newcastle upon Tyne
Novartis Investigative Site
Nottingham
Novartis Investigative Site
Sheffield
Israel4 sites
Novaratis Investigative Site
Ashkelon
Novartis Investigative Site
Haifa
Novartis Investigative Site
Ramat Gan
Novartis Investigative Site
Safed
Romania4 sites
Novartis Investigative Site
Bucharest
Novartis Investigative Site
Craiova
Novartis Investigative Site
Lasi
Novartis Investigative Site
Tg. Mures
Finland3 sites
Novartis Investigative Site
Helsinki
Novartis Investigative Site
Tampere
Novartis Investigative Site
Turku
Hungary3 sites
Novartis Investigative Site
Budapest
Novartis Investigative Site
Miskolc
Novartis Investigative Site
Székesfehérvár
Russia3 sites
Novartis Investigative Site
Kazan'
Novartis Investigative Site
Moscow
Novartis Investigative Site
Saint Petersburg
Slovakia3 sites
Novartis Investigational Site
Bratislava
Novartis Investigative Site
Martin
Novartis Investigational Site
Žilina
South Africa3 sites
Novartis Investigational Site
Cape Town
Novartis Investigational Site
Rosebank
Novartis Investigational Site
Umhlanga
Sweden2 sites
Novartis Investigational Site
Gothenburg
Novartis Investigational Site
Stockholm
Switzerland2 sites
Novartis Investigative Site
Lausanne
Novartis Investigative Site
Zurich
About this study
Official title: An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
- Conditions
- Multiple Sclerosis
- Being tested
- Fingolimod 0.5 mg, Fingolimod 1.25 mg
- Keywords
- Multiple sclerosis., Relapse-remitting, Fingolimod
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fingolimod 0.5 mgDrug
Also called FTY720
Patients self-administered fingolimod 0.5 mg capsules orally once daily.
Fingolimod 1.25 mgDrug
Also called FTY720
Patients self-administered fingolimod 1.25 mg capsules orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod 1.25 mg | Experimental | Patients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study. Receives: Drug: Fingolimod 1.25 mg |
| Fingolimod 0.5 mg | Experimental | Patients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. Receives: Drug: Fingolimod 0.5 mg |
| Placebo-fingolimod | Experimental | Patients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study. Receives: Drug: Fingolimod 0.5 mg; Drug: Fingolimod 1.25 mg |
| Placebo-fingolimod 1.25 mg | Experimental | Patients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study. Receives: Drug: Fingolimod 1.25 mg |
| Placebo-fingolimod 0.5 mg | Experimental | Patients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study. Receives: Drug: Fingolimod 0.5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Measured: Months 0 to end of study (maximum up to 60 months)
Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
Measured: Core baseline to end of study (maximum up to 60 months)
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Measured: Months 0-24 (core study) and Months 24-48 (extension study)
Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Measured: Months 0-24 (core study) and Months 24-48 (extension study)
Secondary outcomes (5)
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Measured: Months 0-24 (core study) and Months 24-48 (extension study)
Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
The number of new or newly enlarged T2 lesions was assessed with T2-weighted MRI scans. A T2-weighted MRI scan utilizes particular values of the echo time (TE) and the repetition time (TR) parameters of image acquisition. Inflammation and tissue damage are seen as bright areas in T2 images and are often referred to as T2 lesions. T2 weighted MRI scans are a sensitive way to evaluate the brain for demyelinating diseases, such as multiple sclerosis.
Measured: Months 0-24 (core study) and Months 24-48 (extension study)
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Measured: Months 0-24 (core study) and Months 24-48 (extension study)
Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
Calculations of brain volume change were performed using the structural image evaluation of normalized atrophy (SIENA), software included in the Functional Magnetic Resonance Imaging of the Brain (FMRIB) software library. SIENA is a fully automated method for estimating temporal brain volume change.
Measured: Months 0 to end of study (maximum up to 60 months)
Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
Kurtzke's Expanded Disability Status Scale (EDSS) is a scale for assessing neurologic impairment in multiple sclerosis (MS) includes a series of scores in each of eight functional systems such as Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel \& Bladder, Cerebral, and Other. The EDSS steps range from 0 (normal) to 10 (death due to MS). The Kaplan-Meier estimates of the percentage of participants free of disability progression at end of study and their 95% CIs were provided for each treatment group.
Measured: Core baseline to end of study (maximum up to 60 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 920 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662649
- Sponsor's protocol ID
- CFTY720D2301E1
- Other IDs
- 2007-004122-24
- Status last verified
- Jun 2012
- First submitted
- 17 Apr 2008
- Last updated
- 12 Jul 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extension of the 24-month, Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing Efficacy and Safety of Fingolimod (FTY720) 1.25 mg and 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Relapsing-remitting Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00662649
- Acronym / sponsor ID
- CFTY720D2301E1
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis., Relapse-remitting, Fingolimod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 920 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 12 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This extension study of was designed to evaluate the long-term safety, tolerability, and efficacy of fingolimod (FTY720) in patients with multiple sclerosis. The Extension study was an extension to the 24-month Core study (CFTY720D2301/NCT00289978).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Fingolimod 1.25 mg | Experimental | Drug: Fingolimod 1.25 mgPatients continued the same dose to which they had been randomized in the Core study (CFTY720D2301/NCT00289978), fingolimod 1.25 mg/day, in this Extension study. |
| Fingolimod 0.5 mg | Experimental | Drug: Fingolimod 0.5 mgPatients continued the same dose to which they had been randomized in the Core study, fingolimod 0.5 mg/day, in this Extension study. |
| Placebo-fingolimod | Experimental | Drug: Fingolimod 0.5 mg, Drug: Fingolimod 1.25 mgPatients randomized to placebo in the Core study were re randomized to fingolimod (either 0.5 or 1.25 mg/day) in this Extension study. |
| Placebo-fingolimod 1.25 mg | Experimental | Drug: Fingolimod 1.25 mgPatients randomized to placebo in the Core study were re randomized to fingolimod 1.25 mg/day in this Extension study. |
| Placebo-fingolimod 0.5 mg | Experimental | Drug: Fingolimod 0.5 mgPatients randomized to placebo in the Core study were re randomized to fingolimod 0.5 mg/day in this Extension study. |
Who may qualify
- Ages
- 20 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients should complete the 24 month core study
Key exclusion criteria (3 listed)
- Patients with other chronic disease of the immune system, malignancies, acute pulmonary disease, cardiac failure, etc.
- Pregnant or nursing women
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Fingolimod 0.5 mgAlso: FTY720Patients self-administered fingolimod 0.5 mg capsules orally once daily. | Drug | Fingolimod 0.5 mg, Placebo-fingolimod, Placebo-fingolimod 0.5 mg |
| Fingolimod 1.25 mgAlso: FTY720Patients self-administered fingolimod 1.25 mg capsules orally once daily. | Drug | Fingolimod 1.25 mg, Placebo-fingolimod, Placebo-fingolimod 1.25 mg |
Primary outcome
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study)
Time frame: Months 0 to end of study (maximum up to 60 months)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Time to First Confirmed Relapse up to End of Study: Kaplan-Meier Estimate of Percentage of Patients Relapse-free
Time frame: Core baseline to end of study (maximum up to 60 months)
A relapse was confirmed when it was accompanied by an increase of at least half a step (0.5) on the Expanded Disability Status Scale (EDSS) or an increase of 1 point on two different Functional Systems (FS) of the EDSS or 2 points on one of the FS (excluding Bowel/Bladder or Cerebral FS). Kaplan-Meier estimates of the percentage of relapse-free patients at end of study and and 95% confidence intervals (CIs) were presented for the treatment groups.
Annualized Aggregate Relapse Rate (ARR) During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Time frame: Months 0-24 (core study) and Months 24-48 (extension study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
Change (Expressed as Ratio) in the Annualized Aggregate Relapse Rate (ARR) From Months 0-24 (Core Study) to Months 24-48 (Extension Study)
Time frame: Months 0-24 (core study) and Months 24-48 (extension study)
ARR is defined as the number of confirmed relapses in a year. A relapse is defined as the appearance of a new or worsening of a previously stable or improving pre-existing neurological abnormality, separated by at least 30 days from onset of a preceding relapse. The abnormality must be present for at least 24 hours and occur in the absence of fever or infection. The annualized ARR for each treatment group was the mean of the annualized ARRs for all patients in the group, calculated as the total number of confirmed relapses divided by the total number of days on study multiplied by 365.25.
5 secondary outcomes
Change in Mean Number of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Time frame: Months 0-24 (core study) and Months 24-48 (extension study)
Percentage of Patients Free of New or Newly Enlarged T2 Magnetic Resonance Imaging (MRI) Lesions During Months 0-24 (Core Study) and Months 24-48 (Extension Study)
Time frame: Months 0-24 (core study) and Months 24-48 (extension study)
Percent Change in Brain Volume From Month 0 to Month 24 (Core Study) and From Month 24 to Month 48 (Extension Study)
Time frame: Months 0-24 (core study) and Months 24-48 (extension study)
Percent Change in Brain Volume From Month 0 End of Study (Core and Extension Study)
Time frame: Months 0 to end of study (maximum up to 60 months)
Time to First 3-month Confirmed Disability Progression up to End of Study Based on Expanded Disability Status Scale (EDSS): Kaplan-Meier Estimate of Percentage of Patients Free of Disability Progression
Time frame: Core baseline to end of study (maximum up to 60 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Fingolimod clinical trials information websiteLink provided by the sponsor.
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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 chair
Novartis Pharmaceuticals
103 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fingolimod 0.5 mg and Fingolimod 1.25 mg in people with Multiple Sclerosis, run by Novartis at 103 sites in 22 countries.
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 3 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: finished, as of the sponsor's last update on 12 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 103 sites in Germany, France, Canada, Czechia, Turkey (Türkiye) and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 12 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Annualized Aggregate Relapse Rate (ARR) During Months 0 to End of Study(Core [CFTY720D2301/NCT00289978] and Extension Study) (time frame: Months 0 to end of study (maximum up to 60 months)). The study lists 4 primary outcomes in all. 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 12 Jul 2012.