Multiple Sclerosis, Relapsing Forms of Multiple SclerosisPhase 4ACROSSNCT02307838
Long-term Follow-up of Fingolimod Phase II Study Patients
A Phase 4 study testing Assessments arm in people with Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 26 sites in 10 countries.
Trial summary
This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
- What is being tested?
- Assessments arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 26 sitesin 10 countries
- Study dates
- Jun 2014to Dec 2015
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Randomized in study FTY720D2201 and received at least one dose of study drug.
Who cannot join
- None
Trial locations and contacts
26 sites in 10 countries.
26 sites in 10 countries
Spain6 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
L'Hospitalet de Llobregat, Catalonia, 08907
Novartis Investigative Site
Madrid, Madrid, 28040
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Seville, Andalusia, 41009
Novartis Investigative Site
Valencia, Valencia, 46026
Canada4 sites
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Montreal, Quebec, H3A 2B4
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Toronto, Ontario, M5B 1N9
Italy4 sites
Novartis Investigative Site
Gallarate, VA, 21013
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Roma, RM, 00189
Denmark2 sites
Novartis Investigative Site
Copenhagen, DK-2100
Novartis Investigative Site
Glostrup Municipality, DK-2600
France2 sites
Novartis Investigative Site
Lille, 59037
Novartis Investigative Site
Marseille, France, 13385
Poland2 sites
Novartis Investigative Site
Warsaw, 02-097
Novartis Investigative Site
Warsaw, 02-957
Portugal2 sites
Novartis Investigative Site
Coimbra, Portugal, 3000-075
Novartis Investigative Site
Lisbon, Portugal, 1150-314
Switzerland2 sites
Novartis Investigative Site
Basel, 4031
Novartis Investigative Site
Zurich, 8091
United Kingdom1 site
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP
About this study
Official title: Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)
This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).
Read the detailed description
This was a multicenter follow-up study of patients originally enrolled in the Phase 2 D2201 study. Patients did not receive any protocol specified treatment. The original D2201 study sites who agreed to participate in this study were required to locate their patients who were randomized in Study D2201 and asked them to return for a 10-year assessment, regardless of their current treatment status. Locating the patient may have required the use of search and advertising strategies to find those patients currently lost to follow-up, in accordance with local privacy legislation. Patients currently being followed within Study FTY720D2399 (NCT01201356) were asked to participate in Study FTY720D2201E2 and if patients gave consent, were enrolled concurrently in both studies.
- Being tested
- Assessments arm
- Keywords
- Multiple Sclerosis, MS, RRMS, relapsing forms of multiple sclerosis, fingolimod, FTY720, Gilenya
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessments armOther
Protocol required assessments not provided in standard of care
| Study group | Role | What they receive |
|---|---|---|
| Phase 2 CFTY720D2201 (NCT02307838) participants | Other | CFTY720D2201E2 participants did not receive any protocol specified treatment. The original D2201 study sites, who agreed to participate in this study, were required to locate their participants who were randomized in D2201 and asked them to return for a 10 year assessment, regardless of current treatment status. Receives: Other: Assessments arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Secondary outcomes (16)
Number of Participants With Disability Progression
Disability progression is defined as: 1.5-point increase from baseline in participants with baseline EDSS score = 0.0; OR 1-point increase in EDSS from baseline in participants with baseline EDSS score of 1.0 to 5.0 inclusive; OR 0.5-point increase in EDSS from baseline in participants with baseline EDSS score >5.0.
Measured: 10 Years
Number of Participants With EDSS <4 or <6
EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A positive change from baseline indicates improvement.
Measured: 10 years
Number of Participants Not Using a Wheelchair or Being Bedridden
The number of participants not using a wheelchair or being bedridden was assessed.
Measured: 10 years
Number of Participants Classified as Secondary Progressive MS (SPMS)
SPMS follows an initial relapsing-remitting course. Most people who are diagnosed with relapsing-remitting multiple sclerosis (RRMS) will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Participants who were classified as SPMS were assessed.
Measured: 10 years
Percentage of Participants With First Use of an Ambulatory Device
First use of an ambulatory device was considered from EDSS 6.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 6.0.
Measured: 10 years
Percentage of Participants With First Use of a Wheelchair
First use of a wheelchair was considered from EDSS 7.0 for participants having started FTY720D2201 (NCT00333138) with an EDSS score below 7.0.
Measured: 10 years
Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)
The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). The time limit per trial is 300 seconds. The right and left hand scores were the time in seconds it took to insert and remove 9 pegs ((the average scores from the four trials on the 9-HPT (the two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged)). A negative change from baseline indicates improvement.
Measured: baseline from core study, CFTY720D2201 (NCT00333138), 10 years
Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score
The PASAT is a measure of cognitive function that specifically assesses auditory information processing speed and flexibility, as well as calculation ability. The PASAT is the last measure administered at each visit. It is presented on audio compact disc (CD) to control the rate of stimulus presentation. Single digits are presented every 3 seconds and the patient must add each new digit to the one immediately prior to it. The test result is the number of correct sums given (out of 60 possible). A positive change from baseline indicates improvement.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score
The Timed 25-Foot Walk is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot (7.62 m) course and is instructed to walk 25 feet (7.62 meter) as quickly as possible, but safely. The task is immediately administered again by having the patient walk back the same distance. Patients may use assistive devices when doing this task. The test scores were the time in seconds it took to walk the 25 feet. A negative change from baseline indicates improvement.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score
MSFC is a composite measure encompassing information from the nine-hole peg test (arm dimension), timed 25 foot walk (leg dimension) and PASAT. The MSFC composite Z score was calculated as follows: (1) the average scores from the four trials on the 9-HPT (the two trials for each hand were averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals were averaged); (2) the average scores of two 25-Foot Timed Walk trials; (3) the number correct from the PASAT-3. The MSFC is based on the concept that scores for these three dimensions-arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This was done by creating Z-scores for each component of the MSFC, and averaging them to create an overall composite Z score.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Total Volume in T2 Lesion
Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI).
Measured: 10 years
Change From Baseline in Total Volume of T2 Lesion
Total volume in T2 lesion was assessed by magnetic resonance imaging (MRI). A negative change from baseline indicates improvement.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Third Ventricle Diameter
Third ventricle diameter was assessed by MRI.
Measured: 10 years
Change From Baseline in Third Ventricle Diameter
Third ventricle diameter was assessed by MRI. A negative change from baseline indicates improvement.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Percentage Brain Volume Change (PBVC)
PVBC was assessed by MRI. A negative change from baseline indicates improvement.
Measured: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters
The correlation between FTY treatment duration and disability progression outcomes was assessed. The number presented in the table is the Pearson correlation coefficient, r.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Sclerosis, Relapsing Forms of Multiple SclerosisStudies 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 177 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
- NCT02307838
- Sponsor's protocol ID
- CFTY720D2201E2
- Acronym
- ACROSS
- Status last verified
- Feb 2017
- First submitted
- 14 May 2014
- Last updated
- 23 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow-up at 10 Years of Patients Enrolled in the Fingolimod Phase II Program in Relapsing Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT02307838
- Acronym / sponsor ID
- ACROSS / CFTY720D2201E2
- Keywords
- Multiple Sclerosis, MS, RRMS, relapsing forms of multiple sclerosis, fingolimod, FTY720, Gilenya
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Posted 23 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study collected follow-up data on approximately 90% of participants who were randomized and received one dose of study drug in FTY720D2201 (D2201). No study drug was given or required. Participants were required to be assessed at one or two visits, preferably at the original study site, but the option to be interviewed via phone or seen at home was provided. Information was gathered also on deceased participants. Assessments were performed only once within an 8 week period and included medical history, Multiple Sclerosis (MS) and Multiple Sclerosis Disease Modifying Therapy (MS DMT) history, Expanded Disability Status Scale (EDSS), Magnetic Resonance Imaging (MRI), and Multiple Sclerosis Functional Composite (MSFC).
Detailed description
This was a multicenter follow-up study of patients originally enrolled in the Phase 2 D2201 study. Patients did not receive any protocol specified treatment. The original D2201 study sites who agreed to participate in this study were required to locate their patients who were randomized in Study D2201 and asked them to return for a 10-year assessment, regardless of their current treatment status. Locating the patient may have required the use of search and advertising strategies to find those patients currently lost to follow-up, in accordance with local privacy legislation. Patients currently being followed within Study FTY720D2399 (NCT01201356) were asked to participate in Study FTY720D2201E2 and if patients gave consent, were enrolled concurrently in both studies.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase 2 CFTY720D2201 (NCT02307838) participants | Other | Other: Assessments armCFTY720D2201E2 participants did not receive any protocol specified treatment. The original D2201 study sites, who agreed to participate in this study, were required to locate their participants who were randomized in D2201 and asked them to return for a 10 year assessment, regardless of current treatment status. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Written informed consent must be obtained before any assessment is performed.
- Randomized in study FTY720D2201 and received at least one dose of study drug.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Assessments armProtocol required assessments not provided in standard of care | Other | Phase 2 CFTY720D2201 (NCT02307838) participants |
Primary outcome
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS)
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
EDSS is a scale for assessing neurologic impairment in MS. It consists of eight functional systems (FS) which are used to derive the EDSS steps (score) ranging from 0 (normal) to 10 (death due to MS). The functional systems are Visual, Brain Stem, Pyramidal, Cerebellar, Sensory, Bowel and Bladder, Cerebral and Other functions. Based on the assessment of each FS, the participant's score is determined between 0 to 10. A negative change from baseline indicates improvement.
16 secondary outcomes
Number of Participants With Disability Progression
Time frame: 10 Years
Number of Participants With EDSS <4 or <6
Time frame: 10 years
Number of Participants Not Using a Wheelchair or Being Bedridden
Time frame: 10 years
Number of Participants Classified as Secondary Progressive MS (SPMS)
Time frame: 10 years
Percentage of Participants With First Use of an Ambulatory Device
Time frame: 10 years
Percentage of Participants With First Use of a Wheelchair
Time frame: 10 years
Change From Baseline in Multiple Sclerosis Fuctional Composite (MSFC) Component: Nine Hole Peg Test (9-HPT)
Time frame: baseline from core study, CFTY720D2201 (NCT00333138), 10 years
Change From Baseline in MSFC Component: Paced Auditory Serial Addition Test (PASAT) Score
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Change From Baseline in MSFC Component: Timed 25-foot Walk Test Score
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Change From Baseline in Multiple Sclerosis Functional Composite (MSFC) Z Score
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Total Volume in T2 Lesion
Time frame: 10 years
Change From Baseline in Total Volume of T2 Lesion
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Third Ventricle Diameter
Time frame: 10 years
Change From Baseline in Third Ventricle Diameter
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Percentage Brain Volume Change (PBVC)
Time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years
Correlation Coeffcients Between FTY Treatment Duration and Disability Progression Parameters
Time frame: 10 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
26 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Assessments arm in people with Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis, run by Novartis Pharmaceuticals at 26 sites in 10 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 2 inclusion and 1 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Spain, Canada, Italy, Denmark, France and 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 23 Mar 2017). 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?
Change From Baseline (BL) in Expanded Disability Status Scale (EDSS) (time frame: baseline from core study (CFTY720D2201 (NCT00333138)), 10 years). 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 23 Mar 2017.