Relapsing Remitting Multiple SclerosisPhase 4EPOCNCT01534182
Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)
A Phase 4 study testing Fingolimod, Interferon beta - 1a (IFN) and Glatiramer acetate (GA) in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 26 sites in Russia.
Trial summary
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Relapsing Remitting Multiple Sclerosis
- What is being tested?
- Fingolimod, Interferon beta - 1a (IFN) and Glatiramer acetate (GA)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 26 sitesRussia
- Study dates
- Jan 2012to Jun 2013
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained before any assessment is performed.
- Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
- Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- Male or female patients aged 18-70 years.
- An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
- Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
- Naïve to treatment with fingolimod.
Who cannot join
- A manifestation of MS other than those defined in the inclusion criteria.
- A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
- History of malignancy of any organ system.
- Diagnosis of macular edema during Screening Phase.
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
- Patients who have received any live or live attenuated vaccines (including for varicella-zoster virus or measles) within 2 months prior to baseline.
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- Patients who have received total lymphoid irradiation or bone marrow transplantation.
- History of selected immune system treatments and/or medications.
- Any medically unstable condition, as assessed by the investigator.
- Selected cardiovascular, or hepatic conditions
- Selected abnormal laboratory values.
- Patients with any other disease or clinical condition (including neurologic or psychiatric disorders) which may affect patient enrollment into the study and study medication use by the Investigators' opinion.
- Participation in any clinical research study evaluating another not approved in Russia investigational drug or therapy within 6 months prior to baseline.
- History of hypersensitivity to the study drug or to drugs of similar chemical classes.
- Pregnant or nursing (lactating) women.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
Russia26 sites
Novartis Investigative Site
Arkhangelsk, Russia, 163045
Novartis Investigative Site
Barnaul, 656024
Novartis Investigative Site
Belgorod, 308007
Novartis Investigative Site
Kazan', 420021
Novartis Investigative Site
Kemerovo, 650066
Novartis Investigative Site
Khanty-Mansiysk, 628012
Novartis Investigative Site
Kirov, 610014
Novartis Investigative Site
Krasnodar, 350086
Novartis Investigative Site
Kursk, 305007
Novartis Investigative Site
Moscow, 119992
Novartis Investigative Site
Moscow, 127018
Novartis Investigative Site
N.Novgorod, 603126
Novartis Investigative Site
Nizhny Novgorod, 603076
Novartis Investigative Site
Nizhny Novgorod, 603155
Novartis Investigative Site
Novosibirsk, 630087
Novartis Investigative Site
Perm, 614990
Novartis Investigative Site
Saint Petersburg, 197376
Novartis Investigative Site
Saransk, 430032
Novartis Investigative Site
Saratov, 410030
Novartis Investigative Site
Smolensk, 214019
Novartis Investigative Site
Tomsk, 634050
Novartis Investigative Site
Tver', 170036
Novartis Investigative Site
Tyumen, 625048
Novartis Investigative Site
Ufa, 450000
Novartis Investigative Site
Ulyanovsk, 432063
Novartis Investigative Site
Yaroslavl, 150030
About this study
Official title: A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Being tested
- Fingolimod, Interferon beta - 1a (IFN), Glatiramer acetate (GA)
- Keywords
- Relapsing Remitting Multiple Sclerosis (RRMS), Fingolimod, Disease Modifying Therapy (DMT), TSQM-9
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Also called Gilenya
0.5 mg orally once a day
Interferon beta - 1a (IFN)Drug
Also called Rebif
44 mcg subcutaneously three times a week
Glatiramer acetate (GA)Drug
Also called Copaxone
20 mg subcutaneously once a day
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod | Experimental | Participants received 0.5 mg orally once a day. Receives: Drug: Fingolimod |
| Standard Disease Modifying Therapy (DMT) | Active comparator | Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day. Receives: Drug: Interferon beta - 1a (IFN); Drug: Glatiramer acetate (GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient-reported Treatment Satisfaction
The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
Measured: Baseline, 6 months
Secondary outcomes (4)
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Participants were monitored for adverse events, serious adverse events and death throughout the study.
Measured: 6 months
Changes in Patient-reported Effectiveness, Side Effects and Convenience
TSQM v 1.4 domains for effectiveness, side effects and convenience were used to evaluate this outcome. The effectiveness domain for items 1 - 3 was scored as: 1 (extremely dissatisfied) to 7 (extremely satisfied). For the side effects domain, item 4 scored as 0(no) or 1(yes); item 5 scored as 1 (extremely bothersome) to 5 (not at all bothersome); and items 6 - 8 scored as 1 (a great deal) to 5 (not at all). For the convenience domain, items 9 and 10 scored as 1(extremely difficult) to 7 (extremely easy), and item 11 scored as 1 (extremely inconvenient) to 7 (extremely convenient). For each domain, scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
Measured: Baseline, 6 months
Change in Patient-reported Depression
The Beck Depression Inventory (BDI-I) scale was used to measure this outcome. The scale consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. Each item was scored from 0 - 3. If more than one score was provided for an item, the maximum score was considered the item score. The total score was calculated as the sum of all individual items and then compared to a key to determine the depression's severity. The standard key ranges were: 0 - 9 indicated minimal depression; 10 - 18 indicated mild depression; 19 - 29 indicated moderate depression and 30 - 63 indicated severe depression. Higher total scores indicate more severe depressive symptoms.
Measured: Baseline, 6 months
Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)
The SF-36 is a health-related quality of life instrument used in numerous disease states, including MS (Brazier et al 1992). It is a self-administered survey that measures 8 domains of health including: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems and general mental health. Two summary scale scores can be calculated: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Each domain was scored by adding the individual items from the domain and transforming the resulting scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2013
- Study completionJun 2013
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 Relapsing Remitting 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 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
- NCT01534182
- Sponsor's protocol ID
- CFTY720DRU01
- Acronym
- EPOC
- Status last verified
- Aug 2014
- First submitted
- 8 Feb 2012
- Last updated
- 8 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (Fingolimod) 0.5 mg/Day in Patients With Relapsing Remitting Multiple Sclerosis Who Are Candidates for Multiple Sclerosis (MS) Therapy Change From Previous Disease Modifying Therapy (DMT)
- ClinicalTrials.gov ID
- NCT01534182
- Acronym / sponsor ID
- EPOC / CFTY720DRU01
- Conditions
- Relapsing Remitting Multiple Sclerosis
- Keywords
- Relapsing Remitting Multiple Sclerosis (RRMS), Fingolimod, Disease Modifying Therapy (DMT), TSQM-9
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 298 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Posted 8 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod | Experimental | Drug: FingolimodParticipants received 0.5 mg orally once a day. |
| Standard Disease Modifying Therapy (DMT) | Active comparator | Drug: Interferon beta - 1a (IFN), Drug: Glatiramer acetate (GA)Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent must be obtained before any assessment is performed.
- Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria (McDonald et al 2001, Polman et al 2005) (Appendix 2).
- Patients who explicitly agree to be assigned to a treatment group that may receive or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
- Male or female patients aged 18-70 years.
- An Expanded Disability Status Scale (EDSS) score of 0-6 inclusive.
Key exclusion criteria (16 listed)
- A manifestation of MS other than those defined in the inclusion criteria.
- A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
- History of malignancy of any organ system.
- Diagnosis of macular edema during Screening Phase.
- Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to have positive HIV antibody test.
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 |
|---|---|---|
| FingolimodAlso: Gilenya0.5 mg orally once a day | Drug | Fingolimod |
| Interferon beta - 1a (IFN)Also: Rebif44 mcg subcutaneously three times a week | Drug | Standard Disease Modifying Therapy (DMT) |
| Glatiramer acetate (GA)Also: Copaxone20 mg subcutaneously once a day | Drug | Standard Disease Modifying Therapy (DMT) |
Primary outcome
Change in Patient-reported Treatment Satisfaction
Time frame: Baseline, 6 months
The Treatment Satisfaction Questionnaire for Medication (TSQM) contains 14 items assessing the following 4 domains: effectiveness (items 1 - 3), side effects (items 4 - 8), convenience (items 9 - 11) and global satisfaction (items 12 - 14). The primary outcome was measured on the global satisfaction domain. Item 12 scored as 1 (not at all confident) to 5 (extremely confident); item 13 scored as 1 (not at all certain) to 5 (extremely certain); and item 14 scored as 1 (extremely dissatisfied) to 7 (extremely satisfied). Responses to items were summed and transformed: specifically, TSQM v 1.4 domain scale scores were computed by adding the items loading on each domain. The lowest possible score was subtracted from the composite score and divided by the greatest possible score range. This provided a transformed score between 0 and 1 that was then multiplied by 100. The final transformed score ranges from 0 to 100, with higher scores indicating better treatment satisfaction.
4 secondary outcomes
Number of Patients Who Experienced Adverse Events, Serious Adverse Events and Death
Time frame: 6 months
Changes in Patient-reported Effectiveness, Side Effects and Convenience
Time frame: Baseline, 6 months
Change in Patient-reported Depression
Time frame: Baseline, 6 months
Change in Patient-reported Health-related Quality-of-life Using the Short Form Health Survey v2 Acute (SF-36 v2 Acute)
Time frame: Baseline, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
- 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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fingolimod, Interferon beta - 1a (IFN) and Glatiramer acetate (GA) in people with Relapsing Remitting Multiple Sclerosis, run by Novartis Pharmaceuticals at 26 sites in Russia.
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 7 inclusion and 16 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 8 Aug 2014. 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 Russia. 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 8 Aug 2014). 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 in Patient-reported Treatment Satisfaction (time frame: Baseline, 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 8 Aug 2014.