Relapsing Multiple SclerosisPhase 3NCT01199861
Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)
A Phase 3 study testing Fingolimod, Seasonal influenza vaccine and Tetanus toxoid vaccine in people with Relapsing Multiple Sclerosis, run by Novartis at 25 sites in 9 countries.
Trial summary
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Relapsing Multiple Sclerosis
- What is being tested?
- Fingolimod, Seasonal influenza vaccine and Tetanus toxoid vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 25 sitesin 9 countries
- Study dates
- Aug 2010to May 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have relapsing MS
- Must have lifetime tetanus vaccination
- Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
Who cannot join
- Patients with a type of MS that is not relapsing
- Patients with history of chronic immune disease
- Certain cancers
- Diabetic patients with certain eye disorders
- Patients who are on certain immunosuppressive medications or heart medications
- Patients with certain heart conditions
Show all 9Show fewer
- Patients with certain lung conditions
- Patients who have already received the 2010/2011 seasonal influenza vaccine
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
Belgium5 sites
Novartis Investigative Site
Aalst, 9300
Novartis Investigative Site
Brussels, 1200
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Liège, 4000
Novartis Investigative Site
Wilrijk, 2610
France4 sites
Novartis Investigative Site
Caen, 14033
Novartis Investigative Site
Rennes, 35043
Novartis Investigative Site
Saint-Herblain, 44800
Novartis Investigative Site
Toulouse, 31059
Spain4 sites
Novartis Investigative Site
Madrid, 28029
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Seville, 41009
Novartis Investigative Site
Valencia, 46009
Canada3 sites
Novartis Investigative Site
Montreal, Quebec, H3A 2B4
Novartis Investigative Site
Nepean, Ontario, K2G 6E2
Novartis Investigative Site
Sherbrooke, JiH 5N4
Finland2 sites
Novartis Investigative Site
Seinäjoki, 60220
Novartis Investigative Site
Turku, 20100
Guatemala2 sites
Novartis Investigative Site
Guatemala City, 01010
Novartis Investigative Site
Guatemala City, 01014
Poland2 sites
Novartis Investigative Site
Katowice, 40-594
Novartis Investigative Site
Lodz, 90-153
United Kingdom2 sites
Novartis Investigative Site
Nottingham, NG7 2UH
Novartis Investigative Site
Stoke-on-Trent, ST4 7LN
About this study
Official title: A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.
- Conditions
- Relapsing Multiple Sclerosis
- Being tested
- Fingolimod, Placebo, Seasonal influenza vaccine, Tetanus toxoid vaccine
- Keywords
- Relapsing multiple sclerosis, MS, Immune response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingolimodDrug
Also called FTY720
Fingolimod 0.5 mg capsules for oral administration.
PlaceboDrug
Matching placebo capsules for oral administration.
Seasonal influenza vaccineBiological
Also called Agrippal (TM)
Commercially available injectable influenza vaccine for the 2010/11 influenza season.
Tetanus toxoid vaccineBiological
Also called Tetanol (TM)
Commercially available tetanus toxoid vaccine booster injection.
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod | Experimental | Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Receives: Drug: Fingolimod; Biological: Seasonal influenza vaccine; Biological: Tetanus toxoid vaccine |
| Placebo | Placebo comparator | Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. Receives: Drug: Placebo; Biological: Seasonal influenza vaccine; Biological: Tetanus toxoid vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune Response 3 Weeks After Seasonal Influenza Vaccination
Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
- Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.
- Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.
Measured: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
Secondary outcomes (6)
Immune Response 6 Weeks After Seasonal Influenza Vaccination
Percentage of participants who responded to treatment with the seasonal influenza vaccine 6 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
- Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40.
- Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.
Measured: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
Immune Response 3 Weeks After Tetanus Toxoid Booster
Percentage of participants with an immune response to a single dose of tetanus toxoid three weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:
- Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
- Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.
Measured: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
Immune Response 6 Weeks After Tetanus Toxoid Booster
Percentage of participants with an immune response to a single dose of tetanus toxoid six weeks after vaccination. A patient was considered a responder to tetanus toxoid booster vaccination if one of the following criteria was met:
- Seroconversion: The pre-vaccination antibody titer measurement was <0.1 IU/ml and the post-vaccination measurement was ≥0.4 IU/ml.
- Significant increase: The pre-vaccination antibody titer measurement was ≥0.1 IU/ml and the increase in antibody titer from this to the post-vaccination measurement was ≥4- fold.
Measured: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)
Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination
Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo three weeks after a single dose of seasonal influenza vaccine.
Measured: Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).
Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination
Change from Baseline was expressed by the ratio of post-vaccination to pre-vaccination antibody titer for each of the three strains included in the seasonal influenza vaccine. Inhibition of an immune response to each strain included in the seasonal influenza vaccine was assessed by the relative difference of the geometric mean antibody titer ratio on fingolimod as compared to placebo six weeks after a single dose of seasonal influenza vaccine.
Measured: Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
Number of Participants With Adverse Events (AEs)
Relationship to study drug was determined by the investigator (suspected/not suspected).
A serious AE is defined as an event which fulfills one of the following criteria:
- is fatal or life-threatening;
- results in persistent or significant disability/incapacity;
- constitutes a congenital anomaly/birth defect;
- requires inpatient hospitalization or prolongation of existing hospitalization;
- is medically significant, i.e., jeopardizes the patient or may require intervention to prevent one of the outcomes listed above.
Measured: From first dose of study drug until 45 days after the last dose of study drug (130 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionMay 2011
- Study completionMay 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 Relapsing 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, Investigator, Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199861
- Sponsor's protocol ID
- CFTY720D2320
- Other IDs
- 2010-019028-30
- Status last verified
- May 2012
- First submitted
- 9 Sep 2010
- Last updated
- 19 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-month Blinded, Randomized, Multicenter, Placebo-controlled Study to Evaluate the Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Influenza Vaccination and Tetanus Toxoid Booster Injection in Patients With Relapsing Forms of Multiple Sclerosis (MS)
- ClinicalTrials.gov ID
- NCT01199861
- Acronym / sponsor ID
- CFTY720D2320
- Conditions
- Relapsing Multiple Sclerosis
- Keywords
- Relapsing multiple sclerosis, MS, Immune response
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 19 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod | Experimental | Drug: Fingolimod, Biological: Seasonal influenza vaccine, Biological: Tetanus toxoid vaccineParticipants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. |
| Placebo | Placebo comparator | Drug: Placebo, Biological: Seasonal influenza vaccine, Biological: Tetanus toxoid vaccineParticipants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must have relapsing MS
- Must have lifetime tetanus vaccination
- Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
Key exclusion criteria (9 listed)
- Patients with a type of MS that is not relapsing
- Patients with history of chronic immune disease
- Certain cancers
- Diabetic patients with certain eye disorders
- Patients who are on certain immunosuppressive medications or heart medications
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: FTY720Fingolimod 0.5 mg capsules for oral administration. | Drug | Fingolimod |
| PlaceboMatching placebo capsules for oral administration. | Drug | Placebo |
| Seasonal influenza vaccineAlso: Agrippal (TM)Commercially available injectable influenza vaccine for the 2010/11 influenza season. | Biological | Fingolimod, Placebo |
| Tetanus toxoid vaccineAlso: Tetanol (TM)Commercially available tetanus toxoid vaccine booster injection. | Biological | Fingolimod, Placebo |
Primary outcome
Immune Response 3 Weeks After Seasonal Influenza Vaccination
Time frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
Percentage of participants who responded to treatment with the seasonal influenza vaccine 3 weeks after vaccination. Response was defined as patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine: * Seroconversion: The pre-vaccination antibody titer measurement was <1:10 and the post-vaccination measurement is ≥1:40. * Significant increase in antibody titer: The pre-vaccination antibody titer measurement was ≥1:10 and the increase in antibody titer from this to the post-vaccination measurement is ≥ 4-fold.
6 secondary outcomes
Immune Response 6 Weeks After Seasonal Influenza Vaccination
Time frame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
Immune Response 3 Weeks After Tetanus Toxoid Booster
Time frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
Immune Response 6 Weeks After Tetanus Toxoid Booster
Time frame: Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)
Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination
Time frame: Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).
Change From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination
Time frame: Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
Number of Participants With Adverse Events (AEs)
Time frame: From first dose of study drug until 45 days after the last dose of study drug (130 days).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- 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
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fingolimod, Seasonal influenza vaccine and Tetanus toxoid vaccine in people with Relapsing Multiple Sclerosis, run by Novartis at 25 sites in 9 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 3 inclusion and 9 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 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Belgium, France, Spain, Canada, Finland and 4 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. 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?
Yes. Results are posted in the registry (first posted 19 Jun 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?
Immune Response 3 Weeks After Seasonal Influenza Vaccination (time frame: Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)). 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 19 Jun 2012.