Effect of Treatment With Fingolimod on the Immune Response Following S
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)
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
Placebo
- Placebo
Given to everyone in the trial
- Seasonal influenza vaccine
- Tetanus toxoid vaccine
Results by group
Immune Response 3 Weeks After Seasonal Influenza Vaccination
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Fingolimod | 53.3 percentage of participants | 90 | |
| Placebo | 83.7 percentage of participants | 43 |
Fingolimod
Placebo
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Fingolimod | 95 | 1 (1.1%) | |
| Placebo | 43 | 2 (4.7%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Immune Response 3 Weeks After Seasonal Influenza Vaccination
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study week 9)
Immune responseThe primary variable is the responder rate to the seasonal influenza vaccine at Visit 7. The responder rate is defined as the proportion of patients fulfilling one of the following criteria for at least one of the three strains contained in the seasonal influenza vaccine:
Other measures (6)
Immune Response 6 Weeks After Seasonal Influenza Vaccination
Week 6 (pre-vaccination) and 6 weeks after vaccination (Study week 12).
Immune responseImmune Response 3 Weeks After Tetanus Toxoid Booster
Week 6 (pre-vaccination) and 3 weeks after vaccination (Study Week 9)
Immune responseImmune Response 6 Weeks After Tetanus Toxoid Booster
Week 6 (pre-vaccination) and 6 weeks after vaccination (Study Week 12)
Immune responseChange From Baseline in Seasonal Influenza Vaccine Antibody-titer 3 Weeks After Vaccination
Pre-vaccination (Week 6) and 3 weeks after vaccination (Study Week 9).
Immune responseChange From Baseline in Seasonal Influenza Vaccine Antibody-titer 6 Weeks After Vaccination
Pre-vaccination (Week 6) and 6 weeks after vaccination (Study Week 12).
Immune responseNumber of Participants With Adverse Events (AEs)
From first dose of study drug until 45 days after the last dose of study drug (130 days).
Safety
Who could take part
Relapsing MS · 18 to 55
Show the full criteria
Inclusion criteria
* Must have relapsing MS * Must have lifetime tetanus vaccination * Agree to receive 2010/2011 seasonal influenza vaccine and tetanus toxoid booster injection
Exclusion criteria
* 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 * Patients with certain lung conditions * Patients who have already received the 2010/2011 seasonal influenza vaccine Other protocol-defined inclusion/exclusion criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Aug 2010
Main results due
May 2011
Finished
May 2011
Results posted
Jun 2012