Multiple Sclerosis
Conditions
Brief summary
This is a cross sectional Phase 4, multicenter, study of AVONEX® and JUMTAB® to determine the frequency of IFN induced Neutralizing Antibodies (Nabs). A secondary component is the long term retrospective observational evaluation conducted to measure efficacy, adherence to therapy, tolerability, and safety in subjects with relapsing MS related to antibody status and treatment.
Detailed description
The primary objective of this study is to evaluate the frequency of neutralizing antibodies in patients treated with IFN beta 1a IM (Avonex) and IFN beta 1a IM biosimilar formulation (Jumtab). Secondary objectives: * Evaluate the effect of Nabs on the severity of the relapses on each treatment group, measured by: * The need and duration of steroid courses * The need and duration for hospitalization. * To evaluate the safety and tolerability of the IFN beta 1a IM treatments \[Avonex and Jumtab\]. * To identify the genetic profile of the patients with relation to the predisposition to Nab development (HLA DR4 (in particular HLADRB1\* 0401 and 0408) and DR16 (in particular HLADRB1\* 1601) * At selected sites: To evaluate the influence of the interferon and the Nabs on the activation of neopterin
Interventions
OTHERclinical and neurological evaluation
The day of the usual IFN beta 1a IM injection
OTHERBlood Sample
For evaluation of interferon-related Nab
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection: * No limitation of age, EDSS or other disease parameters will be applied. * Subject with MS * Subjects treated with IFN beta 1a IM (Avonex) or the biosimilar formulation of IFN beta 1a IM (Jumtab) in line with the local prescription information * The IFN beta 1a IM (Avonex or Jumtab) treatment should be the first disease modifying treatment * The subject should be treated with the same drug for at least 18 months and up to a maximum of 3 years
Exclusion criteria
* Candidates will be excluded from study entry if any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibodies to Interferon beta 1a IM (Avonex) or IFN beta 1a IM biosimilar | Day 1 |
| Percentage of patients with interferon induced Nabs measured in luciferase test | Day 1 |
| neutralizing antibodies to IFN beta 1a IM (Avonex) or IFN beta 1a IM biosimilar formulation (Jumtab) | 1 day |
| Percent of patients with interferon induced neutralizing antibodies measured in a luciferase test | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Genetic profile of population with relation to predisposition to Nab generation | Day 1 |
| Rate/ duration of corticosteroid use for relapse | measured up to 3 years prior to enrollment @ Day 1 |
| Rate and duration of corticosteroid use for relapse | Day 1 |
| Genetic profile of patients with relation to the predisposition to Nab development | 1 day |
| Interferon activity will be tested by neopterin protein activation before and after injection | 48-72 hours |
| Need/ duration of hospitalization for relapse | measured up to 3 years prior to enrollment @ Day 1 |
| Need and duration of hospitalization for relapse | Day 1 |
| Genetic profile of patients with relation to their predisposition to Nab development | Day 1 |
| The interferon activity will be tested by neopterin protein activation (level before IFNbeta1a IM injection and 48 hours after the injection) | twice measured: - Day 1 before IFN injection - 48-72hours after the IFN injection |
Countries
Colombia, Mexico
Outcome results
None listed