Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Avonex | Active Comparator | Approximately 90 subjects treated with IFN beta 1a IM 30μg |
|
| Group 2 Jumtab | Active Comparator | Approximately 90 subjects treated with IFN beta 1a IM biosimilar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clinical and neurological evaluation | Other | The day of the usual IFN beta 1a IM injection |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate and duration of corticosteroid use for relapse | Day 1 | |
| Need and duration of hospitalization for relapse | Day 1 | |
| Genetic profile of patients with relation to their predisposition to Nab development |
Not provided
Inclusion Criteria:
To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of selection:
Exclusion Criteria:
Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of selection:
NOTE: subjects may receive investigational symptomatic therapies for MS at any time prior to evaluation period.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bogotá | Colombia | ||||
| Research Site |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Blood Sample | Other | For evaluation of interferon-related Nab |
|
| Blood Sample | Genetic | genetic evaluation - predisposition to Nab generation |
|
| 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 |
| 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 |
| Need/ duration of hospitalization for relapse | measured up to 3 years prior to enrollment @ 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 |
| León |
| Guanajuato |
| Mexico |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |