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 study is to find out the safety and effectiveness of Avonex (interferon-beta-1a) Therapy in patients who have developed neutralizing antibodies during previous interferon-beta treatment
This is a multi-centre, prospective, open label, non-comparative phase IV trial. Eligible patients will receive treatment with IFN-beta-1a AVONEX® 30 mcg i.m. once weekly for 12 months.The patients will be examined clinically and NAb titres will be performed at screening and after 12 months. Adverse event source verification will be performed during the documentation period.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low immunogenic interferon-beta-1a | Drug | dosage and frequency as per Biogen Idec protocol |
|
| Measure | Description | Time Frame |
|---|---|---|
| neutralizing antibody levels will be followed | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with NAb positive titre > 20. | 12 months | |
| Relative change from baseline (screening) of NAb titre | 12 months | |
| Change in the annualised relapse rate and number of relapse-free (total and documented relapses) patients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Biogen-Idec Investigator | neurologyclinicaltrials@biogenidec.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Gothenburg | 416 85 | Sweden | |||
| Coordinating 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 |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 months and as needed for relapses |
| The percentage of patients with a loss of disability of 1.0 (or more) score on the EDSS. | 12 months |
| Huddinge |
| Sweden |
| Research Site | Jönköping | 551 85 | Sweden |
| Research Site | Karlstad | 651 85 | Sweden |
| Research Site | Stockholm | 141 86 | Sweden |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D036341 |
| Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |