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This study was to find out if patients with Relapsing Remitting Multiple Sclerosis treated with Interferon beta-1a had an improved quality of life after treatment with Interferon beta-1a
The study was an open-label, multi-center, international post-marketing study (phase 4). Eligible patients were interferon naïve patients suffering from relapsing MS. The duration of a subject's participation in the study was up to a maximum 26 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | patients received Avonex IM injections and be evaluated for quality of life criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interferon beta-1a | Drug | IM injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate the correlation between the MS Functional Composite Index and two Quality of Life scales (MS Quality of Life 54 and AMS Quality of Life) in patients treated with interferon beta-1a (AVONEX®). | screening, Day -30, Day -1, Months 3, 6, 12, 18, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Reproducibility of Quality of Life scales per language version | months 18 and 24 | |
| Reliability of the Quality of Life scales per language version | months 18 and 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biogen-Idec Investigator | neurologyclinicaltrials@biogenidec.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coordinating Research Site | Sijsele-Damme | 8340 | Belgium | |||
| Coordinating Research Site |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000068556 | Interferon beta-1a |
| ID | Term |
|---|---|
| D016899 | Interferon-beta |
| D007370 | Interferon Type I |
| D007372 | Interferons |
| D016207 | Cytokines |
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| EDSS score throughout the study |
| screening, Day -1, Months 12 and 24 |
| Esch-sur-Alzette |
| 4011 |
| Luxembourg |
| Coordinating Research Site | Glasgow | Scotland | United Kingdom |
| 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 |