Relapsing Remitting Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Avonex, Interferon beta-1a
Brief summary
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
Detailed description
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.
Interventions
DRUGInterferon beta-1a
IM injection
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Relapsing Remitting Multiple Sclerosis * Interferon naïve * Eligible for interferon beta-1a (AVONEX®) therapy as per Summary of Product Characteristics: * Subject has had relapsing MS for \> 1 year * Subject has had experienced 2 exacerbations in the last 2 years * Subject had an EDSS \[5\] score of \< 5.5 * Subject was ambulant
Exclusion criteria
* Diagnosis of MS defined as progressive * History of any significant cardiac, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude therapy with interferon beta * History of severe allergic or anaphylactic reactions or history of hypersensitivity to human albumin * History of seizures within the 3 months prior to starting this study * History of intolerance to acetaminophen (paracetamol), ibuprofen, naproxen or other NSAIDs, that would preclude use of at least one of these during the study * History of intolerance to interferons * Previous use of interferon beta * Female subjects who were pregnant or breast-feeding * For female subjects, unless postmenopausal or surgically sterile, unwillingness to practice effective contraception
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| EDSS score throughout the study | screening, Day -1, Months 12 and 24 |
Countries
Belgium, Luxembourg, United Kingdom
Outcome results
None listed