Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a? (FLAIR)

Biogen

Status and phase: Completed; Phase 4

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Drug: Interferon beta-1a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534261

BIO-BNL 99-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 284 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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284 participants in 1 patient group

1

Experimental group

Description:

patients received Avonex IM injections and be evaluated for quality of life criteria

Treatment:

Drug: Interferon beta-1a