Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:31 PM
Ignite Modification Date:
2025-12-24 @ 12:31 PM
NCT ID:
NCT00534261
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00534261
Study Brief:
Protocol Section:
NCT00534261