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:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT01435993
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with a relapsing form of MS .
* Using one of the following ongoing MS treatment strategies, defined as
1. Currently receiving Beta-interferon/Copaxone for treatment of MS and have been receiving the current course of therapy for 3 or more months prior to screening, OR
2. Not currently receiving disease modifying therapies for treatment of MS, and has not received such therapies for at least 3 months prior to screening.
* Demonstrated clinical activity in 2 years prior to screening, whilst receiving current/previous treatment regimen or prior to any treatment regimen
* Expanded Disability Status Scale (EDSS) score ≤6.0 at either the screening or baseline visit.
* Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent.
* Body weight equal to or greater than: 50 kilogrammes
Exclusion Criteria:
* Complications/History of other diseases that may impact on safety of patients enroling into the study.
* Liver function test outside normal range for patient population
* Treatment with methylprednisolone or any other systemic steroid, for a relapse or otherwise, within 30 days of screening
* Treatment in the past 6 months with any of the following agents: Fingolimod (Gilenya), methotrexate, mitoxantrone, azathioprine, or other small molecule immunosuppressants.
* History of anaphilaxis to protein based therapeutics or mono-clonal antibodies.
* Positive result for Hapatitis B, HIV, and/or drugs of abuse, or excessive alcohol consumption.
* Not able to undergo MRI scanning safely, or Gadolinium (contrast enhancing agents) during MRI.
* Other significant infections e.g. Tuberculosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01435993
Study Brief:
Protocol Section:
NCT01435993