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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT01144351
Eligibility Criteria:
Inclusion Criteria:
* Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years
* Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year
* Has had an inadequate response or intolerability to interferon and/or glatiramer acetate
* Is able and willing to undergo Gd administration and repeat MRI testing
Exclusion Criteria:
* Has primary progressive MS (PPMS)
* Any history of treatment with recombinant humanized monoclonal antibodies
* Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline
* A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline
* Any history of congestive heart failure or currently has a pacemaker
* Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug
* Has any medical history or psychiatric condition that would impact outcome or study participation
* Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01144351
Study Brief:
Protocol Section:
NCT01144351