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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT02618902
Eligibility Criteria:
Inclusion Criteria:
* MS according to 2010 revised McDonald criteria (76);
* Expanded disability status scale (EDSS) of 0-6.5 inclusive;
* Disease duration of maximum 15 years and first signs or symptoms at least 6 months prior to enrolment in the study;
* Active MS (relapsing and progressive): -1 relapse in the past year and/or
* at least 1 enhancing lesion on brain MRI in the past year
* new or enlarging T2 lesion(s) in comparison with a reference scan from maximum 1 year before
* Neurologically stable with no evidence of relapse for at least 30 days prior to start of screening and throughout during the screening phase;
* Positive T cell reactivity response to a mix of 7 myelin-derived peptides;
* Able to sign informed consent;
* Ability to comply with the protocol assessments;
* Appropriate venous access.
* Use of adequate contraceptive measures
Exclusion Criteria:
* Previous use of immunosuppressive or cytostatic treatment, including mitoxantrone, alemtuzumab or bone marrow transplantation or stem cell transplantation at any time prior to enrolment;
* Treatment with fingolimod or natalizumab or dimethylfumarate or teriflunomide within the last 3 months prior to study enrolment;
* Pregnancy or planning pregnancy in the next 12 months and breast feeding;
* Drug or alcohol abuse;
* Inability to undergo MRI assessments;
* History of or actual signs of immunodeficiency or malignancies;
* Concurrent clinically relevant cardiac, immunological, pulmonary, neurological, renal or other major disease;
* Hepatitis B, C, HIV, Syphilis or tuberculosis
* Splenectomy;
* Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that could interfere with the compliance to the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02618902
Study Brief:
Protocol Section:
NCT02618902