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 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT03933202
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)
* Have time since diagnosis of RMS of at least 12 months
* In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets
* Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD
* Have decided to initiate treatment with cladribine tablets during routine clinical care
* Meet criteria as per the approved USPI
* Have access to a valid e-mail address
Exclusion Criteria:
* Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral)
* Transitioning from previous oral DMD solely for administrative reasons such as relocation
* Have comorbid conditions that preclude participation
* Have any clinical condition or medical history noted as contraindication on USPI
* Are currently participating in an interventional clinical trial
* Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03933202
Study Brief:
Protocol Section:
NCT03933202