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 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT03211793
Eligibility Criteria:
Inclusion Criteria:
* Established diagnosis of SSc according to the 2013 ACR/EULAR criteria
* At least one active digital ulcer (painful area, \>2 mm in diameter with visible depth and loss of dermis) refractory to intravenous prostacyclins
* 'Refractory to prostacyclins' is defined as
* Worsening of ulcer(s) within 1 month after prostacyclins iv
* No improvement of ulcer(s) after 2 months after prostacyclins iv, as judged by the referring physician
* Recurrence of exactly the same ulcer(s) (same location) within 3 months after prostacyclins iv
* Written informed consent
Exclusion Criteria:
* Ulcer with underlying calcinosis (ruled out by X-ray prior to screening/inclusion)
* History of neoplasm or malignancy in the past 10 years
* Pregnancy or unwillingness to use adequate contraception during study
* Serious known concomitant disease with life expectancy \<1 year
* Uncontrolled hypertension
* Uncontrolled acute or chronic infection with systemic symptoms (e.g. fever)
* Follow-up impossible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03211793
Study Brief:
Protocol Section:
NCT03211793