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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT01693393
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of a primary Sjögren´s Syndrome
* Liver values above 1,5 ULN
* uncontrolled arterial hypertension
* intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
* begin with Study medication
Exclusion Criteria:
* pre-treatment with Cyclosporine A
* Infection
* Neoplasia
* relevant cardiac, pulmonary, neurologic or psychiatric disease
* life-Vaccination within 4 weeks before begin with study medication
* pregnant or breast-feeding
* weight under 45kg or more than 110kg
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01693393
Study Brief:
Protocol Section:
NCT01693393