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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT05031767
Eligibility Criteria:
Inclusion Criteria:
* Male or non-pregnant, non-nursing female \>18 years of age at screening
* Patients with a diagnosis of axSpA who fulfil the diagnostic Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
* Stable medical treatment with TNFi the last 6 months
* Low disease activity (ASDAS\<2.1) at inclusion
* Capable of understanding the Norwegian language and of signing an informed consent form
Exclusion Criteria:
Medical conditions:
* Major co-morbidities, such as severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease (NYHA class III or IV), severe respiratory diseases, and/or cirrhosis.
* Indications of active tuberculosis (TB)
Diagnostic assessments:
* Abnormal renal function, defined as serum creatinine \>142 µmol/L in female and \>168 µmol/L in male, or glomerular filtration rate (GFR) \<40 mL/min/1.73 m2
* Abnormal liver function (defined as Alanine Transaminase (ALT) \>3x upper normal limit), active or recent hepatitis
* Leukopenia and/or thrombocytopenia
Other:
* Pregnancy and/or breastfeeding (current at screening or planned within the duration of the study)
* Severe psychiatric or mental disorders, alcohol abuse or other substance abuse, language barriers or other factors which makes adherence to the study protocol impossible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05031767
Study Brief:
Protocol Section:
NCT05031767