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:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04077957
Eligibility Criteria:
Inclusion Criteria:
* Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
* Patients 18 to 45 years of age.
* Proven AS according to the modified New York criteria.
* Acute phase of disease with ASDAS score ≥1.3.
* Ability to reconstitute the drug and self-inject it or have a person who can do so.
* Ability to store injectable test article at 2º to 8º C.
Exclusion Criteria:
* Patients with a history of active tuberculosis, hepatitis, gastrointestinal hemorrhage, tumors, infectious diseases or combined with other rheumaimmune systemic diseases or osteoarthritis diseases.
* Pregnancy/lactation.
* Receipt of any live (attenuated) vaccines within 4 weeks before the screening visit.
* Significant concurrent medical diseases including uncompensated congestive heart failure (NYHA III-IV), myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection.
* Participation in trials of other investigational medications within 30 days of entering the study.
* Clinical examination showing significant abnormalities of clinical relevance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04077957
Study Brief:
Protocol Section:
NCT04077957