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 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT04507659
Eligibility Criteria:
Inclusion Criteria:
* Age 18-65, both gender;
* Active Ankylosing Spondylitis;
* Participants who have been treated with non-steroidal anti-inflammatory drugs(NSAIDs) and still have active disease, or Participants who are intolerant to NSAIDs and stop the drug;
* Participants receiving low-dose oral glucocorticoid therapy (≤10mg/d prednisone) should maintain a stable medication regimen for at least 4 weeks before the first dose of this study. Do not adjust the dose during the entire study period except in emergency situations.
* Participants receiving other non-prohibited co-drugs should maintain a stable medication regimen for at least 7 days before the first dose of this study;
* Understand and voluntarily signed informed consent.
Exclusion Criteria:
* A history of known or suspected complete spinal rigidity, or clinical and imaging confirmed complete spinal rigidity;
* A history of any other autoimmune rheumatic disease;
* Any history of joint prosthesis infection, and the prosthesis is still in place;
* Participants who are using strong opioid analgesics (such as methadone, hydromorphone, morphine, etc.);
* Participants who have been treated with any JAK inhibitors (such as Tofacitinib, Baricitinib, Ruxolitinib, Filgotinib, Upadacitinib, etc.);
* Participants who have drug abuse or alcohol dependence;
* Participants who have had herpes virus infection in the past month;
* Participants who have a history of venous thrombosis (regardless of current treatment);
* Any significant clinical and laboratory abnormalities that the investigator believes will affect the safety evaluator；
* Participants who cannot be treated and followed up according to the trial protocol;
* Any Participant considered by the investigator to be unsuitable to participate in this clinical study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04507659
Study Brief:
Protocol Section:
NCT04507659