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 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT01934933
Eligibility Criteria:
Inclusion Criteria:
* 18 to 65 years
* Meet 1984 NewYork modified criteria for AS
* BASDAI≥4 or ASDAS score ≥ 2.1
* CRP\>6 mg/L or ESR\>28 mm/h
* Syndesmophyte quantity ≥2 and \<16 of spine
* Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception
* No active or latent tuberculosis infection.
Exclusion Criteria:
* Pregnant or breastfeeding women
* current or previous history of psoriasis or inflammatory bowel disease.
* infection with clinical significance within 24 weeks before screening
* receipt any bio-agents treatment within 12 weeks before screening
* corticosteroids intra-articular injections in last 3 months before the trial
* Significant concurrent medical events including: Gastrointestinal ulcer, myocardial infarction within 12 months before the screening visit, unstable angina pectoris, congestive heart failure.
* Alcohol and drug abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01934933
Study Brief:
Protocol Section:
NCT01934933