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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT00244166
Eligibility Criteria:
Inclusion Criteria:
1. ankylosing spondylitis according to the modified NY criteria 1984
2. age between 18 and 70 years
3. insufficient response to therapy with NSAIDs
4. BASDAI \> 4
5. Previous therapy with DMARDs (such as sulfasalazine, methotrexate etc.) or steroids less than or equal to 7,5mg is allowed, should be discontinued or stable 4 weeks before study start
6. written informed consent
Exclusion Criteria:
1. Pregnancy or lactation
2. current severe infection or during the last 3 months
3. suspected opportunistic infection during the past 2 months (such as Herpes zoster, cytomegaly-, Pneumocystis carinii-infection), HIV-infection
4. Malignancies
5. severe cardial, renal, hematological, endocrinological, pulmonal, gastrointestinal (such as peptic ulcers) neurological, hepatic (viral or toxic hepatitis) concomitant disease, uncontrolled arterial hypertension remitting thrombosis, embolism
6. Diabetes mellitus or increased blood glucose test
7. uncontrolled glaucoma
8. active immunization during the past 2 weeks or planned for the next 8 weeks
9. pathologic laboratory test results: creatinine \>200 µmol/l, liver enzymes \> 2,5 fold, AP \>2,5 fold upper normal ranges
10. significant pathological changes during physical examination
11. clinical trial participation during the past 30 days before screening
12. intake of "hard drugs" (such as cocaine, heroin)
13. therapy with more than 7,5 mg prednisolone, intraarticular steroids during the past 4 weeks before study start
14. current application for retirement
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00244166
Study Brief:
Protocol Section:
NCT00244166