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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00243750
Eligibility Criteria:
Inclusion criteria:
* Definite ankylosing spondylitis according to the New York criteria of 1984.
* Known ankylosing spondylitis according to the modified New York criteria from 1984
* age 18- 70 years
* insufficient therapy with nonsteroidal antirheumatic drugs
* BASDAI \> 4
* therapy with DMARD (sulfasalazine, hydroxychloroquine, leflunomide, methotrexate ≤ 10 mg etc.) allowed before study start if discontinued at least 1 month before study start; elimination of leflunomide with colestyramin of coal if necessary. · therapy with biologics (TNF-alpha blocking agents, IL-1-blocking agents etc.) discontinued at least 3 months before study start
* therapy with steroids ≤ 10 mg at least 4 weeks stable before study start
* patient should be willing to prevent pregnancy by using accepted contraceptive methods until the end of study
* signed informed consent
* patient should be able to administer study drug
* exclusion of pregnancy in female patients with childbearing potential
Exclusion criteria:
* intake of glucocorticosteroids of \> 10 mg, therapy with intraarticular steroids within last 4 weeks before study start
* previous therapy with methotrexate \> 10 mg
* allergy to methotrexate or parts of medication
* pregnancy/ lactation
* current severe infections, suspicion for opportunistic infections (Herpes zoster, cytomegaly-, pneumocystis carinii-infection) or within the last 4 months , HIV- infection
* malignant disease within the last 5 years
* severe cardiac, renal, hematologic, endocrine, pulmonary, neurological, gastrointestinal (e.g. gastroesophageal ulcer) or hepatic (viral hepatitis, toxic liver disease etc.) disease, uncontrolled high blood pressure, recurrent thrombosis/ emboly, significant disease in hematopoesis.
* active immunization within last 4 weeks or immunization which is planned for study time
* significant findings in the laboratory: hemoglobin \< 8,5 mg/dl, leukopenia \< 3,5 /nl, thrombopenia\< 100 /nl, creatinine\>200 µmol/l, liver enzymes or alkaline phosphate \> 1,5-fold over upper limit of normal
* significant pathologic findings in physical examination
* particpation in another clinical trial in last 30 days
* substance abuse, e.g. cocaine, heroine, alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00243750
Study Brief:
Protocol Section:
NCT00243750