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 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
NCT ID:
NCT01040195
Eligibility Criteria:
Inclusion Criteria:
* Patients who fulfilled criteria for the diagnosis of Ankylosing Spondylitis (Modified New York Criteria) or undifferentiated spondyloarthropathy (UspA) (Amor criteria) and are within 8 years of disease onset with:
* Inflammatory back Pain of more than 6 months
* BASDAI ≥4 or EMS ≥45 minutes
* Have failed maximum dose of at least one NSAID for 6 weeks.
Exclusion Criteria:
* Patients with renal diseases
* patients with hepatic diseases
* Patients with severe uncorrected anemia (Hb\<7gm)
* Patients previously received full dose of sulfasalazine and/or methotrexate with inadequate relief
* Pregnant or lactating females
* Malignancy or active infection
* Patient requiring and affording biologicals
* Patients who have received steroids in the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01040195
Study Brief:
Protocol Section:
NCT01040195