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 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT00939003
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with inadequate response to \>/= 1 non-steroidal anti-inflammatory drugs (NSAIDs)
* Chronic back pain with onset \< 45 years of age
* Magnetic resonance imaging (MRI) indicating active sacroiliitis or positive human leukocyte antigen-B27 (HLA-B27) blood test in addition to meeting spondyloarthritis clinical criteria
* Negative purified protein derivative (PPD) test and chest x-ray performed at Baseline visit must be negative
* Ability to administer subcutaneous injections
* General good health otherwise
Exclusion Criteria:
* Prior anti-tumor necrosis factor (TNF) therapy
* Psoriasis or psoriatic arthritis
* Fulfillment of modified New York criteria for ankylosing spondylitis
* Recent infection requiring treatment
* Significant medical events or conditions that may put patients at risk for participation
* Females who are pregnant or breast-feeding or considering becoming pregnant during the study
* History of cancer, except successfully treated skin cancer
* Recent history of drug or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00939003
Study Brief:
Protocol Section:
NCT00939003