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 @ 2:11 PM
Ignite Modification Date:
2025-12-24 @ 2:11 PM
NCT ID:
NCT04062695
Eligibility Criteria:
Inclusion Criteria:
* Psoriatic Arthritis fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria
* chronic back pain \> 3 months
* BASDAI value ≥ 4 and backpain ≥ 4 / 10 VAS
* presence of active inflammation in Screening MRI of sacroiliac joints and / or spine (central reading)
* history of inadequate response to ≥ 2 NSAIDs or intolerance / contraindications
Exclusion Criteria:
* active current infection, severe infections in the last 3 months
* history of recurrent Herpes zoster or disseminated Herpes simplex
* immunodeficiency
* chronic Hepatitis B, C or HIV infection
* women: pregnant or lactating (have to practice reliable method of contraception)
* other severe diseases conflicting with a clinical study, contraindications for MRI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04062695
Study Brief:
Protocol Section:
NCT04062695