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:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT04645420
Eligibility Criteria:
Inclusion Criteria:
Patients who meet ALL the following criteria can be enrolled:
* Patient must be able to understand and communicate with the investigator and comply with the requirements of the study and must give a written, signed and dated informed consent before any study assessment is performed.
* Male or non-pregnant, non-nursing female patients at least 18 years of age.
* With a diagnosis of active PsA according to CASPAR criteria
* Naïve to csDMARD and bDMARD,
* At least 1 swollen joint at screening or baseline (despite NSAIDs therapy) with ability to perform a synovial biopsy at W0.
* Concomitant oral steroids (no more than 10 mg/day of prednisolone), NSAIDs, or painkillers is permitted if started prior to the study and remain at a stable dose at least 4 weeks before the baseline.
* Allowed concomitant medications are to remain stable through week 24.
* At least one joint (small or large) to biopsy in order to get synovial tissue. Small joints must have an US scoring \> 2 on grey-scale score/power Doppler.
Exclusion Criteria:
Patients who meet AT LEAST one of the following exclusion criteria will be excluded:
* Contraindications for needle-arthroscopy.
* Patients with hypersensitivity to apremilast or to one of its excipients
* Prior csDMARD or bDMARD therapy,
* Women who are pregnant, breastfeeding or planning on becoming pregnant for the 24 weeks of the drug administration,
* Non-menopausal women who are not using an adequate contraception method,
* Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
* Impossibility to meet specific protocol requirements (e.g. blood sampling)
* Patient is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
* Uncooperative or any condition that could make the patient potentially noncompliant to the study procedures
* Any therapy by intra-articular injections (e.g. corticosteroid) within 4 weeks before baseline.
* Any intramuscular corticosteroid injection within 4 weeks before baseline.
* A history of active tuberculosis (TB).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04645420
Study Brief:
Protocol Section:
NCT04645420