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 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT04517669
Eligibility Criteria:
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Patients aged ≥ 18 years
2. Moderate to severe PsA disease activity diagnosed
3. Patients for whom the physician's decision has been made to initiate treatment with tofacitinib, in usual clinical practice conditions and in compliance with the local label
4. Patients are treatment naïve to tofacitinib on the date of providing informed consent
5. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study
6. Patients on DMARDs must have not had a treatment change in the past 3 months
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:
1. Contraindications according to the Xeljanz® (tofacitinib) Prescribing Information
2. Receipt of any investigational drug within 3 months before study inclusion
3. Patient is pregnant or breastfeeding
4. Recent herpes zoster infection (within past 6 months) or history of severe disseminated herpes zoster infection
5. Active treatment for a malignancy
6. Concomitant treatment with a biological disease-modifying antirheumatic drugs (bDMARD)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04517669
Study Brief:
Protocol Section:
NCT04517669