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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT03780504
Eligibility Criteria:
Inclusion Criteria:
Patients eligible for inclusion in this study have to meet all of the following criteria:
* Male or female outpatients ≥18 years of age at the time of apremilast treatment onset;
* Patients diagnosed with active peripheral PsA (as per physician's clinical judgement) who have had an inadequate response (to at least one DMARD and within the first 12 months of treatment) or who have been intolerant to a prior DMARD therapy;
* Patients who have been prescribed treatment with apremilast (Otezla®) for PsA, either as a monotherapy or combination therapy with classical systemic DMARD, prior to signed Informed Consent and for whom, if treatment has started, no more than one week has elapsed from treatment initiation to obtaining the signed Informed Consent;
* Patients for whom the decision to prescribe therapy with apremilast according to the locally approved SmPC has already been taken prior to their enrollment in the study and is clearly separated from the physician's decision to include the patient in the current study;
* Patients with available information on the measures needed for the calculation of cDAPSA score at the start of apremilast treatment (i.e., number of swollen and tender joints based on the 66 swollen joint count and the 68 tender joint count, respectively, and patient global assessments of disease activity and pain);
* Patients must be able to read, understand and complete the study specific questionnaires;
* Patients must provide a written Informed Consent prior to inclusion to the study;
* Patients must be able to understand the study procedures and adhere to the study visit schedule.
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from participation in this study:
* Patients who have a history of exposure to biologic treatment and/or to tofacitinib in PsA;
* Patients that meet any of the contraindications to the administration of the apremilast as outlined in the latest version of the locally approved SmPC;
* Patients who currently receive treatment with any investigational drug/device/intervention or who have received any investigational product within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the start of therapy with apremilast;
* Patients who are currently pregnant, breastfeeding, or planning a pregnancy during the study observation period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03780504
Study Brief:
Protocol Section:
NCT03780504