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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT04106804
Eligibility Criteria:
Inclusion Criteria:
* Males/females with CASPAR criteria-positive PsA
* Active disease with more than three swollen and tender joints
* Must be aged ≥ 18 years at time of consent
* ≥ 3 erosions on MRI or HR PQCT
* Women of childbearing potential or men capable of fathering children must be using effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
* Must understand and voluntarily sign an informed consent form including written consent for data protection ´- Must be able to adhere to the study visit schedule and other protocol requirements
Exclusion Criteria:
* Previous exposure to abatacept
* CCP2 positivity
* Investigational study drug within 4 weeks (or 5 halflives (half live is 14,3 days), whichever is longer) prior to randomisation
* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
* Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
* Any malignancy in the last 5 years
* Chronic infection such as latent TB (TB not adequately treated according to guidelines) or hepatitis B or C infection
* Immunocompromised or HIV-positive patients
* Uncontrolled severe concomitant disease
* Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG).
* Pregnant or lactating females
* Patients who possibly are dependent on the Principal Investigator or
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04106804
Study Brief:
Protocol Section:
NCT04106804