Phase
Condition
Joint Injuries
Psoriatic Arthritis
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 usingeffective contraception during treatment with abatacept and up to 14 weeks after thelast dose of abatacept treatment.
Must understand and voluntarily sign an informed consent form including writtenconsent for data protection ´- Must be able to adhere to the study visit schedule andother protocol requirements
Exclusion
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 thesubject at unacceptable risk if he/she were to participate in the study or confoundsthe ability to interpret data from the study
Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcetdisease, vasculitis or autoimmune hepatitis.
Any malignancy in the last 5 years
Chronic infection such as latent TB (TB not adequately treated according toguidelines) 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 (accordingto § 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
Study Design
Study Description
Connect with a study center
University Clinic Erlangen, Medical Department 3, Rheumatology & Immunology
Erlangen, 91054
GermanyActive - Recruiting
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