Abatacept Bone Effects in Psoriatic Arthritis With Bone Biomarker

• Status: Recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Observation has pointed out, that osteitis present in the MRI scans, predicts bone erosion and that this in accordance with the concept by underlining the importance of bone marrow involvement in arthritis [Krabben A, 2013]. Abatacept with its favourable safety profile preferentially interrupts activation of naïve T cells and perhaps makes the strongest case for exploiting co-stimulatory blockade during the earliest detectable phase of the adaptive immune response at a time when predisposition to autoimmune disease can be detected.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School
• Treatments: Abatacept

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