Arthritis interception with Guselkumab in subclinical psoriatic arthritis patients in clinical transition from skin to joint disease: a randomized clinical trial.

Condition studied

PSORIATIC ARTHRITIS PATIENTS IN CLINICAL TRANSITION

Investigational medicinal product(s)

Eligibility

Primary endpoint

The percentage of patients with subclinical PsA who achieve resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) together with the effect of guselkumab on objectively quantified synovio-entheseal inflammation, as co-primary objective endpoint evaluated using the UPsA activity activity Score [Timepoint: Week 24].

Endpoint detail

- The change of the synovio-entheseal inflammation score detected by US at w24 and w52, - The incidence of progression to PsA (defined as CASPAR criteria fulfilment) at w52, - The percentage of patients who achieved clinical resolution of arthralgia (defined as VAS pain ≤ 1/10 and TJC ≤ 1/10) at w52, - The percentage of patients who achieve PASI 100 at w24 and w52, - The change of the Patient Reported Outcomes (e.g. HAQ, BASDAI, DLQI, PsAID)., - Change in total modified Sharp–van der Heijde (mSvH) score from baseline to Week 52, including erosion score and joint space narrowing components.