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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523551-54-00

Acronym

ARREST

Enrollment

Registered

2026-01-14

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PSORIATIC ARTHRITIS PATIENTS IN CLINICAL TRANSITION

Brief summary

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].

Detailed description

- 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.

Interventions

DRUGCICLOSPORIN

DRUGGuselkumab - solution for injection in pre-filled syringe - 100 mg/mL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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].	—

Secondary

Measure	Time frame
- 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.	—

Measure

Time frame

—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026