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Investigating the role of JAK inhibition in achieving and maintaining disease remission in psoriatic arthritis (PsA).

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511401-40-00
Acronym
BN001/S63343
Enrollment
20
Registered
2024-04-03
Start date
2020-03-03
Completion date
2025-12-09
Last updated
2024-04-03

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

Conditions

Psoriatic Arthritis

Brief summary

- The proportion of patients achieving a status of clinical remission at week 24.

Detailed description

- The proportion of patients in drug-free remission at week 52 and week 104., - Time to relapse in patients experiencing a flare after treatment cessation., - The evolution of arthritis, dactylitis, enthesitis and skin involvement at week 4, week 12, week 24, week 28, week 52, week 76 and week 104, measured by : SJC66/TJC68; Dactylitis severity score; Leeds enthesitis index; BSA, - The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: PGA; Health Assessment Questionnaire – disability index (HAQ); Short Form-36 physical functioning domain(SF-36); EuroQol 5- dimension Health state Profile (EQ-5D); PsA Impact of Disease (PsAID), - Percentage of patients achieving the PsA response criteria (PsARC), minimal disease activity (MDA) and 85% change in Disease activity (DAPSA) at week 12, week 24, week 52, week 76 and week 104, - Radiographic progression at week 52 and week 104

Interventions

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
- The proportion of patients achieving a status of clinical remission at week 24.

Secondary

MeasureTime frame
- The proportion of patients in drug-free remission at week 52 and week 104., - Time to relapse in patients experiencing a flare after treatment cessation., - The evolution of arthritis, dactylitis, enthesitis and skin involvement at week 4, week 12, week 24, week 28, week 52, week 76 and week 104, measured by : SJC66/TJC68; Dactylitis severity score; Leeds enthesitis index; BSA, - The evolution of patient-reported outcomes at week 4, week 12, week 24, week 28, week 52, week 76 and week 104: PGA; Health Assessment Questionnaire – disability index (HAQ); Short Form-36 physical functioning domain(SF-36); EuroQol 5- dimension Health state Profile (EQ-5D); PsA Impact of Disease (PsAID), - Percentage of patients achieving the PsA response criteria (PsARC), minimal disease activity (MDA) and 85% change in Disease activity (DAPSA) at week 12, week 24, week 52, week 76 and week 104, - Radiographic progression at week 52 and week 104

Countries

Belgium

Outcome results

None listed

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