Exploratory research on therapeutic optimization parameters for upadacitinib by single-cell analysis of synovial tissue and peripheral blood from rheumatoid arthritis and psoriatic arthritis patients

Phase 2

Recruiting

• Conditions: Rheumatoid arthritis or Psoriatic arthritis; RA,PsA

• Registration Number: JPRN-jRCTs031230485
• Lead Sponsor: Fujio Keishi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-30
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

(1). Patients with RA or PsA (for RA, patients must fulfill the 2010 ACR/EULAR classification criteria, and for PsA, patients must fulfill the CASPAR classification criteria).
(2). Patients with disease activity (TJC>=3 and SJC>=3).
(3). Patients aged 18 years and above.
(4). Patients who have had inadequate efficacy or difficulty continuing with one or more csDMARDs and one or fewer bDMARDs due to insufficient effectiveness or adverse events.
(5). Gender: Not restricted.
(6). Patients who have received sufficient explanation regarding participation in this study, have understood it adequately, and have provided written consent based on their own free will.
(7). Patients who can attend outpatient visits in accordance with the study implementation schedule.
(8). Patients for whom residual samples of synovial tissue have been collected and stored for purposes other than this study within the 4 weeks prior to obtaining consent.

Exclusion Criteria

(1). Patients with a history of hypersensitivity to components of upadacitinib (UPA).
(2). Patients with active severe infections.
(3). Patients with active tuberculosis.
(4). Patients with severe liver dysfunction (Child-Pugh Score C).
(5). Patients who are carriers or have a history of hepatitis B virus (negative for HBsAg and positive for either HBcAb or HBsAb). However, if HBV DNA is negative, participation is possible with attention to signs and symptoms of hepatitis B virus reactivation while monitoring liver function test values and HBV DNA.
(6). Patients who are carriers of hepatitis C virus.
(7). Patients with neutrophil count < 1000 / mm3, lymphocyte count < 500 / mm3, or Hb < 8 g/dL.
(8). Patients who are pregnant or possibly pregnant.
(9). Other individuals deemed inappropriate for participation in this study by the principal investigator or participating physicians.

Study & Design

• Study Type: Interventional
• Study Design: Not specified