A multi-centre, open-label, parallel-group randomised controlled trial of disease-modifying anti-rheumatic drug (DMARD) dose maintenance (USUAL CARE) vs DMARD discontinuation after reduction (STOP) in adult patients with rheumatoid arthritis and psoriatic arthritis on stable biologic or targeted synthetic (b/ts) DMARD therapy +/- conventional synthetic (cs)DMARD/s, who are in sustained low disease activity at baseline

niversity of Sydney0 个研究点目标入组 324 人开始时间: 2021年12月10日最近更新: 2023年12月12日

适应症

试验速览

暂无简介。

•Age >=18 years
•- RA diagnosed according to the ACR/EULAR 2010 diagnostic criteria or PsA diagnosed according to the CASPAR diagnostic criteria
•- Stable on biologic therapy (b/tsDMARDs*) ± concurrent csDMARDs** for >=6 months duration
•- First started any b/tsDMARDs >=2 years ago (not early disease)
•- RA only: DAS28CRP REM or LDA <3.2 at start (T-3) and end of 3-month run-in period (T0)
•- PsA only: VLDA (7 of 7 MDA criteria) or MDA (>=5 of 7 MDA criteria) at start (T-3) and end of 3-month run-in period (T0)
•- If on oral steroids the dose must be stable and <=5mg prednisone daily equivalent
•*RA: includes abatacept, adalimumab, baricitinib, certolizumab pegol, etanercept, golimumab, infliximab, tocilizumab, tofacitinib, upadacitinib
•*PsA: includes adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, ixekizumab, secukinumab, tofacitinib, upadacitinib
•**includes methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, azathioprine

•All exclusion
•- Patients with concurrent medical conditions that in the opinion of the treating rheumatologist are likely to impact the patient’s safety or interfere with the evaluation of the study outcome (e.g. short life expectancy or planned major surgery).
•- Patients who are unable/unwilling to provide informed consent for both the clinical trial, and A3BC Biobank-Registry participation for the full duration of the trial.
•- Patients with insufficient English language understanding and communication skills (and without access to an interpreter) sufficient to provide informed consent and/or understand and participate in study processes.
•- Patients who are on >5mg daily prednisone equivalent glucocorticoids or who have had any parenteral or intra-articular glucocorticoids in the last 6 months.
•- Patients who are primarily on immunomodulating agents for other health conditions, for example b/tsDMARDs for Crohn’s disease.
•- Patients who are taking any excluded DMARDs: rituximab, ustekinumab, guselkumab, penicillamine, ciclosporin, apremilast.
•- Female patients who are pregnant or breastfeeding or planning a pregnancy during the study period.
•- Patients who had an investigational new drug within the last 12 weeks.
•- Patients with a history of neurological/psychological illness or condition such as to interfere with the patient’s ability to understand the requirements of the study.

发起方