Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients Receiving JAK-inhibitor vs. TNF-inhibitor Therapy for Active Rheumatoid Arthritis: A Feasibility Study.
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 主要终点
- Retention Rate
研究概览
简要总结
The purpose of this phase 4 pilot study is to assess 1-year recruitment, and 6-month retention rates for participants with rheumatoid arthritis (RA) recruited to this study. Secondarily, we aim to study the difference in multifaceted pain scoring and Musculoskeletal Ultrasound (MSK-US)-detected synovitis between those treated with Upadacitinib vs Adalimumab.
详细描述
This is a 26-week phase 4 randomized, single-blind, parallel-group, active treatment-controlled pilot/feasibility study designed to primary assess recruitment and retention rates and to secondarily assess the efficacy of Upadacitinib vs Adalimumab in controlling multiple measures of pain and MSK-US-detected synovitis in those with Active Rheumatoid Arthritis.
Participants with active RA despite combination conventional synthetic Disease Modifying Antirheumatic Drugs (csDMARD), alternative biologic DMARD (bDMARD), or alternative targeted synthetic DMARD (tsDMARD) will be randomized in a 1:1 ratio to:
- Upadacitinib(Rinvoq) 15 mg orally (po) daily or
- Comparison Group: Adalimumab(Idacio) 40 mg subcutaneously (sc) every other week Baseline methotrexate may be continued if patient is receiving at time of study enrollment.
At 1 year after study initiation, recruitment rate over the first year will be measured and rate of 6-month participant retention will also be measured.
At baseline, 1 month, 3 months, and 6 months after initiation of study drug, disease activity, pain, MSK-US synovitis, and other patient important outcomes will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
MSK-US assessors will be blinded to treatment allocation, pain scores, and disease activity measures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA based on ACR/EULAR 2020 Classification Criteria
- •Moderate-to-high disease activity according to clinical disease activity indices
- •Referred to the biologics clinic (The Ottawa Hospital Arthritis Centre) by their primary rheumatologist who practices within the division following decision to escalate to, or switch between, advanced therapy.
排除标准
- •Any contraindication to initiation of either Upadacitinib or Adalimumab
- •Unable to come to follow-up at 1, 3, and 6 months
- •Current or planned (within 6 months) pregnancy or breastfeeding
- •Inability to give informed consent
- •Inability to communicate verbal or written responses to pain questionnaires
- •Intraarticular steroid injections if done within 30 days of first visit
- •Initiation of study intervention prior to baseline assessment
- •Previous use of either study drug
研究组 & 干预措施
Upadacitinib(Rinvoq)
Upadacitinib(Rinvoq) 15 mg po daily
干预措施: Upadacitinib (Drug)
Adalimumab(Idacio)
干预措施: Adalimumab (Drug)
结局指标
主要结局
Retention Rate
时间窗: 6 months
Proportion of participants who complete the 6 months of follow-up
Recruitment Rate
时间窗: 1 year
Number of participants recruited to study
次要结局
- Change in 100 mm Pain visual analogue scale (VAS)(6 months)
- Change in McGill Pain Questionnaire (MPQ)(6 months)
- Change in Widespread Pain Index (WPI)(6 months)
- Change in OMERACT (Outcome Measures in Rheumatoid Arthritis in Clinical Trials) ultrasound task force Global Synovitis Score (GLOESS).(6 months)
- Change in Swollen Joint Count (44)(6 months)
- Change in Tender Joint Count (44)(6 months)
- Change in PainDETECT Questionnaire (PDQ)(6 months)
- Change in DAS-28-CRP(6 Months)
- Change in Clinical Disease Activity Index (CDAI)(6 months)
- Change in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT)(6 months)
- Change in Insomnia Severity Index (ISI)(6 months)
- Change in Physician Global Assessment of Disease Severity(6 months)
- Change in Patient Global Assessment of Disease Severity(6 months)
- Change in Health Assessment Questionnaire(6 months)
- American College of Rheumatology (ACR) 20 response(6 months)
- ACR 50 response(6 months)
- ACR 70 response(6 months)
- Change in Erythrocyte Sedimentation Rate(6 months)
- Change in C-Reactive Protein(6 months)
- Change in Disease Activity Score (DAS)-28-ESR(6 months)
- Change in Short Form 36 (SF-36)(6 months)
- Change in Patient Health Questionnaire (PHQ-9)(6 months)
- Adverse Events(6 months)
- Serious Adverse Events(6 months)
- Drop-out due to Adverse Events(6 months)