2022-502578-18-00招募中4 期
A Phase 3b/4 Randomized, Double-Blind, Double-Dummy, Active-Comparator Controlled Study, Comparing the Efficacy and Safety of Upadacitinib Versus Adalimumab in Subjects with Moderate to Severe Rheumatoid Arthritis on a stable background of MTX and who had an Inadequate Response or Intolerance to a Single TNF Inhibitor (SELECT- SWITCH)
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 49
- 主要终点
- The primary endpoint is achievement of DAS28-CRP ≤ 3.2 at Week 12. DAS28-CRP will be calculated based on the values of TJC28, SJC28, PtGA, and hsCRP.
研究概览
简要总结
To evaluate the efficacy and safety of upadacitinib and adalimumab, in adult subjects with rheumatoid arthritis on background MTX, following an inadequate response or intolerance to a single TNFi.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult individuals, ≥ 18 years old at screening.
- •Diagnosis of RA for ≥ 3 months prior to screening based on the 2010 ACR/EULAR classification criteria for RA.
- •Subject have been treated for ≥ 3 consecutive months prior to screening with 1 TNFi (only 1 of originator or biosimilar certolizumab pegol, etanercept, golimumab or infliximab) for RA, but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity, irrespective of treatment duration. Up to 15% of subjects who were intolerant to 1 TNFi will be allowed to enroll. • Prior administration of different biosimilar versions for the same originator TNFi or switching between originator and biosimilar version of the same originator TNFi are acceptable. Cycling between biosimilars of different originator TNF inhibitors is not acceptable.
- •Subject meets both of the following disease activity criteria: a) ≥ 6 swollen joint (based on 66 joint counts) and ≥ 6 tender joints (based on 68 joint counts) at screening and baseline; b) hsCRP ≥ 3 mg/L (central lab, ULN 2.87 mg/L) at screening.
- •Subjects must have been on oral or parenteral MTX therapy ≥ 3 consecutive months and on a stable prescription of 15 to 25 mg/week (or ≥ 10 mg/week in subjects intolerant of MTX at doses ≥ 15 mg/week) for ≥ 4 weeks prior to the first dose of study drug. In addition, all subjects should take a dietary supplement of folic acid or folinic acid throughout the study participation.
排除标准
- •Subject with prior exposure to any JAK inhibitor (including but not limited to upadacitinib, tofacitinib, baricitinib, filgotinib, and deucravacitinib).
- •Subject treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug or is currently enrolled in another interventional clinical study.
- •Subject must not have any of the following medical diseases or disorders: - Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, and aortocoronary bypass surgery. - History of moderate to severe congestive heart failure (NYHA Class III or IV). - Clinically relevant or significant ECG abnormalities, including ECG with QT interval corrected for heart rate using Fridericia's formula (QT interval corrected for heart rate using Fridericia's formula) > 450 msec (males) or > 470 msec (females). - History of malignancy except for successfully treated NMSC or localized carcinoma in situ of the cervix. - History of GI perforation (other than appendicitis or penetrating injury), diverticulitis or significantly increased risk for GI perforation per investigator judgment. - Conditions that could interfere with drug absorption including but not limited to short bowel syndrome or gastric bypass surgery; subjects with a history of gastric banding/segmentation are not excluded. - History of demyelinating disease such as multiple sclerosis. - History of an organ transplant which requires continued immunosuppression.
- •Current or past history of infection including: - Two or more episodes of herpes zoster, or 1 or more episodes of disseminated herpes zoster; - One or more episodes of disseminated herpes simplex (including eczema herpeticum); - HIV infection defined as confirmed positive HIV Ab and Ag test; - Active TB or meet TB exclusionary parameters; - Active infection(s) requiring treatment with intravenous anti-infectives within 30 days, or oral/intramuscular anti-infectives within 14 days prior to baseline; - Chronic recurring infection and/or active viral infection that, based on the investigator's clinical assessment, makes the subject an unsuitable candidate for the study; - COVID-19 infection: For any asymptomatic subject who tested positive for COVID, at least 5 days must have passed since a COVID-19 positive test result for study entry. - Subjects must not have evidence of active HBV or HCV infection.
- •Subject with any exposure to: - adalimumab (original or biosimilar) or to any approved or investigational TNF inhibitor other than infliximab, etanercept, certolizumab pegol and golimumab. - an approved or investigational non-TNFi bDMARD or tsDMARD
研究组 & 干预措施
-
Auxiliary
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
The primary endpoint is achievement of DAS28-CRP ≤ 3.2 at Week 12. DAS28-CRP will be calculated based on the values of TJC28, SJC28, PtGA, and hsCRP.
The primary endpoint is achievement of DAS28-CRP ≤ 3.2 at Week 12. DAS28-CRP will be calculated based on the values of TJC28, SJC28, PtGA, and hsCRP.
次要结局
- Achievement of ACR50 at Week 12. Achievement of ACR50 response will be determined based on 50% or greater improvement in TJC68 and SJC66 and ≥ 3 of the 5 measures of Patient's Assessment of Pain (past week, NRS), Patient's Global Assessment of Disease Activity (PtGA [past week, NRS]), Physician's Global Assessment of Disease Activity (PhGA [NRS]), HAQ-DI, or hsCRP.
- Achievement of DAS28-CRP < 2.6 at Week 12
- Change from baseline in DAS28-CRP at Week 12
- Change from baseline in Patient's Assessment of Pain at Week 12
- Change from baseline in HAQ-DI at Week 12
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
研究点 (49)
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