2025-522118-21-00招募中4 期
Impact Of Upadacitinib On The Frequency Of Acute Recurrent Anterior Uveitis In Patients With Axial Spondyloarthritis (UP-FOR-U)
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 13
- 主要终点
- Change in exposure-adjusted opthalmologist (or optometrist or rheumatologist)-diagnosed AAU event rate per 100 patient years (EAER) over 52 weeks on upadacitinib compared to the AAU EAER in the 104 week pre-study period, separately in bDMARD-naive and bDMARD experienced groups.
研究概览
简要总结
To evaluate the impact of upadacitinib on the frequency of recurrent acute anterior uveitis (AAU) over 52 weeks in subjects with active axial spondyloarthritis (axSpA) and a prior AAU event in the 104 weeks prior to baseline, who are switching from bDMARDs (in North America and Europe), or who are bDMARD-naïve (in Europe), in real-world practice.
研究设计
- 分配方式
- Na
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥18 years of age at the screening visit.
- •Classification of axSpA according to the 2009 ASAS Classification Criteria.
- •History of at least one acute anterior uveitis (AAU) event in the 104 weeks prior to baseline, diagnosed by an ophthalmologist (or optometrist/rheumatologist as necessary)
- •Historical documentation of AAU by an ophthalmologist at any time in the past.
- •Active axSpA disease, defined by: BASDAI ≥ 4, and Total Back Pain (TBP) ≥ 4 on a 0–10 numerical rating scale at both screening and baseline.
- •Inadequate response to ≥2 different NSAIDs over at least 4 weeks total at maximum tolerated doses, or documented intolerance/contraindication to NSAIDs.
- •Mixed population of: bDMARD-naïve subjects, and bDMARD-inadequate responders (bDMARD-IR) or bDMARD-intolerant subjects.
- •Any condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- •Treatment history requirements by region: Europe: may be bDMARD-naïve (up to 100 subjects) or bDMARD-IR/intolerant. USA: must have received TNFi and be a TNFi-inadequate responder or intolerant. Canada: must have previously received a bDMARD and be bDMARD-IR or intolerant.
- •For nr-axSpA subjects: must have objective signs of inflammation (elevated CRP and/or positive MRI) based on standard-of-care.
- •Contraception/pregnancy-related requirements for females of childbearing potential: Negative serum pregnancy test at screening and negative urine pregnancy test at baseline. Must use protocol-specified birth control methods from Day 1 through at least 30 days after the last dose. Must not be pregnant, breastfeeding, or planning pregnancy during study and for 30 days after last dose.
- •Stable doses required before baseline for the following medications: NSAIDs or analgesics (including low-potency opioids) for ≥7 days. Oral corticosteroids (≤10 mg prednisone equivalent/day) for ≥14 days.
- •Subjects on csDMARDs must discontinue and wash out for ≥28 days prior to baseline.
- •If on bDMARD at screening, must undergo appropriate washout per local SOC.
- •Able to understand, willing to adhere to protocol requirements, and provides written informed consent before any study procedures.
- •Diagnosis of axial spondyloarthritis (axSpA) by a treating rheumatologist.
排除标准
- •Subject with chronic inflammatory articular disease (other than axSpA or systemic autoimmune diseases)
- •History of major adverse cardiovascular event (MACE), including but not limited to myocardial infarction and cerebrovascular accident
- •Clinically significant laboratory abnormalities at screening (e.g., hemoglobin < 9 g/dL, ALT or AST > 2 × ULN, eGFR < 30)
- •Positive pregnancy test at screening or baseline.
- •Any gastrointestinal condition or surgical history that could interfere with the absorption of oral medication.
- •Subject who is breastfeeding or planning pregnancy during the study or within 30 days after the last dose.
- •History of hypersensitivity to upadacitinib or any of its components
- •Primary or secondary immunodeficiency
- •Previous exposure to upadacitinib or other Janus kinase (JAK) inhibitors
- •Use of any investigational drug or device within 30 days or five half-lives (whichever is longer) prior to baseline.
- •Use of systemic immunosuppressants (e.g., methotrexate, azathioprine, cyclosporine) within 28 days prior to baseline.
- •Evidence of active, serious, or chronic infection, including localized infections.
- •Known history of, or active, tuberculosis (TB), or latent TB without completion of adequate anti-TB therapy prior to baseline.
- •Chronic infection of human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or other clinically significant viral infection.
- •Current or recent (within 5 years) malignancy, except for adequately treated non-melanoma skin cancer or in situ cervical cancer.
研究组 & 干预措施
RINVOQ 15 mg prolonged-release tablets
Test
干预措施: RINVOQ 15 mg prolonged-release tablets (Drug)
结局指标
主要结局
Change in exposure-adjusted opthalmologist (or optometrist or rheumatologist)-diagnosed AAU event rate per 100 patient years (EAER) over 52 weeks on upadacitinib compared to the AAU EAER in the 104 week pre-study period, separately in bDMARD-naive and bDMARD experienced groups.
Change in exposure-adjusted opthalmologist (or optometrist or rheumatologist)-diagnosed AAU event rate per 100 patient years (EAER) over 52 weeks on upadacitinib compared to the AAU EAER in the 104 week pre-study period, separately in bDMARD-naive and bDMARD experienced groups.
次要结局
- Percentage of Participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at week 24 in (i) bDMARD-IR (ii) bDMARD-naive groups
- Percentage of participants Achieving Ankylosing Spondylitis Disease Activity Score Low Disease Activity (ASDAS LDA [< 2.1]) at weeks 24 and 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups
- Percentage of Participants Achieving Assessment of Spondyloarthritis International Society Health Index (ASAS-HI) Score of less than or equal to 5, up to week 52 in (i) bDMARD-IR; (ii) bDMARD-naive groups
- Incidence of Adverse Events (AEs) and Adverse Events of Special Interest (AESIs), AEs and AESIs leading to withdrawal from study drug, and serious AEs (SAEs).
研究者
Dr. Walter Maskymowych
Scientific
Care Arthritis Ltd.
研究点 (13)
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