ISRCTN12427150进行中（未招募）2 期
A randomised controlled trial of secukinumab versus adalimumab for the treatment of juvenile idiopathic arthritis (JIA) associated uveitis or chronic anterior uveitis using a Bayesian design
niversity Hospitals Bristol and Weston NHS Foundation Trust0 个研究点目标入组 50 人开始时间: 2023年2月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Children and young people aged = 2 and <18 years fulfilling ILAR diagnostic criteria for JIA (all subgroups that have uveitis) with associated uveitis, or chronic anterior uveitis with no known associated autoimmune disease
- •2. SUN grade =1+ or more for two clinic visits during the preceding 12 weeks’ therapy despite MTX or MMF, adalimumab and corticosteroid therapy (both systemic and topical). The latest date of SUN grade score must be the date of the screening visit.
- •3. They must have failed adalimumab ((< 30kg 20mg every 2 weeks, > 30 kgs 40mg every 2 weeks).) during the 12 weeks prior to screening. The participant must have been on MTX or MMF for at least 12 weeks* and have been on a stable dose for 4 weeks prior to screening visit.
- •4. No Disease modifying immunosuppressive drugs, other than MTX or MMF, in the 4 weeks prior to screening
- •5. Participant and parent/legal guardian willing and able to comply with protocol requirements and provide written informed consent, and assent where appropriate.
- •6. For participants of reproductive potential (males and females), use of a reliable means of contraception throughout their trial participation. Post pubertal females must have a negative serum pregnancy test within 10 days before the first dose of trial drug.
- •7. Able to be registered and commence trial treatment within 2 weeks of the screening visit.
- •1. Children and young people aged = 2 and <18 years fulfilling ILAR diagnostic criteria for JIA (all subgroups that have uveitis) with associated uveitis, or chronic anterior uveitis with no known systemic autoimmune disease .
- •2. SUN grade =1+ or more for two clinic visits during the preceding 12 weeks’ therapy despite MTX and corticosteroid (both systemic and topical) therapy”. The latest date of SUN grade score must be the date of the screening visit.
- •3. They must have failed MTX (minimum dose of 10-20mg/m2, with a maximum dose of 25mg/participant) or MMF (minimum dose of 300/m2 twice a day to maximum dose 600/m2 twice a day). The participant must have been on MTX or MMF for at least 12 weeks* and have been on a stable dose for 4 weeks prior to screening visit.
- •4. No Disease modifying immunosuppressive drugs, other than MTX or MMF, in the 4 weeks prior to screening
- •5. Participant and parent/legal guardian willing and able to comply with protocol requirements and provide written informed consent, and assent where appropriate.
- •6. For participants of reproductive potential (males and females), use of a reliable means of contraception throughout their trial participation. Post pubertal females must have a negative serum pregnancy test within 10 days before the first dose of trial drug.
- •7. Able to be randomised and commence trial treatment within 2 weeks of the screening visit.
- •* Omission of a maximum of 2 weeks MTX or MMF treatment within the 12 weeks is acceptable and will not render the patient ineligible unless they have missed 2 weeks of treatment in the 4 weeks prior to the screening visit.
排除标准
- •Eligibility Criteria for Biologic Refractory Participants (stage 1)
- •1. Uveitis associated with infection, or history of ocular herpetic disease
- •2. Active inflammatory disease other than JIA and Uveitis
- •3. Currently on a biologic agent or has previously received any other biologic agent (other than adalimumab.)
- •4. Have been on adalimumab within previous 4 weeks
- •5. Currently on more than 1 disease-modifying anti-rheumatic drug (DMARD)
- •6. Chronic uncontrolled JIA and/or uveitis for more than 52 weeks
- •7. More than 6 topical steroid eye drops per eye, per day prior to screening (this dose must have been stable for at least 4 weeks prior to registration)
- •8. For patients on Prednisone or Prednisone equivalent, dose >0.2mg/kg per day or change of dose within 4 weeks prior to registration
- •9. Intra-articular joint injections within 4 weeks prior to registration
- •10. History or current diagnosis of Electrocardiogram (ECG) abnormalities indicating significant risk of safety for patients participating in the study such as:
- •10.1. Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- •10.2. History of familial long QT syndrome or known family history of Torsades de Pointes.
- •11. Underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal conditions which in the opinion of the Investigator immunocompromises the subject and/or places the subject at unacceptable risk for participation in a study with an immunomodulatory treatment.
- •12. History of active tuberculosis of less than 24 weeks treatment or untreated latent TB or evidence of Latent TB (positive QuantiFERON or PPD at screening) but unwilling or unable to complete a minimum of 4 weeks of latent TB treatment before initiating treatment with secukinumab
- •13. Participant has history of central nervous system (CNS) neoplasm, active CNS infection, demyelinating disease, or any progressive or degenerative neurological disease
- •14. Poorly controlled diabetes or persistently poorly controlled severe hypertension (>95th percentile for height / age) as deemed by the treating physician
- •15. Previous history of malignancy
- •16. Intraocular surgery within the 12 weeks prior to screening (cataract/ glaucoma/ vitrectomy)
- •17. Peri-ocular corticosteroids within 4 weeks prior to screening or intraocular steroid at any time.
- •18. Pregnant or nursing female
- •19. Demonstrations of clinically significant deviations in any of the following laboratory parameters:
- •19.1. Screening total white blood cell (WBC) count < 3,000/µL, or platelets < 100,000/µL or neutrophils < 1,500/µL or haemoglobin < 8.5 g/dL (85 g/L). Any single parameter may not exceed 2 x upper limit of normal (ULN). A single parameter elevated up to and including 2 x ULN should be re-checked once more as soon as possible, and in all cases, at least prior to baseline, to rule out lab error.
- •19.2. Serum bilirubin exceeding the value of 1.6 mg/dL (27 µmol/L).
- •20. Having been administered a liv
研究者
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