ISRCTN10065623已完成2 期
Randomised controlled trial of the clinical effectiveness, SafetY and Cost effectiveness of Adalimumab in combination with MethOtRExate for the treatment of juvenile idiopathic arthritis associated uveitis
niversity Hospitals Bristol NHS Foundation Trust (UK)0 个研究点目标入组 90 人开始时间: 2011年9月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
研究概览
简要总结
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24405833 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28445659 2018 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/30336181 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31033434 (added 30/04/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion criteria as of 20/12/2016:
- •1. Children and young people aged = 2 and <18 years fulfilling ILAR diagnostic criteria for JIA (all subgroups that have uveitis)
- •2. At the time of trial screening the participant must have active anterior uveitis, defined as a sustained grade of cellular infiltrate in anterior chamber of SUN criteria grade >1+ or more 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). The participant must have been on MTX 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, in the 4 weeks prior to screening
- •5. Written informed consent of participant or parent/legal guardian, and assent where appropriate
- •6. Participant and parent/legal guardian willing and able to comply with protocol requirements
- •7. 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.
- •8. Able to be randomised and commence trial treatment within 2 weeks of the screening visit
- •* Omission of a maximum of 2 weeks methotrexate treatment within the 12 weeks is acceptable and will not render the patient ineligible unless they have been missed in the 4 weeks prior to the screening visit.
- •Original inclusion criteria:
- •1. A participant is eligible for the trials based upon at least one eye fulfilling the eligibility criteria
- •2. Children and young people aged between 2 and 18 years fulfilling International League of Associations for Rheumatology (ILAR) diagnostic criteria for JIA (all subgroups that have uvietis)
- •3. At the tie of trial screening the participant must have active anterior uveitis, defined as a sustained grade of cellular infiltrate in anterior chamber of Standardization of Uveitis Nomenclature (SUN) criteria grade =1+ or more during the preceding 12 weeks therapy despite MTX and corticosteroid (both systemic and topical) therapy
- •4. They must have failed MTX (minimum dose of 10-15mg/m2, with a maximum dose of 25mgs). The participant must have been on MTX for at least 12 weeks* and have been a stable dose for 4 weeks prior to screening visit.
- •5. Disease modifying immunosuppressive drugs, other than MTX, discontinued at least 4 weeks before receiving the first dose of adalimumab.
- •6. Written informed consent of participant or parent/legal guardian, and assent where appropriate
- •7. Participant or parent/legal guardian willing and able to comply with protocol requirements.
- •8. 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.
- •9. Able to be randomised and commence trial treatment within 2 weeks of the s
排除标准
- •Exclusion criteria as of 20/12/2016:
- •1. Uveitis without a diagnosis of JIA
- •2. Currently on adalimumab or has previously received adalimumab.
- •3. Have been on other biologic agent within previous 5 half-lives of agent (For other biologic agents and their was out periods
- •4. 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 screening visit)
- •5. For patients on Prednisone or Prednisone equivalent, change of dose within 30 days prior to screening
- •6. For patients on Prednisone or Prednisone equivalent with a dose >0.2mg/kg per day
- •7. Intra-articular joint injections within four weeks prior to screening
- •8. Any ongoing chronic or active infection (including infective uveitis) or any major episode of infection requiring hospitalisation or treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to the screening evaluation
- •9. History of active tuberculosis of less than 6 months treatment or untreated latent TB
- •10. Participant has history of central nervous system (CNS) neoplasm, active CNS infection, demyelinating disease, or any progressive or degenerative neurological disease
- •11. Poorly controlled diabetes or persistently poorly controlled severe hypertension (>95th percentile for height / age) as deemed by the treating physician
- •12. Previous history of malignancy
- •13. Intraocular surgery within the 3 months prior to screening (cataract/ glaucoma/ vitrectomy)
- •14. Intra-ocular or peri-ocular corticosteroids within 30 days prior to screening.
- •15. History of ocular herpetic disease
- •16. Pregnant or nursing female
- •17. Demonstrations of clinically significant deviations in any of the following laboratory parameters:
- •17.1. Platelet count < 100,000/mm3
- •17.2. Total white cell count < 4000 cells/mm3
- •17.3. Neutrophils < 1000 cells/mm3
- •17.4. AST or ALT > 2 x upper limit of normal (ULN) or serum bilirubin > 2x the ULN
- •17.5. Glomerular filtration rate (GFR) of < 90 mL/min/1.73m2 [GFR (ml.min/1.73 m2 BSA) = 0.55 x height (cm)/plasma creatinine (mg/dl)]
- •17.6. Hematocrit <24%
- •18. Having been administered a live or attenuated vaccine within three months prior to screening
- •19. Previous randomisation into the SYCAMORE trial to either arm of the trial.
- •20. Intra-ocular pressure <6mm Hg or Intra-ocular pressure > 25mm Hg
- •21. Intra-ocular pressure control requiring more than one topical pressure lowering therapy or requiring systemic acetazolamide
- •Original exclusion criteria:
- •1. Uveitis without a diagnosis of JIA
- •2. Currently on adalimumab or has previously failed on adalimumab
- •3. Have been on other biologic agent within previous 5 half-lives of agent (For other biologic agents and their washout periods
- •4. More than 6 topical steroid eye drops per day at randomisation (this dose must have been stable for at least 4 weeks prior to screening visit)
- •5. For patients on Prednisone equivalent, chan
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