2022-502968-20-02招募中2 期
Drug Rediscovery for rare Immune Mediated Inflammatory Diseases (DRIMID)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- EuroQol 5D-5L (EQ-5D-5L) form
研究概览
简要总结
To determine the effects of filgotinib, an approved JAK-inhibitor, on changes in quality of life, disease activity and safety in patients with refractory BD, IIM and IgG4-RD
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Trial stage 2 - group 6
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of older
- •Refractory disease, defined as symptomatic disease that persists despite a 12-week trial of corticoid therapy as well as lack of response to at least prednisone and one other immunosuppressive agent such as methotrexate (MTX), mycophenolate mofetil (MMF), azathioprine (AZA) or rituximab or intolerance to standard-of-care treatment, as defined by the treating physician.
- •No evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (TB) as defined by all of the following: both a negative QuantiFERON-TB Gold (QFT-G) In-Tube test and a Mantoux tuberculin skin test performed at or within 3 months prior to screening and no signs suggestive of active TB infection as determined (and documented) by a qualified radiologist or pulmonologist as per local standard of care on a chest radiograph and no history of either untreated or inadequately treated latent or active TB infection.
- •One of the following: (1) Diagnosis of Behçet’s disease without refractory life, organ or sight-threatening symtoms with active disease, defined as a BDCAF >2 (new BDCAF) or >15 (old BDCAF) or with active disease, based on clinical grounds (e.g. the need to start new or additional medication) or (2) Diagnosis of idiopathic inflammatory myopathy, according to diagnostic criteria: Dermatomyositis Classification Criteria according to the European Neuromuscular Centre guidelines 2018 or Anti-synthetase syndrome Classification Criteria according to the European Neuromuscular Centre guidelines 2003 with active disease, defined as: dermatomyositis with a CDASI score of ≥5 or abnormal levels of at least 1 of the following enzymes: creatine kinase (≥ 4× upper limit of normal [ULN]), aldolase (≥4× ULN), lactate dehydrogenase (LDH ≥4× ULN), aspartate transaminase (AST ≥4× ULN), alanine aminotransferase (ALT ≥4× ULN) or MRI within the last 3 months indicative of active inflammation (e.g. edema signal pattern in affected proximal muscles) or active disease based on clinical grounds, e.g. the need to start new or additional medication or (3) Diagnosis of IgG4-related disease, according to 2019 ACR/EULAR guidelines with active disease, defined as: IgG4-related disease responder index >10 or active disease based on clinical grounds, e.g. the need to start new or additional medication
排除标准
- •Age <18 years
- •Known recent substance abuse (drugs or alcohol).
- •Poor tolerability of venipuncture or lack of adequate venous access for required blood sampling during the study period.
- •Life expectancy less than 6 months
- •Previous non-adherence to immunosuppressants
- •Hypersensitivity to the active substance or to any of the excipients
- •Rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •Juvenile DM, myositis overlapping with other autoimmune diseases, immune mediated necrotizing myopathy (IMNM) or cancer-associated myositis
- •End-stage IIM wherein muscle weakness is most likely due to muscle damage, rather than myositis disease activity
- •Pregnancy or lactation
- •Previous use of other JAK-inhibitors
- •History of VTE
- •Use of any investigational drug within one month prior to screening or within five half-lives of the investigational agent, whichever is longer.
- •History of HIV
- •Presence of an active infection or hepatitis
- •Age ≥65 years
- •Increased risk of major cardiovascular problems
- •Current smoker or smoked for a long time in the past
- •Increased risk of cancer
- •Concomitant malignancies or previous malignancies within the last five years (with exception of adequately treated basal or squamous cell carcinoma of the skin)
- •Kidney injury with estimated glomerular filtration rate <15mL/min/1.73m2
- •Liver failure Child Pugh C
- •Absolute neutrophil count <1*109
- •Absolute leukocyte count <0.5*109
- •Hemoglobin <5mmol/L
- •Inability to comply with study and/or follow-up procedures
结局指标
主要结局
EuroQol 5D-5L (EQ-5D-5L) form
EuroQol 5D-5L (EQ-5D-5L) form
Behçet’s Disease Current Activity Form (BDCAF)
Behçet’s Disease Current Activity Form (BDCAF)
Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group
Total Improvement Score (TIS) of the International Myositis Assessment Clinical Studies (IMACS) group
IgG4-RD responder index
IgG4-RD responder index
次要结局
- AUC for number of oral ulcers
- Cutaneous Dermatomyositis Disease Area and Severity index (CDASI)
- Total number of flares in each disease, measured by a ≥1 point increase in Physician Global Assessment (PGA) on a scale from 0-3
- Visual Analogue Scale (VAS) of disease activity, based on the clinical view of the local principal investigator
- Glucocorticoid Toxicity Index (GTI)
- Changes in glucocorticoid dose
- VAS score of pain, patients perspective
- Functional Assessment of Chronic Illness Therapy – Fatigue (FACIT-F)
- Patient Acceptable Symptom State (PASS)
- Exposure-adjusted incidence rates for treatment-emergent adverse events
研究者
Prof. dr. J.M. van Laar
Scientific
University Medical Center Utrecht
研究点 (6)
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