NL-OMON53878已完成4 期
Januse kinase Inhibition with Filgotinib to Silence Autoreactive B cells in Rheumatoid Arthritis - JAKAR
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
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
- 年龄范围
- 18 至 99（—）
入选标准
- •In order to be eligible to participate in this study, a subject must meet all
- •of the following criteria. Each patient must:
- •- have a diagnosis of RA and must have fulfilled the revised 2010 EULAR/ACR
- •criteria for classification of RA prior to initiation of first-line treatment.
- •- have a positive test for the presence of anti-citrullinated protein
- •antibodies (ACPA) in serum with a value of at least 200 U/ml, as determined by
- •routine clinical assay.
- •- have moderate to highly active disease defined by a disease activity score
- •evaluating 28 joints (DAS28) >= 3.2 or, correspondingly, an sDAI score of > 11.
- •- have used methotrexate therapy at a maximally tolerated dose once weekly for
- •at least 1 month; concomitant glucocorticoid therapy is allowed if at a stable
- •dose of <= 7.5 mg prednisolon equivalent within 30 days prior to entry in the
- •- have adequate hematologic function (ANC >= 4000 cells/µL, platelet count >=
- •150000/µL, and haemoglobin >= 10 g/dL (corresponding to 6.2 mmol/L)
- •- have a serum creatinine clearance of >15 ml/min
- •- be at least 18 years of age
- •- if female and of childbearing potential, agree to: comply with effective
- •contraceptive measures, use adequate contraception since the last menses and
- •use adequate contraception during the study
- •- be willing to undergo pre-treatment screening for latent tuberculosis
- •infection by chest X-ray and Mantoux testing as well as serological screening
- •for chronic viral hepatitis infection. As an alternative for the Mantoux test,
- •a standardized IFN-gamma release assay may be used to assess latent
- •tuberculosis infection.
- •- be able and willing to give written informed consent prior to entry in the
排除标准
- •A potential subject who meets any of the following criteria will be excluded
- •from participation in this study. Any patient who:
- •- has ever been treated with rituximab or another B-cell depleting agent
- •- has been treated with a biological DMARD (except rituximab) or a targeted
- •synthetic DMARD within 3 months prior to entry in the study
- •- has received intra-articular or systemic glucocorticoid injections within 30
- •days prior to baseline or requires narcotic analgesics other than those
- •accepted by the investigator for analgesia (e.g. paracetamol, NSAIDs, codeine,
- •* has been tested negative for ACPA
- •* is in clinical remission as defined by a disease activity score evaluating 28
- •joints (DAS28) <= 2.6 or, correspondingly, an sDAI <= 3.3
- •* has evidence of a medical condition which represents a contra-indication for
- •initiation of either a TNF-alpha inhibitor or a Janus kinase inhibitor, as
- •outlined in the most recent SPCs of either adalimumab and/or Filgotinib.
- •* has liver function abnormality (AST and/or ALT >= 3 x upper limit of normal
- •* has concurrent treatment with an experimental drug or who has participated in
- •another clinical trial with an investigational drug within 30 days prior to
- •study entry
- •* has past or current history of solid or haematological neoplasms, except for
- •curatively treated non-melanoma skin cancer, adequately treated in situ
- •carcinoma of the cervix or another cancer curatively treated and with no
- •evidence of disease for at least 10 years
- •* is pregnant or a currently nursing woman
- •* is, female and of childbearing potential, unwilling to use adequate
- •contraceptive measures during the study
研究者
相似试验
尚未招募
4 期
Januse Kinase Inhibition With Filgotinib to Silence Autoreactive B Cells in Rheumatoid ArthritisRheumatoid ArthritisNCT05502731Leiden University Medical Center40
尚未招募
1 期
Efficacy and safety of filgotinib for refractory pouchitis in patients with ulcerative colitisJPRN-UMIN000048070Hyogo medical university Department of Gastroenterological Surgery50
招募中
不适用
Therapeutic Targeting of Lyn Kinase with Nilotinib to Treat Chorea-Acanthocytosis - an observational, non-interventional studyG23.9Degenerative disease of basal ganglia, unspecifiedDRKS00024187Sektion für Translationale Neurodegeneration Albrecht KosselKlinik und Poliklinik für NeurologieUniversitätsmedizin Rostock10
进行中（未招募）
1 期
Efficacy and Tolerance of Baricitinib, a JAK Inhibitor, in the Treatment of Refractory Non-infectious Non-anterior Uveitis (JAKUVEITE)Active non-anterior non-infectious uveitisMedDRA version: 22.1Level: LLTClassification code: 10066681Term: Acute uveitis Class: 10015919CTIS2024-513802-77-00Centre Hospitalier Universitaire Rouen33
暂停
不适用
Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to conventional synthetic disease-modifying antirheumatic drugs: Comparative study with Filgotinib and interleukin 6 inhibitor examined by clinical index as well as musculoskeletal ultrasound assessment(TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trialRheumatoid arthritisJPRN-jRCTs071200107Kawakami Atsushi400